Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,216
Countries
16
Sites
89
Newly Diagnosed Multiple Myeloma (NDMM)
To compare the efficacy of iberdomide to that of lenalidomide in participants with NDMM after ASCT, as measured by PFS
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Sep 2023 → ongoing
- Decision date (initial)
- 2023-08-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Celgene Corporation
External identifiers
- EU CT number
- 2022-501515-14-00
- WHO UTN
- U1111-1280-9492
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacokinetic, Efficacy, Pharmacogenomic, Safety
To compare the efficacy of iberdomide to that of lenalidomide in participants with NDMM after ASCT, as measured by PFS
Secondary objectives 13
- To compare the MRD negativity rate (at a threshold of 10–5 by next-generation flow) in participants with a response of CR or better at 12 (± 3) months of maintenance treatment with iberdomide versus lenalidomide
- To evaluate OS in participants with NDMM after ASCT treated with iberdomide compared to lenalidomide
- In Stage 1, to inform the dose of iberdomide to continue in Stage 2 of the study
- In Stage 1, to assess the PK of iberdomide
- To evaluate safety of iberdomide maintenance compared to lenalidomide maintenance in participants with NDMM after ASCT
- To evaluate PFS on next line of treatment (PFS2) in participants with NDMM after ASCT when treated with iberdomide compared to lenalidomide
- To compare the overall rate of MRD negativity (at a threshold of 10-5 by next-generation flow) of iberdomide versus lenalidomide maintenance treatment in participants with a response of CR or better
- To evaluate the frequency of conversion from MRD-positive to MRD-negative in participants with a response of CR or better (at a threshold of 10-5 by next-generation flow), in participants with NDMM after ASCT when treated with iberdomide compared to lenalidomide
- To evaluate the sustainability of MRD negativity at a threshold of 10-5 by next generation flow, in participants with NDMM after ASCT when treated with iberdomide compared to lenalidomide
- To evaluate TTP in participants with NDMM after ASCT treated with iberdomide compared to lenalidomide
- To evaluate TTNT in participants with NDMM after ASCT treated with iberdomide compared to lenalidomide
- To evaluate the percentage of participants at study entry with a suboptimal response (PR, VGPR) improving to CR or better as well as maintaining best overall response for participants who enroll in the study at CR
- To evaluate cancer-related symptoms, multiple myeloma-specific symptoms, and HRQoL in participants with NDMM after ASCT treated with iberdomide compared to lenalidomide
Conditions and MedDRA coding
Newly Diagnosed Multiple Myeloma (NDMM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- At the time of diagnosis: Participants with confirmed diagnosis of symptomatic MM, defined as monoclonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy-proven plasmacytoma and documented MM satisfying at least 1 of the myeloma-defining events as detailed in the IMWG criteria for the diagnosis of myeloma.
- At enrollment: Eastern Cooperative Oncology Group performance status performance status score of 0, 1, or 2. Participant has received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory compound (IMiD) with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide and dexamethasone and followed by a single or tandem ASCT. Post-stem cell transplant consolidation is permitted. Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction who achieved at least a partial response after ASCT with or without consolidation, according to IMWG 2016 criteria.
- For participants who have not received consolidation therapy, the participant must be within 120 days of the last transplant at the time of randomization.
- For participants treated with consolidation therapy, the participant must be within 30-60 days of the last dose of consolidation therapy at the time of randomization and within 180 days of the last transplant at the time of randomization.
Exclusion criteria 8
- Participant has progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT or is not responsive to primary therapy.
- Participant has systemic amyloid light-chain amyloidosis or plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities (POEMS syndrome); or Waldenstrom’s macroglobulinemia.
- Participant has smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
- Participant has known central nervous system/meningeal involvement of MM.
- Participant has any of the following laboratory test result abnormalities: absolute neutrophil count < 1,000/μL; Platelet count: < 75,000/μL; Hemoglobin < 8 g/dL (<4.9 mmol/L; Creatinine clearance < 30 mL/min or requiring dialysis; Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L); Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal (ULN) or serum total bilirubin > 1.5 × ULN.
