Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
530
Countries
11
Sites
41
Plasma cell myeloma
- Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the …
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
- 25 Jun 2020 → ongoing
- Decision date (initial)
- 2024-02-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507419-37-00
- EudraCT number
- 2019-003139-47
- WHO UTN
- U1111-1222-7068
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Efficacy, Safety, Therapy, Pharmacokinetic
- Safety run-in Part: To confirm the recommended dose of isatuximab when combined with
lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
- Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression free survival when
compared to lenalidomide and dexamethasone in participants with high-risk SMM
Secondary objectives 22
- Safety run-in Part: To assess overall response rate (ORR
- Safety run-in Part: To assess duration of response (DOR)
- Safety run-in Part: To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR)
- Safety run-in Part: To assess time to diagnostic (SLiM CRAB) progression or death
- Safety run-in Part: To assess time to first-line treatment for multiple myeloma (MM)
- Safety run-in Part: To assess the potential immunogenicity of isatuximab
- Safety run-in Part : Impact of abnormal chromosomal subtype on participant outcome
- Randomized Phase 3 Part: To compare between the arms: MRD negativity
- Randomized Phase 3 Part: To compare between the arms: Sustained MRD negativity
- Randomized Phase 3 Part: To compare between the arms: Second progression-free survival (PFS2)
- Randomized Phase 3 Part: To compare between the arms: Overall survival
- Randomized Phase 3 Part: To evaluate in both arms: CR rate
- Randomized Phase 3 Part: To evaluate in both arms: ORR
- Randomized Phase 3 Part: To evaluate in both arms: DOR
- Randomized Phase 3 Part: To evaluate in both arms: Time to diagnostic (SLiM CRAB) progression
- Randomized Phase 3 Part: To evaluate in both arms: Time to biochemical progression
- Randomized Phase 3 Part: To evaluate in both arms: Time to first-line treatment for MM
- Randomized Phase 3 Part: To evaluate in both arms: Impact of abnormal chromosomal subtype on participant outcome
- Randomized Phase 3 Part: To evaluate in both arms: Safety and tolerability
- Randomized Phase 3 Part: To evaluate in both arms: Pharmacokinetics (PK)
- Randomized Phase 3 Part: To evaluate in both arms: Potential of isatuximab immunogenicity
- Clinical outcome assessments (COAs)
Conditions and MedDRA coding
Plasma cell myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10035226 | Plasma cell myeloma | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- 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
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Participant must be at least 18 years of age inclusive or older
- Participants who are diagnosed within 5 years with SMM (per International Myeloma Working Group [IMWG] criteria), defined as serum M-protein ≥30 g/L or urinary M- protein ≥500 mg per 24 hour or both, and/or clonal bone marrow plasma cells (BMPCs) 10% to <60%, and absence of myeloma defining events or other related conditions and with high-risk SMM
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2
- Capable of giving voluntary written informed consent
- Absolute neutrophil count (ANC) ≥1000/µL (1 × 109/L)
- Platelets ≥50,000/µL (50 × 109/L)
- Total bilirubin ≤3 mg/dL (except Gilbert syndrome, in which direct bilirubin should be - ≤5 mg/dL).
- Alanine aminotransferase ≤3× upper limit of normal (ULN), aspartate aminotransferase ≤ 3 × ULN.
