Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
17
Countries
6
Sites
13
Cancer
Master Protocol and Substudy 01: • Part 1 (dose finding, experimental substudies) (Master only): -To determine or confirm the recommended dose of novel agents when combined with isatuximab with or without dexamethasone in participants with RRMM. • Part 2 (expansion, controlled experimental substudies): -To demonstra…
Key facts
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 Mar 2021 → ongoing
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514988-25-00
- EudraCT number
- 2020-003024-16
- WHO UTN
- U1111-1310-5186
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy, Efficacy, Pharmacokinetic, Safety
Master Protocol and Substudy 01:
• Part 1 (dose finding, experimental substudies) (Master only):
-To determine or confirm the recommended dose of novel agents when combined with isatuximab with or without dexamethasone in participants with RRMM.
• Part 2 (expansion, controlled experimental substudies):
-To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of rate of very good partial response (VGPR) or better.
• Part 2 (expansion, independent experimental substudies):
-To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of overall response rate (ORR).
Secondary objectives 12
- To assess ORR in each treatment arm -ORR in Part 1 (dose finding, experimental substudies)- Master only and Part 2 (expansion, controlled experimental substudies).
- VGPR in Part 1 (dose finding, experimental substudies)- Master only and Part 2 (expansion, independent experimental substudies).
- To assess the clinical benefit rate (CBR) in each treatment arm.
- To assess the duration of response (DOR) in each treatment arm.
- To assess the time to first response (TT1R) in each treatment arm.
- To assess the time to best response (TTBR) in each treatment arm.
- To assess safety and tolerability in each treatment arm.
- To assess progression free survival (PFS) in each treatment arm.
- To assess overall survival (OS) in each treatment arm.
- To evaluate the potential immunogenicity of isatuximab and novel agents when applicable.
- To characterize the PK of isatuximab and novel agents.
- To assess disease and treatment related symptoms, cancer and disease specific health-related quality of life, global impact of side effects and confirm/establish clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores - Part 1 (dose optimization,independent and controlled experimental substudies) and Part 2 (expansion, independent and controlled experimental substudies).
Conditions and MedDRA coding
Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | PT | 10081847 | Plasma cell myeloma refractory | 100000004864 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002205-PIP01-17
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514990-23-00 | Phase 1/2 trial evaluating isatuximab in combination with pegenzileukin in relapsed or refractory multiple myeloma (RRMM) previously exposed to anti-CD38 and anti-BCMA | Sanofi-Aventis Recherche & Developpement |
| 2024-514993-38-00 | Phase 1/2 trial evaluating isatuximab in combination with evorpacept and dexamethasone in relapsed or refractory multiple myeloma (RRMM) | Sanofi-Aventis Recherche & Developpement |
| 2024-514989-40-00 | Phase 1/2 trial evaluating isatuximab in combination with belantamab mafodotin and dexamethasone in relapsed or refractory multiple myeloma (RRMM) | Sanofi-Aventis Recherche & Developpement |
| 2024-514992-16-00 | Phase 1/2 trial evaluating isatuximab in combination with SAR445761 (belumosudil) and dexamethasone in relapsed or refractory multiple myeloma (RRMM) | Sanofi-Aventis Recherche & Developpement |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Participant must be 18 years of age inclusive or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is considered one line).
- RRMM with measurable disease: -Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- RRMM with measurable disease:-Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
- RRMM with measurable disease:-Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria (serum Ig free light chain ≥10 mg/dL and abnormal serum Ig kappa lambda free light chain ratio <0.26 or >1.65).
- Men or woman or childbearing potential should agree to use contraception.
- Substudy 01: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 12 months after the last dose. “Exposure” is defined as at least 2 cycles of therapy.
Exclusion criteria 20
- Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma.
- Uncontrolled infection within 14 days prior to first study intervention administration.
- Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to first study intervention administration., eg, myocardial infarction, unstable angina, coronary (eg, coronary artery bypass graft, percutaneous coronary intervention) or peripheral artery revascularization, left ventricular ejection fraction <40%, heart failure New York Heart Association Classes III and IV, stroke, transient ischemic attack, pulmonary embolism, other thromboembolic event, or cardiac arrhythmia (Grade 3 or higher by NCI CTCAE Version 5.0).
- Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A.
- Uncontrolled or active hepatitis B virus (HBV) infection.