- Peripheral neuropathy of Grade ≥ 2.
- Received any prior B-cell maturation antigen directed therapy.
- Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, NK cells).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS, defined as the time from randomization to the first documentation of progressive disease according to International Myeloma Working Group (IMWG) Uniform Response Criteria for MM or death due to any cause, whichever occurs first
Secondary endpoints 13
- Achieving MRD negativity (at a threshold of 10–5 by next-generation flow) in participants who are in a response of CR or better at 12 (±3) months post start of maintenance treatmen
- OS, defined as the time from randomization to deathdue to any cause
- Recommended iberdomide dose for Stage 2
- PK of iberdomide
- Safety (type, frequency, seriousness, and severity of AEs), and relationship of AEs to study treatment
- PFS2 is defined as the time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first
- Achieving MRD negativity (at a threshold of 10-5 by next-generation flow) in participants with a response of CR or better at any time after the date of randomization
- Conversion from MRD-positive to MRD-negative in participants with a response of CR or better (at a threshold of 10-5 by next-generation flow)
- Achievement of a response of CR or better and maintaining MRD-negative status (at a threshold of 10-5 by next-generation flow) in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments
- TTP, defined as the time from randomization to the first documentation of disease progression according to IMWG Uniform Response Criteria for MM
- TTNT is defined as the time from randomization to the start of the participant receiving any anti myeloma treatment other than study treatment
- Best response achieved in participants who enroll with a suboptimal response (PR or VGPR), or CR or better prior to PD
- Subscale and total scores in patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30, EORTC QLQ-MY20
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD10086322 · Product
- Active substance
- Iberdomide
- Substance synonyms
- (3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10086311 · Product
- Active substance
- Iberdomide
- Substance synonyms
- (3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10086310 · Product
- Active substance
- Iberdomide
- Substance synonyms
- (3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10086309 · Product
- Active substance
- Iberdomide
- Substance synonyms
- (3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10086308 · Product
- Active substance
- Iberdomide
- Substance synonyms
- (3S)-3-(4-((4-((MORPHOLIN-4-YL)METHYL)PHENYL)METHOXY)-1-OXO-1,3-DIHYDRO-2H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, CC-220, (S)-3-(4-((4-(MORPHOLINOMETHYL)BENZYL)OXY)-1-OXOISOINDOLIN-2-YL)PIPERIDINE-2,6-DIONE
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 3
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 27300 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different packaging sites and additional manufacturers for clinical supplies are used; the clinical supplies may be packaged in bottles or blisters and contain no markings where as the commercial product is marked with REV X mg, where X is the dosage strength. Further information on the differences between the commercial and clinical presentation is available in Section 2.2.1.P of the simplified IMP dossier included in the application.
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 27300 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different packaging sites and additional manufacturers for clinical supplies are used; the clinical supplies may be packaged in bottles or blisters and contain no markings where as the commercial product is marked with REV X mg, where X is the dosage strength. Further information on the differences between the commercial and clinical presentation is available in Section 2.2.1.P of the simplified IMP dossier included in the application.
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 27300 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different packaging sites and additional manufacturers for clinical supplies are used; the clinical supplies may be packaged in bottles or blisters and contain no markings where as the commercial product is marked with REV X mg, where X is the dosage strength. Further information on the differences between the commercial and clinical presentation is available in Section 2.2.1.P of the simplified IMP dossier included in the application.
