Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,060
Countries
12
Sites
82
Multiple myeloma
Part 1 • To assess dose limiting toxicities DLTs of EDR to select an RP3D for the combination to be used in Part 2 of this study. Part 2 • To compare the efficacy of Arm A (EDR) vs Arm B (D-VRd) as measured by MRD status and PFS
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Nov 2022 → ongoing
- Decision date (initial)
- 2024-08-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514139-50-00
- EudraCT number
- 2021-000803-20
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Efficacy, Pharmacokinetic, Therapy, Pharmacoeconomic, Safety
Part 1
• To assess dose limiting toxicities DLTs of EDR to select an RP3D for the combination to be
used in Part 2 of this study.
Part 2
• To compare the efficacy of Arm A (EDR) vs Arm B (D-VRd) as measured by MRD status and PFS
Secondary objectives 6
- Part 1 To evaluate the overall safety profile of EDR or ER to select an RP3D for the combination to be used in Part 2 of this study.
- To evaluate the efficacy of EDR or ER to select an RP3D for the combination to be used in Part 2 of this study.
- To evaluate the PK of elranatamab when used in the EDR or ER combinations
- To evaluate the immunogenicity of elranatamab when used in the EDR or ER combinations (Part 1 only).
- To evaluate the PK of daratumumab and lenalidomide when used in EDR or ER combinations
- Part 2. To compare the efficacy of Arm A (EDR) vs Arm B (D-VRd) as measured by OS
Conditions and MedDRA coding
Multiple myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003083-PIP01-21
- Plan to share IPD
- No
- IPD plan description
- Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- Participants must meet the following inclusion criteria to be eligible for enrollment into the study. Criteria are for both Part 1 and Part 2 unless otherwise specified: Age and Sex:Participant's age ≥18 years (or the minimum country specific age of consent if >18) at Visit 1 (Screening).
- Adequate hepatic, renal, and bone marrow (BM) function (absolute neutrophil count [ANC], platelet count, hemoglobin).
- Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L).
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Type of Participant and Disease Characteristics: Diagnosis of multiple myeloma (MM) as defined according to IMWG criteria.
- Measurable disease based on IMWG criteria as defined by at least 1 of the following (as assessed by the central laboratory for Part 2)
- Serum M-protein ≥0.5 g/dL (Part 1) and ≥1g/dL (Part 2)
- Involved free light chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Part 1 only: Participant with NDMM or RRMM. NDMM participant must be transplant-ineligible. In Part 1 transplant-ineligible is defined by age ≥65 years or by age <65 years with comorbidities impacting the possibility of transplant. Participants with RRMM must have received 1-2 prior lines of MM therapy including at least one immunomodulatory drug (IMiD) and one proteasome inhibitor (PI).
- • Part 2 only: Participant has NDMM and is transplant-ineligible. In Part 2, transplant-ineligible is defined as: • Participants not considered candidates for high-dose chemotherapy and ASCT due to age or • Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Exclusion criteria 14
- Medical Conditions: Smoldering MM.
- Monoclonal gammopathy of undetermined significance (MGUS).
- Plasma cell leukemia.
- Waldenström`s Macroglobulinemia.
- Systemic light chain amyloidosis.
- Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin abnormalities (POEMS) Syndrome.
- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment.
- • Ongoing Grade 3 (Part 1)/Grade 2 (Part 2) or higher peripheral sensory or motor neuropathy, history of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade >3 (Part 1)/Grade >2 (Part 2) peripheral motor polyneuropathy.
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) coronavirus disease 2019 (COVID-19)/severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. Active infections must be resolved at least 21 days prior to enrollment. Participants treated with systemic therapeutic anti-infective agents within 28 days prior to enrollment are not eligible. Prophylactic use of systemic anti-infective agents is permitted.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
- Participants with known or suspected hypersensitivity to the study interventions or any of their excipients.
- Participants with known or suspected central nervous system (CNS) or clinical signs of myelomatous meningeal involvement.
- Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery that may significantly alter the absorption of oral drugs. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed (assuming no drug interaction potential).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Part 1: DLTs during the DLT observation period:For all dose levels (DLs) except DL F: From the first priming dose of elranatamab in the 2 Step-up Priming Dose Period until 28 days (± visit windows) from the first administration of the EDR combination.
- For DL F: 28 days (± visit windows) from the day of the first full dose of elranatamab (76 mg) in combination with daratumumab (D) and lenalidomide (R.).
- Part 2: MRD negative CR rate (central lab) at 12 months after randomization per IMWG as assessed via next generation sequencing (NGS)
- PFS per IMWG
Secondary endpoints 18
- Part 1: Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), timing, seriousness, and relationship to study treatment. Severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
- Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing.
- Objective response rate (ORR) and complete response rate (CRR,), per International Myeloma Working Group (IMWG) response criteria as determined by investigator.
- Time to event endpoints: time to response (TTR, ), duration of response (DOR, ), duration of complete response (DOCR) and progression-free survival (PFS) per IMWG response criteria as determined by investigator, and overall survival (OS;);
- • Minimal residual disease (MRD) negative CR rate (central laboratory) per IMWG sequencing criteria.