- Active hepatitis C virus (HCV) infection.
- Any of the following within 3 months prior to first study intervention administration: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease
- Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma, unless they are successfully treated with curative intent for more than 3 years before first study intervention administration.
- Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone.
- Participants with a contraindication to treatment.
- Vaccination with a live vaccine 4 weeks before the start of the study.
- Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Hemoglobin <8 g/dL.
- Platelets <50 × 10^9/L.
- Absolute neutrophil count <1.0 × 10^9/L.
- Creatinine clearance <30 mL/min/1.73m2
- Total bilirubin >1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN.
- Aspartate aminotransferase and/or alanine aminotransferase >3 × ULN.
- Patients with grade 3 or 4 hypercalcemia.
- Substudy 01:Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab- Master only
- Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)
- Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies
Secondary endpoints 17
- Part 1 (dose finding, experimental substudies): ORR – Master only
- Part 2 (expansion, controlled experimental substudies): ORR
- Part 1 (dose finding, experimental substudies): VGPR or better – Master only
- Part 2 (expansion, independent experimental substudies): VGPR or better
- Clinical Benefit Rate (CBR) in each treatment arm
- Duration of Response (DOR) in each treatment arm
- Time to First Response (TT1R) in each treatment arm
- Time to Best Response (TTBR) in each treatment arm
- Number of participants with treatment emergent adverse events and serious adverse events in each treatment arm
- Progression-free survival (PFS) in each treatment arm
- Overall Survival (OS) in each treatment arm
- Immunogenicity of isatuximab and novel agents
- Concentration of novel agents (experimental arms) and isatuximab (Ctrough)
- Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
- Disease and treatment-related quality of life will be assessed using the EORTC multiple myeloma module (QLQ-MY20) questionnaire
- Global impact of side effects will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) (GP5)
- Estimate/Confirm established clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores using the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 20
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- 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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD988427 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.02.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD10652636 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10653334 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
Pomalidomide Adalvo 1 mg hard capsules
PRD11984093 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- OCULAR USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02201
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Adalvo 4 mg hard capsules
PRD11984096 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02204
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Adalvo 2 mg hard capsules
PRD11984094 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02202
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pomalidomide Adalvo 3 mg hard capsules
PRD11984095 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- MA1339/02203
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260808 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- 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
- No
PRD9260810 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/006
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260805 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- 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
- No
PRD9260809 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/005
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260813 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/007
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260814 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/008
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260806 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- 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
- No
PRD9260804 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- 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
- No
PRD10978237 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10978287 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10978187 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10978182 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 82 Avenue Raspail
- City
- Gentilly
- Postcode
- 94250
- Country
- France
Scientific contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Public contact point
- Organisation
- Sanofi-Aventis Recherche & Developpement
- Contact name
- Clinical Sciences and Operations
Third parties 14
| Organisation | City, country | Duties |
|---|---|---|
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Valencia, United States | Laboratory analysis |
| CellCarta Biosciences ORG-100039314
|
Charleroi, Belgium | Laboratory analysis |
| Depo-pack S.r.l. ORG-100013780
|
Saronno, Italy | Code 14 |
| Labcorp Early Development Laboratories Limited ORG-100011365
|
Harrogate, United Kingdom | Laboratory analysis |
| Cellcarta Pty Limited ORG-100042914
|
Norwest, Australia | Laboratory analysis |
| Endpoint Clinical Inc. ORG-100040567
|
San Francisco, United States | Interactive response technologies (IRT) |
| ESMS Global Limited ORG-100023149
|
London, United Kingdom | Other |
| Azenta US Inc. ORG-100012907
|
South Plainfield, United States | Other |
| Mosaic Laboratories LLC ORG-100042385
|
Lake Forest, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Cellcarta Biosciences Inc. ORG-100042227
|
Montreal, Canada | Laboratory analysis |
Locations
6 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 1 | 4 |
| Germany | Ongoing, recruiting | 1 | 2 |
| Greece | Ongoing, recruiting | 2 | 2 |
| Italy | Ongoing, recruiting | 1 | 2 |
| Norway | Ongoing, recruiting | 1 | 1 |
| Portugal | Ended | 1 | 2 |
| Rest of world
Israel, United States, Korea, Republic of, Australia
|
— | 10 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Service d'Hematologie, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Service d'Hematologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
Service Hematologie adultes, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire De Lille
Service des maladies du sang, Rue Michel Polonowski, 59000, Lille
Universitaetsklinikum Frankfurt AöR
Universitatsklinikum Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Schleswig-Holstein AöR
Hamatologie/Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Alexandra Hospital
Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Evangelismos S.A.