Auxiliary 5
Eliquis 2.5 mg film-coated tablets
PRD2351235 · Product
- Active substance
- Apixaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 9100 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — -
- Marketing authorisation
- EU/1/11/691/001
- MA holder
- BRISTOL-MYERS SQUIBB/PFIZER EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Aspirin 75mg gastro-resistant tablets
PRD1955945 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 136500 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- PA0126/246/001
- MA holder
- CLONMEL HEALTHCARE LTD.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xarelto 2.5 mg film-coated tablets
PRD4848675 · Product
- Active substance
- Rivaroxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 18200 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — -
- Marketing authorisation
- EU/1/08/472/041
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Clexane 10,000 IU (100mg)/1ml Solution for Injection in pre-filled syringes
PRD595160 · Product
- Active substance
- Enoxaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 72800 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- PA 540/97/1
- MA holder
- SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3301755 · Product
- Active substance
- Warfarin Sodium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 18200 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AA03 — WARFARIN
- Marketing authorisation
- PA 2050/001/001
- MA holder
- SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| EndPoint Clinical Inc. ORL-000012578
|
Wakefield, United States | Other |
| Parexel International Corp. ORG-100007310
|
Durham, United States | Code 10, Other |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 12, Other, Code 2, Code 8 |
| Q2 Solutions ORL-000000243
|
West Lothian, United Kingdom | Other |
| Ampersand Biosciences LLC ORG-100053411
|
Lake Clear, United States | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Other |
| Axio Research ORL-000010874
|
Seattle, United States | Other |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | Other |
| Fortrea Development Ltd. Branch Of Foreign Company ORG-100049638
|
Maroussi, Greece | On site monitoring, Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Cerba Research ORG-100042694
|
Gent, Belgium | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
Locations
16 EU/EEA countries · 89 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 15 | 4 |
| Belgium | Ongoing, recruiting | 7 | 2 |
| Czechia | Ongoing, recruiting | 46 | 5 |
| Denmark | Ongoing, recruiting | 7 | 1 |
| Finland | Ongoing, recruiting | 8 | 2 |
| France | Ongoing, recruiting | 96 | 15 |
| Germany | Ongoing, recruiting | 27 | 13 |
| Greece | Ongoing, recruiting | 14 | 6 |
| Hungary | Ongoing, recruiting | 5 | 1 |
| Italy | Ongoing, recruiting | 104 | 11 |
| Netherlands | Ongoing, recruiting | 7 | 2 |
| Poland | Ongoing, recruiting | 47 | 7 |
| Portugal | Ongoing, recruiting | 10 | 3 |
| Romania | Ongoing, recruiting | 16 | 5 |
| Spain | Ongoing, recruiting | 41 | 9 |
| Sweden | Ongoing, recruiting | 14 | 3 |
| Rest of world
Singapore, Taiwan, Switzerland, Turkey, Canada, Hong Kong, Israel, Argentina, China, Japan, India, Chile, Brazil, Colombia, United States, United Kingdom, Korea, Republic of, Australia, Mexico
|
— | 752 | — |
Investigational sites
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
3. Medical Department, Heinrich-Collin-Strasse 30/1100, Penzing, Vienna
Medical University Of Vienna
Department of Medicine I, Division of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Haematology with stem cell transplantation, haemostaseology and medical oncology, Fadingerstrasse 1, 4020, Linz
Universitatsklinikum St. Polten
Clinical Department of Internal Medicine I, Dunant-Platz 1, 3100, St. Poelten
Algemeen Ziekenhuis Groeninge
Hematology, President Kennedylaan 4, 8500, Kortrijk
Grand Hopital De Charleroi
Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Fakultni Nemocnice Kralovske Vinohrady
Hematologická klinika Ambulance pro monoklonální gamapatie a mnohočetný myelom (MM), Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice Brno
Interní Hematologická a Onkologická klinika, Jihlavska 340/20, Bohunice, Brno
University Hospital Olomouc
Hemato-onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Vseobecna Fakultni Nemocnice V Praze
I. interní klinika - klinika hematologie 1.LF a VFN, U Nemocnice 499/2, Nove Mesto, Prague 2
University Hospital Ostrava
Klinika Hematoonkologie, 17. Listopadu 1790/5, 708 00, Poruba
HUS Helsinki University Hospital
Hematology dept, Haartmaninkatu 4, 00290, Helsinki
Kuopio University Hospital