- Predose and post dose concentrations of elranatamab against elranatamab
- Anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against elranatamab
- Predose concentrations of daratumumab and lenalidomide
- Part 2 Key Secondary: OS
- Secondary: Overall MRD negative CR rate per IMWG
- Duration of MRD negative CR per IMWG
- PFS and progression-free survival on next line of therapy (PFS2) by investigator per IMWG
- ORR, CRR, TTR, DOR, and DOCR per IMWG
- AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study treatment. The severity of CRS and ICANS will be graded according to ASTCT criteria (Lee, 2019).
- Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing.
- Predose and post dose concentrations of elranatamab.
- ADAs and NAbs against elranatamab.
- EORTC QLQ-C30 and MY20European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC30) and Myeloma Module 20 (MY20).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10297333 · Product
- Active substance
- Elranatamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 76 mg milligram(s)
- Max total dose
- 76 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 13
PRD9398502 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 21-0051
- MA holder
- NORAMEDA UAB
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD9398498 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- LT/1/21/4758/001
- MA holder
- NORAMEDA UAB
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD9398505 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 1027321
- MA holder
- NORAMEDA UAB
- MA country
- Estonia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD10184458 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 29831/0677
- MA holder
- WOCKHARDT UK LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD11157832 · Product
- Active substance
- Dexamethasone
- Substance synonyms
- DEXAMETASONE, DEXAMETHASONUM
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 17780/1138
- MA holder
- ZENTIVA PHARMA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD9398499 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- LT/1/21/4758/002
- MA holder
- NORAMEDA UAB
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 1800 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
VELCADE 3.5 mg powder for solution for injection
PRD3349073 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1.3 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1.3 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD8721724 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00505
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD8721730 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00501
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD8721744 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00507
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD8721745 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00502
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
PRD8721704 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00504
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
Auxiliary 1
Privigen 100 mg/ml solution for infusion
PRD339233 · Product
- Active substance
- Human Normal Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 4.8 ml millilitre(s)
- Max total dose
- 4.8 ml millilitre(s)
- Max treatment duration
- 73 Month(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/002
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and/or labeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| WCG Clinical Inc. ORG-100040730
|
Eden Prairie, United States | Other |
| Delve Bio, Inc. ORL-000017545
|
Boston, United States | Laboratory analysis |
| Adaptive ORL-000007821
|
Seattle, United States | Other |
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Other |
| Signant Health ORL-000007176
|
London, United Kingdom | Other |
| Massive Bio Inc. ORG-100044618
|
Boca Raton, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Premier Research ORL-000007822
|
Durham NC, United States | Data management |
Locations
12 EU/EEA countries · 82 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 24 | 10 |
| Belgium | Authorised, recruitment pending | 12 | 7 |
| Czechia | Ongoing, recruiting | 49 | 3 |
| Denmark | Ended | 12 | 4 |
| Finland | Authorised, recruitment pending | 15 | 5 |
| France | Ongoing, recruiting | 61 | 7 |
| Germany | Authorised, recruiting | 27 | 9 |
| Greece | Ongoing, recruiting | 17 | 4 |
| Italy | Ongoing, recruiting | 110 | 14 |
| Netherlands | Ongoing, recruiting | 10 | 2 |
| Poland | Ongoing, recruiting | 14 | 3 |
| Spain | Ongoing, recruiting | 93 | 14 |
| Rest of world
New Zealand, Canada, Brazil, United States, United Kingdom, Turkey, Israel, Korea, Republic of, Argentina, China, India, Taiwan, Switzerland, Australia, Mexico
|
— | 616 | — |
Investigational sites
Ordensklinikum Linz GmbH
Abteilung für Medizinische Hämatologie und Onkologie, Seilerstaette 4, 4010, Linz
Medizinische Universitaet Innsbruck
Abteilung für Innere Medizin, Anichstrasse 35, 6020, Innsbruck
Universitätsklinik für Innere Medizin III Salzburg
Hämatologie, Müllner Hauptstrasse 48, 5020, Salzburg
Universitatsklinikum St. Polten
Klinische Abteilung für Innere Medizin 1, Dunant Platz 1, 3100, Sankt Polten
Universitatsklinik für Innere Medizin Graz
Abteilung für Innere Medizin, Auenbrugger Platz 38, 8036, Graz
Stadt Wien Wiener Gesundheitsverbund
Medizinische Abteilung Zentrum für Onkologie und Hämatologie, Montleartstrasse 37, Ottakring, Vienna
Landeskrankenhaus Feldkirch
Abteilung für Interne E, Valdunastr. 16, 6830, Rankweil
Klinikum Wels-Grieskirchen GmbH
