Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
386
Countries
7
Sites
14
Multiple myeloma (MM) with at least 2 prior therapies including an immunomodulatory (IMiD) compound and a proteasome inhibitor (PI) and demonstrated disease progression on or within 60 days of completion of the last therapy.
Compare the efficacy of bb2121 to standard regimens in subjects with RRMM as measured by progression-free survival (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
- 12 Jun 2019 → 13 Apr 2026
- Decision date (initial)
- 2024-06-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Celgene Corporation, United States
External identifiers
- EU CT number
- 2023-509848-10-00
- EudraCT number
- 2018-001023-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Therapy, Pharmacodynamic, Efficacy, Pharmacoeconomic
Compare the efficacy of bb2121 to standard regimens in subjects with RRMM as measured by progression-free survival (PFS)
Secondary objectives 6
- Evaluate the safety of bb2121 compared to standard regimens in subjects with RRMM
- Evaluate additional efficacy parameters of bb2121 compared to standard regimens in subjects with RRMM
- Characterize the expansion and persistence of chimeric antigen receptor (CAR) + T cells, in the peripheral blood (cellular kineticspharmacokinetics [PK])
- Evaluate the percentage of subjects who attain minimal residual disease (MRD) negative status by next generation sequencing (NGS)
- Evaluate the impact of bb2121 compared to standard regimens on the changes in health-related quality of life (HRQoL)
- Evaluate the impact of bb2121 on health utility values compared with standard regimens
Conditions and MedDRA coding
Multiple myeloma (MM) with at least 2 prior therapies including an immunomodulatory (IMiD) compound and a proteasome inhibitor (PI) and demonstrated disease progression on or within 60 days of completion of the last therapy.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 16.1 | HLT | 10028229 | Multiple myelomas | 10029104 |
| 21.1 | LLT | 10067095 | Multiple myeloma progression | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 13
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements within this protocol and for a subject randomized to Treatment Arm A, subject agrees to continued follow-up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.
- Subject has measurable disease, defined as: • M-protein (serum protein electrophoresis [sPEP] or urine protein electrophoresis [uPEP]): sPEP ≥ 0.5 g/dL or uPEP ≥ 200 mg/24 hours and/or • Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Subject has received at least 2 but no greater than 4 prior MM regimens. Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered as one regimen.
- Subject has received prior treatment with DARA, a proteasome inhibitor- and an immunomodulatory compound-containing regimen for at least 2 consecutive cycles.
- Subject must be refractory to the last treatment regimen. Refractory is defined as documented progressive disease during or within 60 days (measured from the last dose of any drug within the regimen) of completing treatment with the last anti-myeloma regimen before study entry.
- Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 peripheral neuropathy.
- Adequate vascular access for leukapheresis.
- Adequate contraceptive measures as outlined in the protocol.
- Only subjects that would be considered for any of the 5 proposed standard regimens (DPd, DVd, IRd, Kd or EPd), as judged by the Investigator, should be included in the study.
Exclusion criteria 17
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has nonsecretory MM.
- Subject has any of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) < 1,000/μL b. Platelet count: < 75,000/μL in subjects in whom < 50% of bone marrow nucleated cells are plasma cells and platelet count < 50,000/μL in subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells (it is not permissible to transfuse a subject to reach this level) c. Hemoglobin < 8 g/dL (< 4.9 mmol/L) (it is not permissible to transfuse a subject to reach this level) d. Serum creatinine clearance (CrCl) < 45 mL/min e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) f. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN) g. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome h. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
- Subject has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air.
- Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies: • Basal cell carcinoma of the skin • Squamous cell carcinoma of the skin • Carcinoma in situ of the cervix • Carcinoma in situ of the breast • Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) or prostate cancer that can be treated with curative intent
- Subject has active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
- Subject with known central nervous system (CNS) involvement with myeloma.
- Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation.
- Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal. Note that forced expiratory testing (FEV1) is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is < 50% of predicted normal.
- Subject has a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- Subject was treated with DARA in combination with POM with or without dexamethasone (DP±d) as part of their most recent antimyeloma treatment regimen, cannot receive DPd as bridging therapy but may receive DVd , IRd, Kd or EPd as bridging as per Investigator's discretion if randomized to Treatment Arm A.