Hematology dept, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Departmental Hospital Vendee
Onco-hematology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire De Nantes
Clinical Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Universitaire Du Cancer Toulouse-Oncopole
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Limoges
Service d'hématologie clinique et thérapie cellulaire, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire Amiens Picardie
hematologie clinique et therapie cellulaire, 1 Place Victor Pauchet, 80080, Amiens
Centre Hospitalier Universitaire De Caen Normandie
Clinical Hematology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Lille
Blood Disease, Rue Michel Polonovski, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Lymphoid Hemopathies, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Hopital Saint Louis
immuno-hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Gustave Roussy
Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
University Hospitals Pitie Salpetriere Charles Foix
Blood Diseases and Cell Therapy, 47 To 83 Boulevard De L Hopital, 75013, Paris
Hopital Saint Antoine
hematology, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Antoine Lacassagne
Medical oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Hospitalier De La Cote Basque
Hematology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Lyon Sud
Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Universitaetsklinikum Tuebingen AöR
hematology and oncology, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Klinikum Chemnitz gGmbH
Innere Medizin III - Haematologie, Onkologie, Zelltherapie, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Augsburg
Innere Medizin, Haematologie und Onkologie, Stenglinstrasse 2, Kriegshaber, Augsburg
St. Barbara-Klinik Hamm GmbH
hematology and oncology, Am Heessener Wald 1, Heessen, Hamm
Universitaetsklinikum Ulm AöR
hematology, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 5 - Hamatologie und lnternistische Onkologie, Ulmenweg 18, Innenstadt, Erlangen
University Hospital Jena KöR
hematology, Am Klinikum 1, Lobeda, Jena
Asklepios Klinik Altona
Onkologie, Hämatologie, Palliativmedizin, Rheumatologie und Pneumologie, Paul-Ehrlich-Str. 1, 22763, Hamburg
LMU Klinikum Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Klinikum Bayreuth GmbH
Hämatologie und internistische Onkologie, Preuschwitzer Straße 101, 95445, Bayreuth
Medical University Of Lausitz Carl Thiem
2.Medizinische Klinik für Hämatologie, Onkologie, Nephrologie, Diabetologie und Pneumologie, Thiemstrasse 111, Spremberger Vorstadt, Cottbus
Medical Center - University Of Freiburg
hematology oncology, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie | CBF, Hindenburgdamm 30, Lichterfelde, Berlin
Theagenio Cancer Hospital of Thessaloniki
Hematology- Oncology Department, Alexandrou Simeonidi str 2, 54639, Thessaloniki
General University Hospital Of Larissa
Hematology clinic, P. O. Box 1425, 411 10, Larissa
Evangelismos S.A.
hematology clinic, Ipsiladou 45-47, 106 76, Athens
General University Hospital Of Patras
hematology oncology, Rio, 265 04, Patras
Alexandra Hospital
Clinical therapeutics national and kapodistrian university of Athens, Vassilissas Sofias Avenue 80, 115 28, Athens
General Hospital of Thessaloniki ""George Papanikolaou""
Hematology Department, Exohi Papanikolaou Avenue, 57010, Thessaloniki
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Hematology, Viale Del Policlinico 155, 00161, Rome
IRCCS Ospedale Policlinico San Martino
hematology, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
hematology, Largo Francesco Vito 1, 00168, Rome
ASST Grande Ospedale Metropolitano Niguarda
S.C. Hematology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione IRCCS Policlinico San Matteo
Hematology, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
hematology, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero Universitaria Careggi
Hematology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero Universitaria Pisana
oncology, Via Roma 67, 56126, Pisa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Hematology, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
UOC di Emotologia, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliera Universitaria Federico II Di Napoli
hematology, Via Sergio Pansini 5, 80131, Naples
Albert Schweitzer Ziekenhuis
Hematology, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Amsterdam UMC
Haematology, De Boelelaan 1117, 1081 HV, Amsterdam
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im.M.Kopernika W Lodzi
Oddział Hematologii i Transplantologii, Ul. Pabianicka 62, 93-513, Lodz
In Vivo Sp. z o.o.
NA, Ul. Kaszubska 17h, 85-048, Bydgoszcz
Pratia Hematologia Sp. z o.o.
