Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
170
Countries
5
Sites
11
Multiple Myeloma
To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jan 2020 → ongoing
- Decision date (initial)
- 2024-03-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506587-13-00
- EudraCT number
- 2018-004124-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Pharmacogenetic, Others, Safety, Pharmacodynamic
To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528
Conditions and MedDRA coding
Multiple Myeloma
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
| EU CT number | Title | Sponsor |
|---|---|---|
| 2018-004124-10 | A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma , Estudio de fase 2 de múltiples cohortes, abierto, de JNJ-68284528, una terapia de linfocitos T con receptor de antígeno quimérico (T-CAR) dirigidos frente a BCMA en sujetos con mieloma múltiple |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Cohort A: -1-3 prior lines of therapy, including PI and IMiD -Lenalidomide refractory -Anti-CD38 mAb exposure not required -PD per IMWG criteria ≤6 months of last regimen; confirmation may be either central or local -Prior SCT allowed (allo: >6 months before apheresis; auto: >12 weeks before apheresis)
- Cohort B: -Frontline therapy with PI and IMiD -Transplant and non-transplant patients -Anti-CD38 mAb exposure not required -PD per IMWG criteria ≤12 months of: a. Autologous SCT b. Start of initial therapy (non-transplanted patients)
- Cohort C: -Previously treated with PI, IMiD, anti-CD38 mAb and BCMA-directed therapy (as monotherapy or in combination) a. Irrespective of dose level or response to prior BCMA-directed therapy -PD per IMWG criteria a. ≤12 months of last line of therapy b. ≤6 months of prior therapy, and refractory or non-responsive to their most recent line of therapy
- Cohort A, B, C: Measurable disease at Screening as defined by any of the following: -Serum M-protein ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or -Light chain MM without measurable disease in serum or urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio -Central screening lab results required for all study patients: Local laboratory assessments may be used to establish measurable disease at Screening, with local laboratory result ≥125% of requirements -For subjects with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. -Lab values as defined in the protocol
- Cohort D: -Newly diagnosed MM per IMWG with 4 to 8 total cycles of initial therapy, including induction, high-dose therapy and ASCT with or without consolidation a. Previously treated for smoldering myeloma not eligible b. Patient treated with consolidation must have received ≤2 cycles - Received IMiD or PI or both in combination with steroid as part of induction or consolidation regimen -Tx with alkylating therapy (eg, cyclophosphamide) or mAb during induction/ consolidation permitted -Labs as specified in the protocol -women of childbearing potential must follow the contraception criteria outlined in the local global REVLIMID® pregnancy prevention program or equivalent local Risk Evaluation and Mitigation Strategy (REMS), whichever is more stringent, as applicable in their region. -Men should agree to practice contraception according to and for the time frame specified in the local global REVLIMID® pregnancy prevention program or equivalent local REMS, whichever is more stringent, as applicable in their region.
- Cohort E: -Measurable disease at Screening - Documented diagnosis of MM according to IMWG criteria -Labs as specified in the protocol
- Cohort F: - Documented new diagnosis of multiple myeloma according to IMWG diagnostic criteria. - Multiple myeloma classified as standard risk per International Staging System (ISS) stage I or II disease criteria - Received initial therapy as specified in protocol. Acceptable combinations include: a. daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd) or b. daratumumab, lenalidomide and dexamethasone (D-Rd) or c. a carfilzomib-based triplet or quadruplet regimen - Patient must have a documented efficacy response of VGPR or better, without Progressive Disease prior to enrollment, as assessed per IMWG 2016 criteria. - ECOG Performance Status grade of 0 or 1. For a full list of inclusion criteria, please refer to the protocol
Exclusion criteria 4
- Key Exclusion criteria (All cohorts): -Antitumor treatment washout prior to apheresis -Toxicity from previous anticancer therapy must have resolved to baseline or ≤Grade 1 except alopecia or peripheral neuropathy - Serious underlying medical condition, eg: a.Clinically significant cardiac conditions (CHF, MI, LVEF <45%) b. Active / Hx of autoimmune disease within 3 yrs c. Dementia or altered mental status d. Serious viral, bacterial or uncontrolled systemic fungal infection e. Seropositive for HIV f. Clinically significant Hepatitis B or C infection - Cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone ≤7 days prior to apheresis - Stroke or seizure ≤6 months - Pregnant, breast-feeding or planning to become pregnant / father child while enrolled in study and until 1 year after receiving a JNJ-68284528 infusion - Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, or JNJ-68284528 or its excipients, including DMSO (refer to Investigator's Brochure).
- Cohort D: -Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study and until 1 year after receiving a JNJ-68284528 infusion or for 4 weeks following discontinuation of lenalidomide (whichever is later). -Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, lenalidomide, or JNJ68284528 or its excipients, including DMSO (refer to Investigator's Brochure).