Abteilung für Innere Medizin IV, Grieskirchner Strasse 42, 4600, Wels
Medical University Of Vienna
University Department of Internal Medicine I, Division of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH
Klinik für Hämatologie und Onkologie, Stumpergasse 13, 1060, Vienna
Grand Hopital De Charleroi
Oncology & Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Algemeen Ziekenhuis Delta
NA, Deltalaan 1, 8800, Roeselare
Clinique Saint-Pierre
NA, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
UZ Brussel
NA, Laarbeeklaan 101, 1090, Jette
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
NA, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
University Hospital Olomouc
Hemato-onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
I. interní klinika – klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Rigshospitalet
N/A, Blegdamsvej 9, 2100, Copenhagen Oe
Lillebaelt Hospital
N/A, Beriderbakken 4, 7100, Vejle
Odense University Hospital
Dep. of Hematology, J. B. Winsloews Vej 4, 5000, Odense C
Aarhus Universitetshospital
Blodsygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
HUS-Yhtymae
Department of Hematology, Haartmaninkatu 4, 00290, Helsinki
Kymenlaakson keskussairaala
N/A, Kotkantie 41, 48210, Kotka
Kuopio University Hospital
Department of Oncology, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Turku University Hospital
N/A, Kiinamyllynkatu 4-8, 20520, Turku
Oulu University Hospital
Department of Oncology and Hematology, Kiviharjuntie 7, 90220, Oulu
Centre Hospitalier Universitaire De Nice
Hematology, 151 Route De Saint Antoine, 06200, Nice
Hopital Saint Antoine
Hematology and Cellular Therapy, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Institut Gustave Roussy
Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
CHU Bretonneau
Hematology and cell therapy, 2 boulevard Tonnelé, 37044, Tours
Centre Hospitalier Universitaire De Poitiers
Hematology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Nantes
Hematology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Toulouse
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik, Abteilung II, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Medical Center - University Of Freiburg
Kinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzellentransplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Medizinische Klinik und Poliklinik für Hämatologie und Onkologie, Langenbeckstr.1, 55131, Mainz
Universitaetsklinikum Regensburg AöR
Klninik für Onkologie, Hämatologie, Palliativmedizin,, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Ulm AöR
Zentrum für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Staedtisches Klinikum Braunschweig gGmbH
Medizinische Klinik, Abteilung III, Celler Strasse 38, 38114, Brunswick
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Asklepios Kliniken Hamburg GmbH
Klninik für Onkologie, Hämatologie, Palliativmedizin, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Pauwelsstrasse 30, 52074, Aachen
Alexandra Hospital
Oncology, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Of Ioannina
Haematology, Niarchou Stavrou Avenue, 455 00, Ioannina
Theageneio Cancer Hospital
Hematlogy/Oncology, Simeonidi Alex 2, 546 39, Thessaloniki
Evaggelismos Hospital
Hematology and Lymphoma Clinic - Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
UOC Ematologia, Piazza Oms 1, 24127, Bergamo
Centro Di Riferimento Oncologico Di Aviano
Oncologia Medica, Via Franco Gallini 2, 33081, Aviano
ASL PESCARA-Presidio Ospedaliero Pescara
Dipartimento Oncologico Ematologico, Via Fonte Romana 8, 65124, Pescara
Azienda Ospedaliero Universitaria Pisana
U.O. Ematologia, Via Roma 67, 56126, Pisa
Fondazione IRCCS San Gerardo Dei Tintori
Ematologia Adulti, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino- Presidio Molinette
Hematology U Division / SSD Clinical Trial in Oncohematology and Multiple Myeloma, via Genova 3, 10126, Torino
Ospedale Santa Maria delle Croci
Dipartimento di Oncologia ed Ematologia, V. Le Randi 5, 48121, Ravenna
Azienda Ospedaliera G. Brotzu
S.C. Ematologia e CTMO, Piazzale Ricchi 1, 9047, Cagliari
Azienda Unita Sanitaria Locale Di Piacenza
Oncologia ed Ematologia, Via Giuseppe Taverna 49, 29121, Piacenza
Istituto Europeo Di Oncologia S.r.l.
Divisione di Oncoematologia, Via Giuseppe Ripamonti 435, 20141, Milan
Casa Sollievo Della Sofferenza
U.O.C. di Ematologia e Trapianto di Cellule Staminali Emopoietiche, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliera Universitaria Senese - (ITT) - Center for Immuno-Oncology (CIO)
U.O.C. Ematologia, Viale Mario Bracci 16, 53100, Siena
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
U.O. Ematologia, Via Del Vespro 129, 90127, Palermo
AOU Policlinico Umberto I -Università degli studi di Roma "La Sapienza"
Dipartimento di medicina traslazionale e di precisione, Via Benevento 6, 00161, Rome
Albert Schweitzer Ziekenhuis
Internal Medicine, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Pratia Hematologia Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
"Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku", Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitario Regional De Malaga
N/A, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Clinic De Barcelona
N/A, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Y Politecnico La Fe
Hematología y Hemoterapia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario De Santiago
N/A, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Mutua Terrassa
N/A, Plaza del Dr. Robert 5, 08221, Terrassa
Institut Catala D'oncologia
Haematology Department, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario De La Princesa