-, Pratia Onkologia Katowice, ul. Kościuszki 92, Katowice
Centrum Onkologii Ziemi Lubelskiej Im Sw Jana Z Dukli
Oddział Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
CCAB Centro Clinico Academico Braga Associacao
Oncologia Médica, Lugar De Sete Fontes S Victor, 4710-243, Braga
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Onco-Hematologia, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Coimbra E.P.E.
Hematologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Institute Of Oncology Prof Dr Ion Chiricuta Cluj Napoca
Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Institute Of Oncology Prof Dr Ion Chiricuta Cluj Napoca
Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Fundeni Clinical Institute
Hematology, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Municipal Filantropia Craiova
Hematology, Str. Filantropiei, 1, Craiova
Institutul Regional De Oncologie Iasi
Hematology, Strada G Ral Berthelot 2-4, 700483, Jassi
University Hospital Son Espases
-, Carretera Valldemossa 79, 07120, Palma
Institut Catala D'oncologia
Clinic Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital San Pedro De Alcantara
-, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Central De Asturias
-, Avenida De Roma S/n, 33011, Oviedo
Hospital Clinic De Barcelona
-, Calle Villarroel 170, 08036, Barcelona
University Clinic Of Navarra
-, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Y Politecnico La Fe
-, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Gran Canaria Dr. Negrin
-, Barranco De La Ballena Sn, 35010, Las Palmas De Gran Canaria
University Clinical Hospital Virgen De La Arrixaca
-, Carretera De Cartagena S/n, El Palmar, Murcia
Region Norrbotten
-, Robertsviksgatan 7, Lulea Domkyrkofors., Lulea
NU Hospital Group-Vastra Gotalandsregionen
Hematologen, Larketorpsvagen, 461 85, Trollhattan
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
-, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-11-13 | 2023-12-20 | |||
| Belgium | 2024-12-24 | 2025-02-03 | |||
| Czechia | 2024-01-23 | 2025-01-07 | |||
| Denmark | 2023-11-27 | 2023-12-14 | |||
| Finland | 2023-11-23 | 2024-12-24 | |||
| France | 2023-10-06 | 2023-11-29 | |||
| Germany | 2023-09-29 | 2023-11-15 | |||
| Greece | 2023-10-30 | 2023-11-27 | |||
| Hungary | 2024-12-24 | 2024-12-24 | |||
| Italy | 2023-11-13 | 2024-01-11 | |||
| Netherlands | 2024-12-24 | 2025-04-29 | |||
| Poland | 2024-12-24 | 2024-12-24 | |||
| Portugal | 2023-10-27 | 2024-02-08 | |||
| Romania | 2023-10-27 | 2023-12-13 | |||
| Spain | 2023-10-11 | 2023-12-01 | |||
| Sweden | 2024-01-25 | 2025-08-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-84926
- Event date
- 2025-05-26
- Date aware
- 2025-05-26
- Submission date
- 2025-06-03
- Member states affected
- Portugal, Romania, Spain, Sweden, Poland, Austria, Czechia, Denmark, Finland, France, Italy, Germany, Greece, Hungary, Netherlands, Belgium
- Event description
- The sponsor would like to inform the MSc that due to potential risk of supply of medicine for participants on treatment of the ongoing Phase 3 IM048-022 study in maintenance therapy after transplant in NDMM patients, the Sponsor has decided to release drug supply with the previous approved labels for Iberdomide and Lenalidomide. The difference between both labels is the updated Sponsor’s address (previous labels have Summit address, while updated labels have Princeton address).
Subjects are currently receiving Iberdomide and Lenalidomide as part of this study. On 20Dec2024, as part of SM-8, the sponsor submitted revised labels for both IMPs to only change the address from Summit to Princeton. SM-8 was approved 04Apr2025 (Last country decision was received on 15Apr2025).