- Cohort E: Contraindications, known life threatening allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies or human proteins, cyclophosphamide, fludarabine, lenalidomide, daratumumab, bortezomib, dexamethasone, or JNJ-68284528 excipients, including DMSO. -Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study and until: 1 year after receiving a JNJ-68284528 infusion, or for 4 weeks following discontinuation of lenalidomide, or until 3 months after daratumumab (whichever is later). -Plans to father a child while enrolled in this study until: 1 year after receiving a JNJ-68284528 infusion, or for 4 weeks following discontinuation of lenalidomide, or until 3 months after daratumumab (whichever is later).
- Cohort F: - Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. - Prior therapy, prior to apheresis - Received a cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone within the 7 days prior to apheresis - Ongoing toxicity from previous anticancer therapy must have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy. - Major surgery within 2 weeks prior to apheresis, or surgery planned after apheresis up to 2 weeks after cilta-cel administration. For a full list of exclusion criteria, please refer to the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- MRD negative rate (10-5 threshold) as defined by the International Myeloma Working Group (IMWG) criteria using next generation sequencing (NGS) or next generation flow (NGF)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 15
Lenalidomide Accord 25 mg hard capsules
PRD6773401 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/011
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 10 mg hard capsules
PRD6773396 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/006
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 20 mg hard capsules
PRD6773400 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/010
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 5 mg hard capsules
PRD6773394 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/004
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 15 mg hard capsules
PRD6773399 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/009
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 25 mg hard capsules
PRD9244619 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/014
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 15 mg hard capsules
PRD6773398 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/008
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 10 mg hard capsules
PRD6773397 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/007
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 20 mg hard capsules
PRD9244618 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/013
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 5 mg hard capsules
PRD6773393 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 25 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/003
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10873169 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
PRD11008250 · Product
- Active substance
- Ciltacabtagene Autoleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 Kg kilogram(s)
- Max total dose
- 0 Kg kilogram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2252
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 112 Day(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
Dexamethasone Tablets BP 2.0mg
PRD3570594 · Product
- Active substance
- Dexamethasone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 112 Day(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
VELCADE 3.5 mg powder for solution for injection
PRD703624 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 84 Day(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
Auxiliary 2
—
SCP146752 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Endoxana Injection 1000 mg Powder for Solution for Injection
PRD6868166 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PA 2299/027/002
- MA holder
- BAXTER HOLDING B.V.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Cellex Collection Center GmbH ORG-100020568
|
Cologne, Germany | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Ancillare LP ORG-100044089
|
Horsham, United States | Other |
| Parexel International Corp. ORG-100007310
|
Durham, United States | Data management |
| Smithers PDS LLC ORG-100040403
|
Gaithersburg, United States | Laboratory analysis |
| Charles River Laboratories International Inc. ORG-100041066
|
Mattawan, United States | Laboratory analysis |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Integris Bioservices LLC ORG-100049056
|
Lower Gwynedd, United States | Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Cerba Research ORG-100042694
|
Gent, Belgium | Laboratory analysis |
Locations
5 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 15 | 2 |
| France | Ended | 6 | 3 |
| Germany | Ongoing, recruitment ended | 3 | 2 |
| Netherlands | Ongoing, recruitment ended | 10 | 2 |
| Spain | Ongoing, recruitment ended | 22 | 2 |
| Rest of world
Israel, Saudi Arabia, United States
|
— | 114 | — |
Investigational sites
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Centre Hospitalier Universitaire De Nantes
Service d'hématologie clinique, 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 Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75010, Paris
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistr. 52, 20246 Hamburg, Martinistrasse 52, Eppendorf, Hamburg
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 | 2020-01-30 | 2020-02-13 | 2022-10-13 | ||
| France | 2020-08-21 | 2025-03-20 | 2020-09-25 | 2022-04-29 | |
| Germany | 2021-07-26 | 2022-04-11 | 2023-01-10 | ||
| Netherlands | 2020-06-16 | 2020-06-24 | 2022-09-16 | ||
| Spain | 2020-03-04 | 2020-03-11 | 2022-09-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 102 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED Protocol 2023-506587-13 | Am7-EEA-2 |
| Protocol (for publication) | D4_PF_EORTC QLQ-C30_ Placeholder | NA |
| Protocol (for publication) | D4_PF_PRO-CTCAE_Placeholder | NA |
| Protocol (for publication) | D4_Redacted_PF_MySIm-Q_Combined EN NL FR DE | NA |
| Protocol (for publication) | D4_Redacted_PF_PGIC_Combined_ EN NL FR DE | NA |
| Protocol (for publication) | D4_Redacted_PF_PGIS_Combined EN NL FR DE | NA |