Exclusion criteria 24
- -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL
- - Prior exposure to approved or investigational treatments for SMM or multiple myeloma (MM) (including but not limited to conventional chemotherapies, immunomodulatory imid drugs, or Proteasome inhibitors); concurrent use of bisphosphonates or receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor denosumab is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
- - Ongoing treatment with corticosteroids with a dose >10 mg prednisone or equivalent per day at the time of randomization (or first study intervention administration in safety run-in cohort)
- -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m²(Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL
- - Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control
- Vaccination with a live vaccine 4 weeks before the start of the study drug. Seasonal flu vaccines that do not contain live virus are permitted
- -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both). Transfusionsupport or concurrent treatment with erythropoietin stimulating agents is not permitted
- -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): ≥ 1 bone lytic lesion of ≥5mm in size
- -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): BMPCs ≥60%
- -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L
- -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter by MRI)
- - Clinically significant cardiac or vascular disease within 3 months prior to randomization, e.g. Myocardial Infarction; Unstable Angina; Coronary (e.g. Coronary Artery Bypass Graft, Percutaneous Coronary Intervention) or peripheral artery revascularization, Left Ventricular Ejection Fraction <40%, Heart Failure NYHA III-IV, Stroke, Transient Ischemic Attack, Pulmonary Embolism, other thromboembolic event, cardiac arrhythmia (Grade 3 or higher by NCI-CTCAE Version 5.0)
- Primary systemic and localized amyloid light chain (AL) amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), standard risk smoldering myeloma, soft-tissue plasmacytoma, and symptomatic myeloma
- - Uncontrolled infection within 28 days prior to randomization in Phase 3 or first study intervention administration in safety run-in
- Patient can be eligible if anti-HBc Immunoglubolin G (IgG) positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative. If anti-HBV therapy in relation with prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period
- Patients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met
- - Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A (defined as positive hepatitis A antigen or positive IgM). HIV serology at screening will be tested for German participants and any other country where required as per local regulations and serology hepatitis B and C at screening will be tested for all participants.
- Uncontrolled or active hepatitis B virus (HBV) infection: Patients with positive Hepatitis B surface antigen (HBsAg) and/or HBV Deoxyribonucleic acid(DNA)
- Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion
- -Patients with positive anti-HCV and undetectable HCV ribonucleic acid (RNA) without antiviral therapy for HCV are eligible
- - Malabsorption syndrome or any condition that can significantly impact the absorption of lenalidomide
- - Any of the following within 3 months prior to randomization (or first study intervention administration in safety run-in cohort): treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis
- - Received treatment (eg surgery, radiotherapy, medication) for a malignancy within 3 years of randomization (or first study intervention administration in safety run-in cohort)
- Active hepatitis C virus (HCV) infection: positive HCV RNA and negative anti-HCV
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Number of participants with treatment-emergent: adverse events (AEs) and serious adverse events - Safety Run-in Part
- Plasma concentration of isatuximab during the treatment period: - Safety Run-in Part
- Receptor density/receptor occupancy - Safety Run-in Part
- Progression-free survival (PFS) - Randomized Phase 3 Part
Secondary endpoints 29
- Overall response rate (ORR) - Safety Run-in Part
- Duration of response (DOR) - Safety Run-in Part
- Minimal residual disease (MRD) negativity -Safety Run-in Part
- Time to diagnostic (SLiM CRAB) progression or death - Safety Run-in Part
- Time to first-line treatment for multiple myeloma (MM) - Safety Run-in Part
- Number of participants with anti-drug antibodies (ADA) against isatuximab - Safety Run-in Part
- PFS in participants with chromosomal abnormalities - Safety Run-In Part
- Overall Survival (OS) in participants with chromosomal abnormalities - Safety Run-In Part
- Minimal residual disease (MRD) negativity – Randomized Phase 3 Part
- Sustained MRD negativity - Randomized Phase 3 Part
- Second PFS (PFS2) - Randomized Phase 3 Part
- OS - Randomized Phase 3 Part
- Complete response (CR) rate - Randomized Phase 3 Part
- Overall Response Rate (ORR) – Randomized Phase 3 Part
- Duration of response (DOR) – Randomized Phase 3 Part
- Time to diagnostic (SLiM CRAB) progression - Randomized Phase 3 Part
- Time to biochemical progression - Randomized Phase 3 Part
- Time to first-line treatment for MM- Randomized Phase 3 Part
- PFS in participants with chromosomal abnormalities - Randomized Phase 3 Part
- OS in participants with chromosomal abnormalities - Randomized Phase 3 Part
- Number of participants with Treatment- emergent adverse events (AEs) and serious adverse events - Randomized Phase 3 Part
- Plasma concentration of isatuximab (Ctrough)- Safety Run-in and Randomized Phase 3 Part
- Concentration observed at the end of intravenous infusion.(Ceoi)- Safety Run-in Part
- Number of participants with Incidence of anti- drug antibodies (ADA) against isatuximab-
- European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 - Randomized Phase 3
- EORTC QLQ-MY20 - Randomized Phase 3 Part
- EQ-5D-5L - Randomized Phase 3 Part
- Randomized Phase 3: HRUPQ - Randomized Phase 3 Part
- Patient's Qualitative Assessment of Treatment Version 2 (PQAT-v2) - Randomized Phase 3 Part
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 21
PRD8721744 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00507
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721743 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00506
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721745 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00502
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721704 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00504
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD8721724 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- MA1339/00505
- MA holder
- ADALVO LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
DexaGalen® 8 mg injekt Injektionslösung
PRD801335 · Product
- Active substance
- Dexamethasone Sodium Phosphate Ph. Eur.