- Subject was treated with DP±d as part of their most recent antimyeloma treatment regimen, cannot receive DPd if randomized to Treatment Arm B but may receive DVd, IRd, Kd or EPd as per Investigator's discretion.
- Subject was treated with DARA in combination with BTZ with or without dexamethasone (DV±d) as part of their most recent antimyeloma treatment regimen, cannot receive DVd as bridging therapy but may receive DPd, IRd, Kd or EPd as bridging as per Investigator's discretion if randomized to Treatment Arm A.
- Subject was treated with DV±d as part of their most recent antimyeloma treatment regimen, cannot receive DVd if randomized to Treatment Arm B but may receive DPd, IRd, Kd or EPd as per Investigator's discretion.
- Subject was treated with IXA in combination with LEN with or without dexamethasone (IR±d) as part of their most recent antimyeloma treatment regimen, cannot receive IRd as bridging therapy but may receive DPd, DVd, Kd or EPd as bridging as per Investigator's discretion if randomized to Treatment Arm A. Refer to protocol for additional exclusion criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival (PFS)
Secondary endpoints 12
- Overall Response Rate (ORR)
- Overall Survival (OS)
- Event-free Survival (EFS)
- Minimal Residual Disease (MRD)
- Complete Response (CR) Rate
- Duration of Response (DOR)
- Time to Response (TTR)
- Safety
- Pharmacokinetics (PK) – bb2121
- Primary Domains of Interest Health Related Quality of Life (HRQoL)
- Time to next anti-myeloma treatment
- Progression-free survival after next line therapy (PFS2)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10519004 · Product
- Active substance
- Idecabtagene Vicleucel
- Pharmaceutical form
- CELL SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 450 Other
- Max total dose
- 450 Other
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/17/1863
Comparator 18
Dexamethason CF 20 mg/ml, injectievloeistof
PRD502494 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- RVG 55091
- MA holder
- CENTRAFARM B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Tablets BP 2.0mg
PRD3570594 · Product
- Active substance
- Dexamethasone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 39699/0056
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12558803 · ATC
- Active substance
- Elotuzumab
- Substance synonyms
- HULUC63, BMS901608
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 20 mg/kg milligram(s)/kilogram
- Max total dose
- 999 mg/kg milligram(s)/kilogram
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC23 — ELOTUZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264287 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/008
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(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
- No
PRD9264271 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(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
- No
Kyprolis 30 mg powder for solution for infusion
PRD4519869 · Product
- Active substance
- Carfilzomib
- Substance synonyms
- PR-171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 56 mg/m2 milligram(s)/square meter
- Max total dose
- 999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/003
- MA holder
- AMGEN EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD4091122 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 16 mg/kg milligram(s)/kilogram
- Max total dose
- 999 mg/kg milligram(s)/kilogram
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB121332 · Substance
- Active substance
- Ixazomib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP15688202 · ATC
- Active substance
- Ixazomib Citrate
- Substance synonyms
- MLN9708, 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid, MLN-9708
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG03 — IXAZOMIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB121332 · Substance
- Active substance
- Ixazomib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VELCADE 3.5 mg powder for solution for injection
PRD703624 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Max daily dose
- 1.3 mg/m2 milligram(s)/square meter
- Max total dose
- 999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260808 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical supplies product (CC-4047 4mg capsules), refer to Simplified IMPD for details
PRD9260804 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical supplies product (CC-4047 1mg capsules) , refer to Simplified IMPD for details
PRD9260805 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical supplies product (CC-4047 2mg capsules), refer to Simplified IMPD for details
PRD9260806 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 72 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical supplies product (CC-4047 3mg capsules), refer to Simplified IMPD for details
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 7
| Organisation | City, country | Duties |
|---|---|---|
| Cellcarta Fremont LLC ORG-100042774
|
Fremont, United States | Other |
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Code 12, Code 13, Other |
| Cerba Research ORG-100042694
|
Gent, Belgium | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
Locations
7 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 7 | 1 |
| France | Ended | 47 | 4 |
| Germany | Ended | 20 | 3 |
| Italy | Ended | 17 | 1 |
| Netherlands | Ended | 12 | 2 |
| Norway | Ended | 9 | 1 |
| Spain | Ended | 26 | 2 |
| Rest of world
United States, Japan, Switzerland, Canada, United Kingdom
|
— | 248 | — |
Investigational sites
Institut Universitaire Du Cancer Toulouse-Oncopole
Bureau des Essais Cliniques, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nantes
Service d’Hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Service d’Hématologie, Rue Michel Polonowski, 59000, Lille
Assistance Publique Hopitaux De Paris
Service Immuno-Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Heidelberg AöR
Klinik für Hämatologie, Onkologie und Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Unità Operativa di Ematologia, Via Pietro Albertoni 15, 40138, Bologna
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 |
|---|---|---|---|---|---|
| Belgium | 2019-08-14 | 2026-01-23 | 2019-09-20 | 2021-03-19 | |
| France | 2019-10-04 | 2026-03-27 | 2019-10-21 | 2021-06-17 | |
| Germany | 2019-12-18 | 2026-03-18 | 2020-03-03 | 2021-07-28 | |