N/A, Calle De Diego De Leon 62, 28006, Madrid
Hospital Germans Trias I Pujol
Instituto Catalán de Oncología de Badalona, Carretera Canyet 1a Planta, 08916, Badalona
Clinica Universidad De Navarra
N/A, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Marques De Valdecilla
N/A, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Hematología Clínica, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario Fundacion Jimenez Diaz
N/A, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Dr Peset Aleixandre
N/A, Avinguda De Gaspar Aguilar 90, 46017, Valencia
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 |
|---|---|---|---|---|---|
| Czechia | 2023-02-22 | 2023-03-29 | |||
| France | 2023-07-12 | 2023-08-23 | |||
| Germany | 2023-11-24 | ||||
| Greece | 2023-07-25 | 2023-08-02 | |||
| Italy | 2023-08-08 | 2023-09-19 | |||
| Netherlands | 2024-07-24 | 2025-05-23 | |||
| Poland | 2022-11-14 | 2022-12-06 | |||
| Spain | 2023-03-01 | 2023-05-17 | |||
| Austria | |||||
| Belgium | |||||
| Denmark | |||||
| Finland |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 7 · Art. 38 CTR
Temporary halt TH-105989
- Halt date
- 2025-10-29
- Member states concerned
- Spain
- Publication date
- 2025-11-12
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-105986
- Halt date
- 2025-10-29
- Member states concerned
- Germany
- Publication date
- 2025-11-12
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-106992
- Halt date
- 2025-11-05
- Member states concerned
- Netherlands
- Publication date
- 2025-11-19
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108347
- Halt date
- 2025-11-13
- Member states concerned
- Italy
- Publication date
- 2025-11-27
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-105983
- Halt date
- 2025-10-29
- Member states concerned
- France
- Publication date
- 2025-11-12
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-105692
- Halt date
- 2025-10-27
- Member states concerned
- Greece
- Publication date
- 2025-11-10
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108344
- Halt date
- 2025-11-13
- Member states concerned
- Czechia
- Publication date
- 2025-11-27
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 239 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Approval form_2024-514139-50-00_C1071006_EN_public | PA9 |
| Protocol (for publication) | D1_Protocol_2024-514139-50-00_C1071006_EN_PA7_EU CTR PACL_public | NA |
| Protocol (for publication) | D1_Protocol_2024-514139-50-00_C1071006_EN_PA7_PA7_PACL_ePhotocopy_public | NA |
| Protocol (for publication) | D1_Protocol_2024-514139-50-00_C1071006_EN_Public | PA9 |
| Protocol (for publication) | D1_Protocol_2024-514139-50-00_C1071006_EN_redline | PA9 |
| Protocol (for publication) | D1_Protocol_2024-514139-50-00_C1071006_GR_public | PA9 |
| Recruitment arrangements (for publication) | C1071006_blank file Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment and Informed Consent Procedure_C1071006_GR_EN_Public | 2.0 |
| Recruitment arrangements (for publication) | K1 Recruitment and informed consent procedure_C1071006_NL_EN_Public | NA |
| Recruitment arrangements (for publication) | K1 Recruitment and Informed Consent procedure_C1071006_PL_PL_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment_and_Consent procedure_C1071006_FI_FI_Public | N/A |
| Recruitment arrangements (for publication) | K1_1 Recruitment and Informed Consent Procedure_C1071006_BE_EN_Public | N/A |
| Recruitment arrangements (for publication) | K1_1 Recruitment and Informed Consent Procedure_C1071006_IT_EN_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_1_Recruitment and Informed Consent Procedure_C1071006_AT_EN_Public | N/A |
| Recruitment arrangements (for publication) | K1_1_Recruitment and Informed Consent Procedure_C1071006_DE_EN_Public | 3 |
| Recruitment arrangements (for publication) | K1_1_Recruitment and Informed Consent Procedure_C1071006_ES_EN_Public | 3 |
| Recruitment arrangements (for publication) | K1_1_Recruitment and Informed Consent Procedure_C1071006_FR_FR_Public | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent procedure_C1071006_DK_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recuitment and Informed consent procedure_C1071006_CZ_CS-EN_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_1 MagnetisMM Program_Clinic poster_C1071006_GR_EL_Public | 1 |
| Recruitment arrangements (for publication) | K2_1 Recruitment material_C1071006_ProgramStudyPage_FR-FR_Public | 3 |
| Recruitment arrangements (for publication) | K2_1 Study Flyer_C1071006_NL_NL_Public | 4.1 |
| Recruitment arrangements (for publication) | K2_1_Brochure Insert BLT_C1071006_DK_DA-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_1_Recruitment Material Clinic poster_C1071006_IT_IT_Public | 4 |
| Recruitment arrangements (for publication) | K2_1_Recruitment Material_Clinical Trials_C1071006_PL_PL_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_1_Recruitment Material_Patient Study Brochure_C1071006_BE_EN_Public | 4 |
| Recruitment arrangements (for publication) | K2_1_Recruitment Material_ProgramStudyPage_C1071006_CZ_CS_Public | 3 |
| Recruitment arrangements (for publication) | K2_10 Recruitment Material_General FAQs_C1071006_FR_FR_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_10_Multiple Myeloma Storyboard ME_C1071006_NL_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_10_Part 2_Informed Consent Aid ME_C1071006_GR_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_10_PCT_About Clinical Trials Fact Sheet_C1071006_DK_DA_Public | 1 |
| Recruitment arrangements (for publication) | K2_10_Recruitment material Brochure Insert_ME_C1071006_IT_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_10_Recruitment Material_Informed consent aid_C1071006_PL_PL_Public | 2 |