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 49345.01.00
- MA holder
- GALENPHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264287 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264311 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/014
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264267 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/009
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264271 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264288 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/011
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264307 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/013
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264292 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/010
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 7875 mg milligram(s)
- Max treatment duration
- 24 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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD988427 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 2640 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- 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
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 2640 mg milligram(s)
- Max treatment duration
- 24 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
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
PRD10653334 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 500 mg/kg milligram(s)/kilogram
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
PRD10652636 · Product
- Active substance
- Isatuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 500 mg/kg milligram(s)/kilogram
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- SANOFI AVENTIS RECHERCHE ET DEVELOPPEMENT (SAR)
- Paediatric formulation
- No
- Orphan designation
- No
Dexamethasone 3.3 mg/ml solution for injection
PRD302046 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Substance synonyms
- SODIUM DEXAMETHASONE PHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 01502 /0079
- MA holder
- HAMELN PHARMA LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for clinical supplies
Auxiliary 4
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP1159503 · ATC
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R06AA02 — DIPHENHYDRAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lidocaine Hydrochloride Monohydrate
SCP1095637 · ATC
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1139557 · ATC
- Active substance
- Montelukast Sodium
- Route of administration
- ORAL
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R03DC03 — MONTELUKAST
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sanofi-Aventis Recherche & Developpement
- Sponsor organisation
- Sanofi-Aventis Recherche & Developpement
- Address
- 1 Avenue Pierre Brossolette
- City
- Chilly Mazarin
- Postcode
- 91380
- 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 21
| Organisation | City, country | Duties |
|---|---|---|
| Centrala Farmaceutyczna Cefarm S.A. ORG-100019105
|
Radomsko, Poland | Code 14 |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
| SYNLAB Hungary Kft. ORG-100047251
|
Budapest XXI, Hungary | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| PHOENIX lekarensky velkoobchod s.r.o. ORG-100019669
|
Prague, Czechia | Code 14 |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| PetMobile Kft. ORG-100047817
|
Budakalasz, Hungary | Code 14 |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Laboratory analysis |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz ORG-100041290
|
Kaposvar, Hungary | Other |
| Depo-pack S.r.l. ORG-100013780
|
Saronno, Italy | Code 14 |
| Affidea Magyarorszag Kft. ORG-100047239
|
Budapest VIII, Hungary | Other |
| Medicopus Nonprofit Kft. ORG-100032355
|
Kaposvar, Hungary | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Labcorp Early Development Laboratories Limited ORG-100011365
|
Harrogate, United Kingdom | Other |
| Orszagos Verellato Szolgalat ORG-100022488
|
Budapest XI, Hungary | Other |
| Semmelweis Egyetem ORG-100049145
|
Budapest, Hungary | Other |
| Cellcarta Biosciences Inc. ORG-100042227
|
Montreal, Canada | Other |
| ESMS Global Limited ORG-100023149
|
London, United Kingdom | Other |
| CellCarta Biosciences ORG-100039314
|
Charleroi, Belgium | Other |
| Scanomed Kft. ORG-100047793
|
Debrecen, Hungary | Other |
Locations
11 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 20 | 5 |
| Denmark | Ongoing, recruitment ended | 11 | 3 |
| France | Ongoing, recruitment ended | 40 | 9 |
| Germany | Ongoing, recruitment ended | 7 | 2 |
| Greece | Ongoing, recruitment ended | 36 | 3 |
| Hungary | Ongoing, recruitment ended | 12 | 3 |
| Italy | Ongoing, recruitment ended | 41 | 4 |
| Lithuania | Ongoing, recruitment ended | 10 | 1 |
| Norway | Ongoing, recruitment ended | 28 | 2 |
| Poland | Ongoing, recruitment ended | 18 | 2 |
| Spain | Ongoing, recruitment ended | 49 | 7 |
| Rest of world
Canada, Brazil, China, United States, Korea, Democratic People's Republic of, Turkey, New Zealand, United Kingdom, Japan, Australia, Israel
|
— | 258 | — |
Investigational sites
University Hospital Olomouc
Hemato-onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
Interni hematoonkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, 708 00, Poruba
Vseobecna Fakultni Nemocnice V Praze
I. interni klinika, U Nemocnice 499/2, Nove Mesto, Prague 2
Region Sjaelland
Hematologisk afd, Sygehusvej 10, 4000, Roskilde
Rigshospitalet
Clinical Trial Unit 2081, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
Department of Haematology, Sdr, Søndre Skovvej 15, Aalborg
Centre Hospitalier Universitaire De Lille
Département Hématologie, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centre Hospitalier Universitaire De Poitiers
Service hematologie et Therapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Rennes