However, the new approved labelled materials are not yet available for use. As a result, the sponsor believes that the best approach to mitigate the risk of IMP supply to the subjects is to proceed with the previous approved labelled material, pending the availability of the material with updated label proofs. The sponsor would like to assure the MSc that the subjects’ treatment and safety in this trial remain of utmost importance to the sponsor and it is not impacted.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 237 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2022-501515-14-00 NSM_Fulfilment of condition-cl-signed_Redacted | N/A |
| Protocol (for publication) | D1_Protocol_2022-501515-14-00_GR_Redacted | 3.0 |
| Protocol (for publication) | D1_Protocol_2022-501515-14-00_Redacted | PA03 |
| Protocol (for publication) | D4_Patient facing documents_EORTC QLQ-MY20_German | NA |
| Recruitment arrangements (for publication) | K_Recruitment arrangements_Romanian | NA |
| Recruitment arrangements (for publication) | K1_Additional document requested relating to recruitment materials | NA |
| Recruitment arrangements (for publication) | K1_Additional document requested relating to recruitment materials-Study Connect | 1.0 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment and Informed consent procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment arrangements_Polish | 2.0 |
| Recruitment arrangements (for publication) | K1_PT_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedures_Hungary_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedures_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_German | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments | 2.0 |
| Recruitment arrangements (for publication) | K1_recruitment procedure_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_RO_Recruitment material Informed consent and Patient Recruitment Procedure_Romanian | 3.1 |
| Recruitment arrangements (for publication) | K1_SE_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K2_Display_Ads_Hungary | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment material_Display Ads_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment material_Flyer_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment material_Print Ad_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_ES_Recruitment material_Study Brochure_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_Flyer_Hungary | 2.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment material_Display Ads_Polish | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment material_Flyer_Polish | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment material_Patient Brochure_Polish | 1.0 |
| Recruitment arrangements (for publication) | K2_PL_Recruitment material_Print Ad_Polish | 1.0 |
| Recruitment arrangements (for publication) | K2_Print_Ad_Hungary | 2.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment arrangements_Flyer_Portuguese | 1.0 |
| Recruitment arrangements (for publication) | K2_PT_Recruitment arrangements_Study Brochure_Portuguese | 1.0 |
| Recruitment arrangements (for publication) | K2_Recritment material Study Brochure | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Display Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Display Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Display Ads_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Print Ad_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Brochure_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material__Study Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Display Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Display Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Display Ads_DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Display Ads_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Display Ads_French | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Display Ads_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Display_Ads | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_FRE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_GER | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_FRE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_GER | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print_Ad | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure_DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure_DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure_FRE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Brochure_GER | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment arrangements_Display Ads_Romanian | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment arrangements_Flyer_Romanian | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment arrangements_Print Ad_Romanian | 1.0 |
| Recruitment arrangements (for publication) | K2_RO_Recruitment arrangements_Study Brochure_Romanian | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Display Ads_Swedish | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Flyer_Swedish | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Print Ad_Swedish | 1.0 |
| Recruitment arrangements (for publication) | K2_SE_Study Brochure_Swedish | 1.0 |
| Recruitment arrangements (for publication) | K2_Study Brochure_Hungary | 2.0 |
| Subject information and informed consent form (for publication) | L_Subject information and informed consent form_2022-501515-14-00_Statement | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Genomic Research_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Genomic Research_Tracked_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Greenphire_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Greenphire_Tracked_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Italian_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Tracked_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_Italian_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Participant_Italian_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Participant_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Participant_Tracked_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner ICF_Italian_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_Tracked_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Privacy Information Sheet_Italian_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Request form for the Discontinuation of participation_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ICF_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Participant_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_Swedish_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_EC confirmation_condition 3 part II_Spanish | N/A |
| Subject information and informed consent form (for publication) | L1_ES_Greenphire Travel Reimbursement Notice_Spanish | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_Main ICF_Spanish_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ES_Main ICF_Spanish_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_Optional Future Research ICF_Spanish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_Pregnant Participant ICF_Spanish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_Pregnant Partner ICF_Spanish_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Future Research_Hungarian_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Polish_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Romanian_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional future research_Dutch_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional future research_English_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional future research_French_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Polish_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Patient Reimbursement_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Polish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Romanian_Redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Polish_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Romanian_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_centre-specific contact list_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_centre-specific contact list_TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidentiality Notice_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic PIS_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF_Dutch_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF_English_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF_English_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF_French_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF_Greek | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_Finnish_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main_Greek_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Pregnant Participant_Finnish_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Pregnant Partner_Finnish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Danish_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Danish_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Dutch_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Dutch_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_English_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_English_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_French_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_German_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main PIS and ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main PIS and ICF_TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_German_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_German_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Hungarian_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Hungarian_Track changes_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Swedish_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research IC_Finnish_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF_Danish_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF_Dutch_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF_English_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Personal Data Processing for the Greenphire_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Danish_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Danish_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Dutch_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_English_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_German_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Greek_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Redacted_English | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Redacted_French | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_Hungarian_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_Swedish_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Danish_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Danish_TC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Dutch_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Dutch_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_English_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_English_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_French_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_German_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Greek_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_German_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Hungarian_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Future Research_Hungarian_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information lberdomide pregnancy prevention plan_Italian | 7 |
| Subject information and informed consent form (for publication) | L2_Other subject information Lenalidomide Pregnancy Plan_Italian | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Greenphire_TC | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material lberdomide global pregancy prevention plan_Polish | 7.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material lberdomide global pregnancy prevention plan_TC | 8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Lenalidomide Adult Pregnancy Risk Minimization Plan_Polish | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Lenalidomide Adult Pregnancy Risk Minimization Plans_TC | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ICF_Finnish | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lenalidomide Adult Pregnancy Risk Minimization Plan_Finnish | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lenalidomide Adult Pregnancy Risk Minimization Plan_Greek | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAC | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PAC_track changes | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_lberdomide global pregnancy prevention plan_Finnish | 8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_lberdomide global pregnancy prevention plan_Greek | 4 |
| Subject information and informed consent form (for publication) | M1_Study Sites and Investigators_TC_Redacted | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide | 54 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_2022-501515-14-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_AT_2022-501515-14-00_German | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_BE_2022-501515-14-00_Dutch_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_BE_2022-501515-14-00_French_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_BE_2022-501515-14-00_German_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_CZ_2022-501515-14-00_Czech_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_DE_2022-501515-14-00_German | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_DK_2022-501515-14-00_Danish | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_ES_2022-501515-14-00_Spanish_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_FR_2022-501515-14-00_French_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_GR_2022-501515-14-00_Greek_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_HU_2022-501515-14-00_Hungarian_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_IT_2022-501515-14_Italian_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_NDL_2022-501515-14-00_Dutch_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_PL_2022-501515-14-00_Polish_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_PT_2022-501515-14-00_Portugese_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_RO_2022-501515-14-00_Romanian_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_SE_2022-501515-14-00_Swedish_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_AT_2022-501515-14-00_de-AT_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_HU_2022-501515-14-00_Hungarian | 3 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-18 | Finland | Acceptable with conditions 2023-08-14
|
2023-08-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-02 | Finland | Acceptable with conditions 2023-08-14
|
2023-10-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-10-04 | Finland | Acceptable with conditions 2023-08-14
|
2023-10-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-11 | Acceptable with conditions | 2023-12-28 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-11 | Acceptable with conditions | 2023-12-12 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-11 | Acceptable with conditions | 2023-11-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-10-18 | Acceptable with conditions | 2023-11-28 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2023-10-30 | Acceptable with conditions 2023-08-14
|
2024-01-22 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-15 | Finland | Acceptable 2024-05-14
|
2024-05-14 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-09-02 | Finland | Acceptable 2024-05-14
|
2024-09-02 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-12-17 | Acceptable 2024-05-14
|
||
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-20 | Finland | Acceptable 2025-04-04
|
2025-04-04 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-29 | Acceptable | 2025-05-30 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-04-30 | Acceptable | 2025-06-04 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-07-14 | Acceptable | 2025-07-14 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-08-06 | Acceptable | 2025-09-12 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-08-08 | Acceptable | 2025-09-04 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-01-28 | Finland | Acceptable 2026-04-22
|
2026-04-22 |