| Recruitment arrangements (for publication) | K2_10_Recruitment Material_Steps To Join_C1071006_CZ_CS_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_11_Multiple Myeloma Storyboard OST_C1071006_NL_NL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_11_Part 2_Informed Consent Aid BLT_C1071006_GR_EL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_11_PCT_BMA Flyer_C1071006_DK_DA_Public | 1 |
| Recruitment arrangements (for publication) | K2_11_Recruitment material Brochure Insert_BLT_C1071006_IT_IT-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_11_Recruitment Material_Privacy_C1071006_CZ_CS_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_11_Recruitment Material_Study visit guide_C1071006_PL_PL_Public | 2 |
| Recruitment arrangements (for publication) | K2_12_Multiple Myeloma Storyboard ME_C1071006_DK_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_12_Multiple Myeloma Storyboard VO_C1071006_NL_NL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_12_Part 2_Brochure Insert ME_C1071006_GR_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_12_Recruitment Material_Clinical Trial Tiles_C1071006_PL_PL_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_12_Recruitment Material_General FAQs_C1071006_CZ_CS_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_12_Recruitment material_Multiple Myeloma Storyboard ME_C1071006_IT_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_13_Multiple Myeloma Storyboard_VO_C1071006_DK_DA-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_13_Part 2_Brochure Insert BLT_C1071006_GR_EL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_13_Program-level Brochure_C1071006_NL_NL_Public | 4.1 |
| Recruitment arrangements (for publication) | K2_13_Recruitment material Multiple Myeloma Storyboard VO_C1071006_IT_IT-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_13_Recruitment Material_Clinical Trial Tiles_C1071006_CZ_CS_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_13_Recruitment Material_Program Study Page_C1071006_PL_PL_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_14_Multiple Myeloma Storyboard ME_C1071006_GR_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_14_Multiple Myeloma Storyboard_OST_C1071006_DK_DA-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_14_PCT About Clinical Trials Fact Sheet_C1071006_NL_NL_Public | 1 |
| Recruitment arrangements (for publication) | K2_14_Recruitment material Multiple Myeloma Storyboard OST_C1071006_IT_IT-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_15_Brochure Insert Part 2 _C1071006_CZ_CS_Public | 2 |
| Recruitment arrangements (for publication) | K2_15_Multiple Myeloma Storyboard VO_C1071006_GR_EL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_15_PCT BMA Flyer_C1071006_NL_NL_Public | 1 |
| Recruitment arrangements (for publication) | K2_16_Multiple Myeloma Storyboard OST_C1071006_GR_EL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_2 Clinic Poster_C1071006_NL_NL_Public | 4 |
| Recruitment arrangements (for publication) | K2_2 MagnetisMM Program_Study flyer_C1071006_GR_EL_Public | 4.1 |
| Recruitment arrangements (for publication) | K2_2 Recruitment Material Study flyer_C1071006_IT_IT_Public | 4 |
| Recruitment arrangements (for publication) | K2_2_Brochure Insert ME_C1071006_DK_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_2_Recruitment Material_Brochure insert Part 1_C1071006_CZ_CS_Public | 3 |
| Recruitment arrangements (for publication) | K2_2_Recruitment Material_Patient Study Brochure_C1071006_BE_FR_Public | 4 |
| Recruitment arrangements (for publication) | K2_2_Recruitment Material_Privacy_C1071006_PL_PL_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_2Recruitment Material_Informed consent aid_C1071006_FR_FR_Public | 2 |
| Recruitment arrangements (for publication) | K2_3 Informed Consent Aid Part 1_C1071006_NL_NL_Public | 3 |
| Recruitment arrangements (for publication) | K2_3 Part 1_Brochure insert_C1071006_GR EL_Public | 3 |
| Recruitment arrangements (for publication) | K2_3_Informed Consent Aid BLT_C1071006_DK_DA-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_3_Recruitment material Program-level Brochure_C1071006_IT_IT_Public | 4 |
| Recruitment arrangements (for publication) | K2_3_Recruitment Material_General FAQs_C1071006_PL_PL_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_3_Recruitment Material_Patient Study Brochure_C1071006_BE_NL_Public | 4 |
| Recruitment arrangements (for publication) | K2_3_Recruitment Material_Program level Brochure_C1071006_CZ_CS_Public | 4 |
| Recruitment arrangements (for publication) | K2_3_Recruitment Material_Program Level Brochure_C1071006_FR_FR_Public | 4 |
| Recruitment arrangements (for publication) | K2_4 Part 1_Informed consent aid_C1071006_GR EL_Public | 3 |
| Recruitment arrangements (for publication) | K2_4 Recruitment Material_Clinic poster_C1071006_FR_FR_Public | 1 |
| Recruitment arrangements (for publication) | K2_4_Informed Consent Aid ME_C1071006_DK_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_4_Informed Consent Aid Part 2_ME_C1071006_NL_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_4_Recruitment material PCT BMA Flyer_C1071006_IT_IT_Public | 1 |
| Recruitment arrangements (for publication) | K2_4_Recruitment Material_Clinic poster_C1071006_CZ_CS_Public | 1 |
| Recruitment arrangements (for publication) | K2_4_Recruitment Material_Homepage_C1071006_PL_PL_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_5 Recruitment Material_Study flyer_C1071006_FR_FR_Public | 1 |