Service Hematologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Departemental Vendee
Onco-hématologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Assistance Publique Hopitaux De Paris
Hematologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Hopital Saint Antoine
Service hematologie et Therapie Cellulaire, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospital Region Metz Thionville
Service hematologie, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03
Centre Hospitalier De La Cote Basque
Service d'hematologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Universitaire Grenoble Alpes
Hématologie Clinique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Universitaetsklinikum Heidelberg AöR
Universitatsklinikum Heidelberg( #1), Im Neuenheimer Feld 410, Neuenheim, Heidelberg
University Medical Center Hamburg-Eppendorf
Universitatsklinikum Hamburg-Eppendorf (#1), Martinistrasse 52, Eppendorf, Hamburg
Theageneio Cancer Hospital
Hematology Department, Simeonidi Alex 2, 546 39, Thessaloniki
Alexandra Hospital
Oncology-Hematology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
Evangelismos S.A.
Hematology Clinic, Ipsiladou 45-47, 106 76, Athens
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Hematologiai es Ossejt-transzplantacios Osztaly, Albert Florian Ut 5-7, 1097, Budapest IX
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Hematologia Osztaly, Tallian Gyula Utca 20-32, 7400, Kaposvar
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Humanitas Research Hospital
Oncologia ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera S Maria Di Terni
S. C. Oncoematologia, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Ospedaliero Universitaria Delle Marche
SOD Clinica Ematologica, Via Conca 71, 60126, Ancona
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Hematology, Oncology and Transfusion Medicine Center, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Oslo University Hospital HF
Poliklinikk, Blodsykdommer bygn 20, Taarnbygget, Kirkeveien 166, Oslo
Helse Bergen HF
Haukeland Universitetssykehus HF( #1), Jonas Lies Vei 65, 5021, Bergen
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddzial Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitario De Salamanca
Servicio de Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital De La Santa Creu I Sant Pau
Servicio de Hematologia, Carrer De San Quinti 89, 08041, Barcelona
Hospital Clinico Universitario Lozano Blesa
Servicio de Hematologia, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Clinic De Barcelona
Servicio de Hematologia, Calle Villarroel 170, 08036, Barcelona
Clinica Universidad De Navarra
Servicio de Hematologia, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario 12 De Octubre
Servicio de Hematologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Dr Peset Aleixandre
Servicio de Hematologia, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2021-06-03 | 2021-06-03 | 2023-10-23 | ||
| Denmark | 2020-06-25 | 2020-06-25 | 2023-10-23 | ||
| France | 2021-03-19 | 2021-03-19 | 2023-10-23 | ||
| Germany | 2022-02-09 | 2022-02-09 | 2023-10-23 | ||
| Greece | 2021-04-08 | 2021-04-08 | 2023-10-23 | ||
| Hungary | 2020-09-18 | 2020-09-18 | 2022-10-25 | ||
| Italy | 2021-04-28 | 2021-04-28 | 2023-03-06 | ||
| Lithuania | 2020-07-10 | 2020-07-10 | 2023-10-23 | ||
| Norway | 2020-08-31 | 2020-08-31 | 2023-10-23 | ||
| Poland | 2021-09-13 | 2021-09-13 | 2023-10-23 | ||
| Spain | 2020-09-11 | 2020-09-11 | 2023-10-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 126 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1-rdct-protocol-el-2023-507419-37-00 | 6 |
| Protocol (for publication) | d1-rdct-protocol-en-2023-507419-37-00 | 6 |
| Protocol (for publication) | d4-patient-facing-material-COA-live-patient-guide-es-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-cs-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-de-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-el-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-en-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-fr-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-hu-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-it-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-lt-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-no-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-eCOA-live-patient-guide-pl-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-cs-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-de-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-el-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-en-2019-003139-47 | 2 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-es-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-fr-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-hu-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-it-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-lt-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-C30-pl-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-cs-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-de-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-el-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-en-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-es-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-fr-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-hu-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-it-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-lt-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EORTC