| Recruitment arrangements (for publication) | K1_Placeholder Document_Recruitment Arrangements_DE_EN_68284528MMY2003 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment arrangements_FR_EN_68284526MMY2003 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Placeholder_BE_en_68284528MMY2003 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Placeholder_NL_en_68284528MMY2003 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arrangements_ES_EN_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_NL_nl_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2 cohort A-C and F_DE_GER_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2 cohort E_DE_GER_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2_BE_en_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2_BE_fr_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2_BE_nl_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_Addendum 1 cohort A-C and F_DE_GER_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_Addendum 1 cohort E_DE_GER_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_BE_dut_2023-506587-13 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_BE_fre_2023-506587-13 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Cohorts ABCF_ES_RUS_2023-506587-13 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 5_BE_Dut_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 5_BE_Fre_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 5_NL_Dut_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 6_BE_Dut_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 6_BE_Fre_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 6_NL_Dut_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Cohort D_ES_ES_68284528MMY2003 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Cohort E_ES_ES_68284528MMY2003 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Cohorts ABCF_ES_ES_68284528MMY2003 | 14 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner Cohort D_ES_ES_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner Cohort E_ES_ES_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner Cohorts ABCF_ES_ES_68284528MMY2003 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient Cohort D_ES_ES_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient Cohort E_ES_ES_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient Cohorts ABCF_ES_ES_68284528MMY2003 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal Cohort D_ES_ES_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal Cohort E_ES_ES_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal Cohorts ABCF_ES_ES_68284528MMY2003 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ABCF Cohorts Addendum 3_FR_FRE_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_NL_dut_2023-506587-13 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_NL_en_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_NL_nl_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_D Cohort Addendum 3_FR_FRE_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_D Cohort Addendum 4_FR_FRE_2023-506587-13 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF cohort E_DE_GER_68284528MMY2003 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF cohorts A_B_C_F_DE_GER_68284528MMY2003 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF future research_DE_GER_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_ABCF Cohorts_Addendum 1_FR_FR_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_ABCF Cohorts_Addendum 2_FR_FR_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_ABCF Cohorts_FR_FR_68284528MMY2003 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_D Cohort_Addendum 1_FR_FR_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_D Cohort_Addendum 2_FR_FR_68284528MMY2003 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_D Cohort_FR_FR_68284528MMY2003 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN-Cohort ABCF_NL_en_68284528MMY2003 | 6.5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN-Cohort ABCF_NL_nl_68284528MMY2003 | 6.5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN-Cohort D_NL_en_68284528MMY2003 | 6.5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN-Cohort D_NL_nl_68284528MMY2003 | 6.5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN-Cohort E_NL_en_68284528MMY2003 | 3.3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN-Cohort E_NL_nl_68284528MMY2003 | 3.3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Cohorts ABCF_ES_RUS_2023-506587-13 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_pregnant partner ICF cohort E_DE_GER_68284528MMY2003 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_pregnant partner ICF cohorts A_B_C_DE_GER_68284528MMY2003 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_ABCF Cohorts_FR_FR_68284528MMY2003 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_D Cohort_FR_FR_68284528MMY2003 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort ABCF_BE_en_68284528MMY2003 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort ABCF_BE_fr_68284528MMY2003 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort ABCF_BE_nl_68284528MMY2003 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort D_BE_en_68284528MMY2003 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort D_BE_fr_68284528MMY2003 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort D_BE_nl_68284528MMY2003 | 6.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort E_BE_en_68284528MMY2003 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort E_BE_fr_68284528MMY2003 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Cohort E_BE_nl_68284528MMY2003 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort ABCF_BE_dut_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort ABCF_BE_fre_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort ABCF_NL_dut_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort D_BE_dut_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort D_BE_fre_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort D_NL_dut_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort E_BE_dut_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort E_BE_fre_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF-Pregnant Partner-Cohort E_NL_dut_2023-506587-13 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card ABCF_ES_RUS_2023-506587-13 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card ABCF_ES_SPA_ 2023-506587-13 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card D_ES_SPA_ 2023-506587-13 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card E_ES_SPA_ 2023-506587-13 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ABCF Cohort_FR_FR_68284528MMY2003 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_cohort A-B-C-F_DE_GER_2023-506587-13 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_cohort E_DE_GER_2023-506587-13 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_D Cohort_FR_FR_68284528MMY2003 | 9 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Dexamethasone 2mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Dexamethasone 4mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Lenalidomide | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Velcade | NA |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_de_2023-506587-13 | Am7-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_fr_2023-506587-13 | Am7-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_nl_2023-506587-13 | Am7-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_ES_2023-506587-13 | Am7 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FR_2023-506587-13 | Am7-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_nl_2023-506587-13 | Am7-EEA2 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | Belgium | Acceptable 2024-03-05
|
2024-03-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-01 | Belgium | Acceptable 2024-10-01
|
2024-10-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-11 | Belgium | Acceptable 2025-05-05
|
2025-05-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-13 | Belgium | Acceptable 2025-08-28
|
2025-08-28 |