| Recruitment arrangements (for publication) | K2_5_Informed Consent Aid Part 2_BLT_C1071006_NL_NL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_5_MagnetisMM Program_Program-level Brochure_C1071006_GR_EL_Public | 4.1 |
| Recruitment arrangements (for publication) | K2_5_Recruitment material PCT About Clinical Trials Fact Sheet_C1071006_IT_IT_Public | 1 |
| Recruitment arrangements (for publication) | K2_5_Recruitment Material_StepsToJoin_C1071006_PL_PL_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_5_Recruitment Material_Study flyer_C1071006_CZ_CS_Public | 1 |
| Recruitment arrangements (for publication) | K2_5_Video Postcard BLT_C1071006_DK_DA-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_6 Recruitment Material_Clinical Trials_C1071006_FR_FR_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_6_PCT_About Clinical Trials Fact Sheet_C1071006_GR_EL_Public | 1 |
| Recruitment arrangements (for publication) | K2_6_Recruitment material Video Postcard_ME_C1071006_IT_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_6_Recruitment Material_Program level Brochure_C1071006_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K2_6_Recruitment Material_Study visit guide_C1071006_CZ_CS_Public | 3 |
| Recruitment arrangements (for publication) | K2_6_Video Postcard ME_C1071006_DK_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_6_Video Postcard_ME_C1071006_NL_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_7 Recruitment Material_Homepage_C1071006_FR_FR_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_7_MagnetisMM Program Clinic poster_C1071006_DK_DA_Public | 4 |
| Recruitment arrangements (for publication) | K2_7_PCT_BMA Flyer_C1071006_GR_EL_Public | 1 |
| Recruitment arrangements (for publication) | K2_7_Recruitment material Video Postcard_BLT_C1071006_IT_IT-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_7_Recruitment Material_Clinic poster_C1071006_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K2_7_Recruitment Material_Informed consent aid_C1071006_CZ_CS_Public | 1 |
| Recruitment arrangements (for publication) | K2_7_Video Postcard_BLT_C1071006_NL_NL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_8 Recruitment Material_Steps To Join_C1071006_ FR_FR_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_8_Brochure Insert Part 2_ME_C1071006_NL_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_8_MagnetisMM Program_Program-level Brochure_C1071006_DK_DA_Public | 4 |
| Recruitment arrangements (for publication) | K2_8_Recruitment Material_Clinical Trials_C1071006_CZ_CS_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_8_Recruitment material_Recruitment material Informed Consent Aid_C1071006_IT_IT_Public | 2 |
| Recruitment arrangements (for publication) | K2_8_Recruitment Material_Study flyer_C1071006_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K2_8_Video Postcard ME_C1071006_GR_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_9 Recruitment Material_Privacy_C1071006_ FR_FR_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_9_Brochure Insert Part 2_BLT_C1071006_NL_NL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_9_MagnetisMM Program_Study Flyer_C1071006_DK_DA_Public | 4 |
| Recruitment arrangements (for publication) | K2_9_Recruitment Material_Brochure insert_C1071006_PL_PL_Public | 2 |
| Recruitment arrangements (for publication) | K2_9_Recruitment Material_Homepage_C1071006_CZ_CS_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_9_Video Postcard BLT_C1071006_GR_EL-EN_Public | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_About Clinical Trials_C1071006_AT_DE_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_About Clinical Trials_C1071006_DE_DE_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Referral letter_C1071006_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K3_1_Recruitment Material_Brochure Insert_C1071006_FR_FR_Public | 2 |
| Recruitment arrangements (for publication) | K3_2_Recruitment Material_Brochure Insert_C1071006_FR_EN_Public | 2 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_BMA Flyer_C1071006_AT_DE_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_BMA Flyer_C1071006_DE_DE_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_Use of Threewire_C1071006_ES_EN_Public | 1 |
| Recruitment arrangements (for publication) | K4_1_Massive Bio_Avis RGPD_C1071006_FR_FR | 2026.1 |
| Recruitment arrangements (for publication) | K4_2_Massive Bio_Conformite de la donnee RGPD_C1071006_FR_FR | 1 |
| Recruitment arrangements (for publication) | K4_3_Massive Bio_Formulaire de consentement_C1071006_FR_FR | 2026.1 |
| Recruitment arrangements (for publication) | K4_4_Massive Bio_Consentement RGPD_C1071006_FR_FR | 2026.1 |
| Recruitment arrangements (for publication) | K4_Recruitment Material_Patient Study Brochure_C1071006_AT_DE_Public | 4 |
| Recruitment arrangements (for publication) | K4_Recruitment Material_Study Flyer_C1071006_DE_DE_Public | 4 |
| Recruitment arrangements (for publication) | K5_Recruitment Material_Patient Study Brochure_C1071006_DE_DE_Public | 4 |
| Subject information and informed consent form (for publication) | L1 ICD_main_PART 1_C1071006_DE_DE_Public | 1 |
| Subject information and informed consent form (for publication) | L1_1 Main ICD Part 1_C1071006_IT_IT_Public | NA |
| Subject information and informed consent form (for publication) | L1_1 Main ICD Part 1_C1071006_NL_NL_Public | N/A |
| Subject information and informed consent form (for publication) | L1_1 Main ICD_C1071006_FI_FI_Public | N/A |
| Subject information and informed consent form (for publication) | L1_1 Main ICD-Part 1_C1071006_GR_EL_Public | 04.01.00 |
