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A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination with Bortezomib (Velcade®), Lenalidomide and Dexamethasone versus Bortezomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514417-34-00
Acronym
EFC12522
Enrollment
308
Registered
2024-09-19
Start date
2017-12-14
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

Progression free survival (PFS)

Detailed description

Complete response (CR), Minimal residual disease (MRD) negativity rate for participants with CR, Very good partial response (VGPR) or better rate, Overall survival (OS), Overall response rate (ORR), Time to progression (TTP), Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), PFS on next line of therapy (PFS2), PFS in MRD negative participants, Sustained MRD negativity ≥12 months rate, Adverse Events, Assessment of PK parameter: Ctrough, Immunogenicity, Participants reported outcome (PRO): QLQ-C30, PRO: QLQ-MY20, PRO: EQ-5D-5L

Interventions

DRUGDexamethason 4 mg JENAPHARM®
DRUGRevlimid 25 mg hard capsules
DRUGRevlimid 5 mg hard capsules
DRUGRevlimid 20 mg hard capsules
DRUGZelvina 25 mg hard capsules
DRUGRevlimid 10 mg hard capsules
DRUGRevlimid 15 mg hard capsules
DRUGVELCADE 3.5 mg powder for solution for injection
DRUGZelvina 5 mg hard capsules
DRUGDexamethasone 3.3 mg/ml solution for injection
DRUGDexaGalen® 8 mg injekt Injektionslösung
DRUGIsatuximab
DRUGZelvina 10 mg hard capsules
DRUGZelvina 20 mg hard capsules
DRUGZelvina 15 mg hard capsules

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression free survival (PFS)—

Secondary

MeasureTime frame
Complete response (CR), Minimal residual disease (MRD) negativity rate for participants with CR, Very good partial response (VGPR) or better rate, Overall survival (OS), Overall response rate (ORR), Time to progression (TTP), Duration of response (DOR), Time to first response (TT1R), Time to best response (TTBR), PFS on next line of therapy (PFS2), PFS in MRD negative participants, Sustained MRD negativity ≥12 months rate, Adverse Events, Assessment of PK parameter: Ctrough, Immunogenicity, Participants reported outcome (PRO): QLQ-C30, PRO: QLQ-MY20, PRO: EQ-5D-5L—

Countries

Czechia, Denmark, France, Germany, Greece, Italy, Lithuania, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026