| Italy | 2019-09-10 | 2026-03-19 | 2019-09-23 | 2021-07-16 | |
| Netherlands | 2020-02-06 | 2026-04-01 | 2020-05-26 | 2021-06-04 | |
| Norway | 2019-12-05 | 2026-01-29 | 2020-01-07 | 2021-06-07 | |
| Spain | 2019-06-12 | 2026-03-06 | 2019-06-17 | 2021-07-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 83 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Admin letter_2023-509848-10-00_Redacted | NA |
| Protocol (for publication) | D1_Protocol_2023-509848-10-00_Redacted | 6 |
| Protocol (for publication) | D1_Protocol_Risk-Benefit_2023-509848-10-00_Redacted | 05 |
| Protocol (for publication) | D4_Patient facing questionnaire_Redaction statement | NA |
| Recruitment arrangements (for publication) | K1_Recruit arrang_blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit arrang_Blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit arrang_blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit arrang_blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit arrang_blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_blank_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_statement_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_statement_FP | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Annex to Main (Risks Drugs)_en_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Annex to Main (Risks Drugs)_fr_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Annex to Main (Risks Drugs)_nl_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Exceptional Release_en_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Exceptional Release_fr_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Exceptional Release_nl_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Female Patient_en_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Female Patient_fr_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Female Patient_nl_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_en_FP | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_fr_FP | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_nl_FP | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_en_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_fr_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_nl_FP | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Annex to Main ICF_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Autopsy_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Future Res_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Exception Release_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Exception Release_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Exception-release_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Exceptional release_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Exceptional Release_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Female patient_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Female Patient_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Female subject pregnancy_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_HIP Exc release_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_HIP Partner_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_HIP Pregnant Female Partner_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main ICF addendum procedures_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main ICF_FP | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 10 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 8 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Partner Consent_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Female_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant partner_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Subject_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy Form_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Regional SIS-ICF Addendum_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Risks Addendum_FP | 10.0 |
| Subject information and informed consent form (for publication) | L2_EQ-5D-5L questionnaire_en_FP | N/A |
| Subject information and informed consent form (for publication) | L2_EQ-5D-5L questionnaire_fr_FP | N/A |
| Subject information and informed consent form (for publication) | L2_EQ-5D-5L questionnaire_nl_FP | N/A |
| Subject information and informed consent form (for publication) | L2_MMSE questionnaire_en_FP | N/A |
| Subject information and informed consent form (for publication) | L2_MMSE questionnaire_fr_FP | N/A |
| Subject information and informed consent form (for publication) | L2_MMSE questionnaire_nl_FP | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Darzalex_FP | 26 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dexamethasone 2mg_FP | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dexamethasone CF 20mgml_FP | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Empliciti_FP | 13 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kyprolis_FP | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ninlaro_clean | 20 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Velcade_FP | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-509848-10-00_EN | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEde_2023-509848-10_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEfr_2023-509848-10_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEnl_2023-509848-10_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ESes_2023-509848-10_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FRfr_2023-509848-10_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ITit_2023-509848-10_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NLnl_2023-509848-10_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NOno_2023-509848-10_FP | 1.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-30 | France | Acceptable 2024-06-10
|
2024-06-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-21 | France | Acceptable 2024-06-10
|
2024-08-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-27 | France | Acceptable 2025-01-08
|
2025-01-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-15 | France | Acceptable 2025-01-08
|
2025-04-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-14 | France | Acceptable 2025-11-24
|
2025-11-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-20 | France | Acceptable 2026-03-09
|
2026-03-11 |