| Subject information and informed consent form (for publication) | L1_1_ICF_Main Part 2_C1071006_AT_DE_Public | 4 |
| Subject information and informed consent form (for publication) | L1_1_Main ICD Part 1_C1071006_ES_ES_Public | 2 |
| Subject information and informed consent form (for publication) | L1_1_Main ICD Part 1_C1071006_PL_PL_Public | 8 |
| Subject information and informed consent form (for publication) | L1_1_Main ICD Part 2_C1071006_DK_DA_Public | N/A |
| Subject information and informed consent form (for publication) | L1_1_Main ICD_Part1_C1071006_CZ_CS_Public | 15.0 |
| Subject information and informed consent form (for publication) | L1_1_Main ICD_Part1_C1071006_FR_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L1_3_ Main ICD_Part1_C1071006_FR_FR_TC | 2 |
| Subject information and informed consent form (for publication) | L1_c Main ICD_C1071006_BE_NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1a_1_ICF_Main Part 2_C1071006_BE_EN_Public | 3 |
| Subject information and informed consent form (for publication) | L1b_1_ICF_Main Part 2_C1071006_BE_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L2 ICD_Addendum main_PART1_C1071006_DE_DE_Public | 1 |
| Subject information and informed consent form (for publication) | L2 Main ICD Part 2_C1071006_PL_PL_Public | 5 |
| Subject information and informed consent form (for publication) | L2_1 Main ICD Part 2_C1071006_GR_EL_Public | 12.00.00 |
| Subject information and informed consent form (for publication) | L2_1 Main ICD Part 2_C1071006_NL_NL_Public | N/A |
| Subject information and informed consent form (for publication) | L2_1 Optional RRS_C1071006_FI_FI_Public | N/A |
| Subject information and informed consent form (for publication) | L2_1_ICF_Main Part 2_C1071006_ES_ES_Public | N/A |
| Subject information and informed consent form (for publication) | L2_1_ICF_Main Part 2_C1071006_FR_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L2_1_ICF_Prescreening_C1071006_AT_DE_Public | 5 |
| Subject information and informed consent form (for publication) | L2_1_Main ICD Part 2_C1071006_IT_IT_Public | NA |
| Subject information and informed consent form (for publication) | L2_1_Main ICD_Part2_C1071006_CZ_CS_Public | 16.0 |
| Subject information and informed consent form (for publication) | L2_1_Prescreen ICD_C1071006_DK_DA_Public | N/A |
| Subject information and informed consent form (for publication) | L2a_ICF_PPRIF_C1071006_BE_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L2b_ICF_PPRIF_C1071006_BE_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L2c_ICF_PPRIF_C1071006_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L3_1 Addendum ICD Part 1_C1071006_IT_IT_Public | NA |
| Subject information and informed consent form (for publication) | L3_1 PPRIF Part 1_C1071006_NL_NL_Public | 4 |
| Subject information and informed consent form (for publication) | L3_1 Prescreen ICD_C1071006_FI_FI_Public | N/A |
| Subject information and informed consent form (for publication) | L3_1_ICD Addendum Main ICD_C1071006_FR_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L3_1_ICD Addendum_C1071006_CZ_CS_Public | 9.0 |
| Subject information and informed consent form (for publication) | L3_1_ICD Addendum_C1071006_PL_PL_Public | 2 |
| Subject information and informed consent form (for publication) | L3_1_ICF_Main Part 2_C1071006_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L3_1_ICF_PPRIF_C1071006_AT_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L3_1_ICF_Prescreening_C1071006_ES_ES_Public | N/A |
| Subject information and informed consent form (for publication) | L3_1_PPRIF_C1071006_DK_DA_Public | NA |
| Subject information and informed consent form (for publication) | L3_ICD Addendum_C1071006_GR_EL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3a_1_ICF_Prescreening_C1071006_BE_EN_Public | 3 |
| Subject information and informed consent form (for publication) | L3b_1_ICF_Prescreening_C1071006_BE_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L3c_1_ICF_Prescreening_C1071006_BE_NL_Public | 3 |
| Subject information and informed consent form (for publication) | L4_1 ICD Optional-RRS_C1071006_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L4_1 PPRIF_C1071006_FI_FI_Public | N/A |
| Subject information and informed consent form (for publication) | L4_1_ICD Prescreening_C1071006_PL_PL_Public | 2 |
| Subject information and informed consent form (for publication) | L4_1_ICF_Optional RRS_C1071006_ES_ES_Public | N/A |
| Subject information and informed consent form (for publication) | L4_1_ICF_Prescreening_C1071006_DE_DE_Public | N/A |
| Subject information and informed consent form (for publication) | L4_1_ICF_Prescreening_C1071006_FR_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L4_1_Optional RRS_C1071006_CZ_CS_Public | 12.0 |
| Subject information and informed consent form (for publication) | L4_2_ICF_Prescreening_C1071006_FR_FR_TC | 3 |
| Subject information and informed consent form (for publication) | L4_PPRIF Part 2_C1071006_NL_NL_Public | 3 |
| Subject information and informed consent form (for publication) | L4a_Scout ICD_C1071006_BE_EN_Public | 2.0 |
| Subject information and informed consent form (for publication) | L4b_Scout ICD_C1071006_BE_FR_Public | 2.0 |
| Subject information and informed consent form (for publication) | L4c_Scout ICD_C1071006_BE_NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L5_1 Adult 16 and older Model ICF addendum_C1071006_NL_NL_Public | N/A |
| Subject information and informed consent form (for publication) | L5_1 ICD Prescreening_C1071006_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L5_1 PPRIF_C1071006_GR_EL_Public | N/A |