Department of Hematology and Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
I R S T Dipartimento Di Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dip di Med.Specialistica, Diagnostica e Sperimentale-Unita Operativa di Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Unidade Local De Saude De Coimbra E.P.E.
Centro Hospitalar e Universitario de Coimbra, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Gaia/Espinho E.P.E.
Centro Hospitalar Vila Nova Gaia-Espinho EPE, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
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 |
|---|---|---|---|---|---|
| France | 2021-03-31 | 2021-03-31 | |||
| Germany | 2024-09-04 | 2024-09-04 | |||
| Greece | 2021-05-17 | 2021-05-17 | |||
| Italy | 2021-11-23 | 2021-11-23 | |||
| Norway | 2022-09-12 | 2022-09-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 76 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1-rdct-protocol-SS01-el-2024-514988-25 | 10 |
| Protocol (for publication) | d1-rdct-protocol-SS01-en-2024-514988-25 | 10 |
| Protocol (for publication) | d4-patient-facing-material-list for publication-en-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIC-RRMM-de-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIC-RRMM-el-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIC-RRMM-en-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIC-RRMM-fr-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIC-RRMM-it-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIC-RRMM-no-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIC-RRMM-pt-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIS-RRMM-de-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIS-RRMM-el-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIS-RRMM-en-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIS-RRMM-fr-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIS-RRMM-it-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIS-RRMM-no-2024-514988-25 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PGIS-RRMM-pt-2024-514988-25 | 1 |
| Protocol (for publication) | d5-rdct-master-protocol-el-2024-514988-25 | 10 |
| Protocol (for publication) | d5-rdct-master-protocol-en-2024-514988-25 | 10 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-fr | 4 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-pt | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-SS01-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-ss01-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-ss01-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-SS01-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-ss01-en | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-SS01-fr | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-statement-en | 1 |
| Recruitment arrangements (for publication) | K2-recruitment-material-dr-to-dr-referral-letter-it | 1 |
| Recruitment arrangements (for publication) | K2-recruitment-material-urine-collection-leaflet-fr | 1 |
| Subject information and informed consent form (for publication) | L1-redacted-sis-icf-substudy01-activity-plan-no | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-child-follow-up-fr | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-direct-to-patient-el | 3.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-follow-up-pregnancy-father-partner-fr | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-follow-up-pregnancy-mother-partner-fr | 6 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future-use-el | 7.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-futureuse-subst01-de | 3.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-screening-it | 7.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-substudy01-el | 5.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-biological-samples-el | 5.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-optional-saliva-el | 4.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-el | 6.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-it | 6 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-no | 4 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-pt | 6.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-subst01-de | 7 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-screening-de | 10 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-subst01-de | 7 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-it | 5.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-screening-el | 7.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-screening-no | 6 |
| Subject information and informed consent form (for publication) | L1-sis-icf-screening-patient-fr | 7 |
| Subject information and informed consent form (for publication) | L1-sis-icf-screening-pt | 6.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-SS01-it | 5.3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-SS01-pt | 4.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-sub-study01-patient-fr | 6 |
| Subject information and informed consent form (for publication) | L1-sis-icf-substudy-01-no | 5 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-confidentality-release-de | 1.0 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-gpletter-it | 9.0 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-patient-pomalidomid-info-de | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-pomalidomid-info-female-subjects-de | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-pomalidomid-info-male-subjects-de | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G1-smpc-dexamethasone po | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2-smpc-imnovid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2-smpc-imnovid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2-smpc-imnovid | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-el-2024-514988-25 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-en-2024-514988-25 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-2024-514988-25 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-it-2024-514988-25 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-no-2024-514988-25 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pt-2024-514988-25 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Norway | Acceptable 2024-10-11
|
2024-10-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-30 | Norway | Acceptable 2025-05-12
|
2025-05-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-13 | Norway | Acceptable 2025-05-12
|
2025-10-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-30 | Norway | Acceptable 2026-01-19
|
2026-01-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-27 | Acceptable | 2026-05-04 |