QLQ-MY20-pl-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-cs-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-da-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-de-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-el-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-en-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-es-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-fr-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-hu-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-it-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-lt-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-no-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-EQ-5D-5L-pl-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-other-information-given-to-participant-da-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-cs-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-da-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-de-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-el-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-en-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-es-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-fr-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-hu-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-it-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-lt-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-no-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-PQATv2-pl-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-QLQ-C30-da-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-QLQ-C30-no-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-QLQ-MY20-da-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-QLQ-MY20-no-2019-003139-47 | 1 |
| Protocol (for publication) | d4-patient-facing-material-questionnair list for publication-en-2019-003139-47 | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangemens-en-waiver | 1 |
| Recruitment arrangements (for publication) | K1-recruitment-arrangements-en | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum-cz | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-addendum1-fr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-biobank-de | 4.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-dtp-gr | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future use research-it | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-future use-gr | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-gdpr-cz | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-genetic-hu | 1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-hu | 7.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-da | 12 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-es | 7.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-fr | 6 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-gr | 7.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-lt | 10 |
| Subject information and informed consent form (for publication) | L1-sis-icf-main-no | 9 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-cz | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-da | 5 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-de | 5.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-es | 5.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-hu | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-it | 4.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-lt | 2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-no | 6 |
| Subject information and informed consent form (for publication) | L1-sis-icf-partner-pregnancy-pl | 4.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-de | 8.0 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-it | 7.1 |
| Subject information and informed consent form (for publication) | L1-sis-icf-patient-pl | 7 |
| Subject information and informed consent form (for publication) | L1-sis-icf-pregnancy-fr | 3 |
| Subject information and informed consent form (for publication) | L1-sis-icf-privacy-it | 5.2 |
| Subject information and informed consent form (for publication) | L1-sis-icf-run-in-no | 2 |
| Subject information and informed consent form (for publication) | L1-sis-pregnant-partner-gr | 4.1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-leaflet-da | 2 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-patient-card-hu | 4.1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-ppp-part3-de | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-release-from-confidentiality-de | 1 |
| Subject information and informed consent form (for publication) | L2-other-subject-information-material-release-from-confidentiality-pregnant-partner-de | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-UK SmPC - Dexamethasone 3 3mg ml | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-UK SmPC - Dexamethasone 3 3mg ml | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-UK SmPC - Revlimid 25mg | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-UK SmPC - Revlimid 25mg | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | g2-smpc-combination-UK SmPC-Dexamethasone 4mg | 2 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-cs-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-el-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-en-2023-507419-37-00 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-es-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-fr-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-hu-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-it-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-lt-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-no-2019-003139-47 | 1 |
| Synopsis of the protocol (for publication) | d1-lay-protocol-synopsis-pl-2019-003139-47 | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-17 | France | Acceptable 2024-02-14
|
2024-02-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-08 | Acceptable | 2024-04-25 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-09 | Acceptable | 2024-07-09 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-25 | France | No conclusion 2024-11-25
|
2024-11-28 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-26 | France | No conclusion 2024-11-25
|
2025-05-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-24 | France | Acceptable 2025-09-29
|
2025-09-30 |