| Subject information and informed consent form (for publication) | L5_1_ICD Optional Procedure_C1071006_PL_PL_Public | 4 |
| Subject information and informed consent form (for publication) | L5_1_ICF_PPRF_C1071006_ES_ES_Public | N/A |
| Subject information and informed consent form (for publication) | L5_1_ICF_PPRIF_C1071006_DE_DE_Public | 2 |
| Subject information and informed consent form (for publication) | L5_1_ICF_PPRIF_C1071006_FR_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L5_EU Supplement_C1071006_FI_FI_Public | 1 |
| Subject information and informed consent form (for publication) | L5_Leaflet Rights of the subjects_C1071006_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L5_Optional RRS_Part2_C1071006_CZ_CS_Public_PLACEHOLDER | NA |
| Subject information and informed consent form (for publication) | L6 ICD PPRIF_C1071006_PL_PL_Public | 1 |
| Subject information and informed consent form (for publication) | L6_1 Optional RRS_Part 1_C1071006_FR_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L6_1 PPRIF_C1071006_IT_IT_Public | 3.0 |
| Subject information and informed consent form (for publication) | L6_1_ICD Addendum_C1071006_ES_ES_Public | 2 |
| Subject information and informed consent form (for publication) | L6_1_Prescreen ICD_C1071006_CZ_CS_Public | 8.0 |
| Subject information and informed consent form (for publication) | L6_2 Optional RRS_Part 1_C1071006_FR_FR_TC | 2 |
| Subject information and informed consent form (for publication) | L6_Scout ICD_C1071006_GR_EL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L6a Site Contact List_C1071006_DE_EN_Public | 1 |
| Subject information and informed consent form (for publication) | L7 ICD Scout_C1071006_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L7_1 Addendum Main ICD_Part 1_C1071006_FR_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L7_1 ICD Addendum_C1071006_GR_EL_Public | 02.01.00 |
| Subject information and informed consent form (for publication) | L7_1 Privacy Supplement_C1071006_IT_IT_Public | 3 |
| Subject information and informed consent form (for publication) | L7_1_ICD Addendum_C1071006_ES_ES_Public | N/A |
| Subject information and informed consent form (for publication) | L7_1_PPRIF_C1071006_CZ_CS_Public | 2.0 |
| Subject information and informed consent form (for publication) | L8_1 Addendum ICD Part 1_C1071006_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L8_1 Prescreening ICD_C1071006_GR_EL_Public | 05.00.00 |
| Subject information and informed consent form (for publication) | L8_1_ICD Addendum_C1071006_PL_PL_Public | NA |
| Subject information and informed consent form (for publication) | L8_1_ICF_Addendum Part 1_C1071006_FR_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L8_1_ICF_Addendum Part 1_PA9_C1071006_ES_ES_Public | N/A |
| Subject information and informed consent form (for publication) | L8_2_ICF_Addendum Part 1_C1071006_FR_FR | 1 |
| Subject information and informed consent form (for publication) | L8_EU Supplement_C1071006_CZ_CS_Public | 1 |
| Subject information and informed consent form (for publication) | L9_1 ICD Addendum Part I_C1071006_GR_EL_Public | 01.00.00 |
| Subject information and informed consent form (for publication) | L9_1_ICF_Addendum_PA9_C1071006_PL_PL_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SMPC_Daratumumab_EN_C1071006 | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SMPC_Dexamethasone_EN_C1071006 | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SMPC_Lenalidomide_EN_C1071006 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bortezomib_Velcade_C1071006_EN | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_Daratumumab_C1071006_EN_redline | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daratumumab_Compare 21Jan2025 to 27Oct2025_C1071006_EN | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Summary of Changes_Daratumumab_C1071006_EN | N/A |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_AT_DE_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_BE_FR_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_BE_NL_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_CZ_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_EN_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_ES_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_FR_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_GR_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_IT_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_NL_public | PA9 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_2024-514139-50-00_C1071006_PL_public | PA9 |
| Synopsis of the protocol (for publication) | D3_Protocol-Synopsis_2024-514139-50-00_C1071006_DE_public | PA9 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | Finland | Acceptable with conditions 2024-07-31
|
2024-07-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-25 | Finland | Acceptable 2025-02-10
|
2025-02-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-24 | Acceptable | 2025-03-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-13 | Acceptable | 2025-04-17 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-22 | 2025-04-22 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-15 | Finland | Acceptable 2025-10-20
|
2025-10-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-30 | Acceptable | 2025-11-13 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-07 | Acceptable | 2025-12-04 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-10 | Finland | Acceptable 2026-05-12
|
2026-05-12 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-18 | Acceptable 2026-05-12
|
2026-05-18 |