Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Status:
Recruiting
Trial end date:
2033-10-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- Safety run-in: 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: 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:
Safety run-in
- To assess overall response rate (ORR)
- To assess duration of response (DOR)
- To assess minimal residual disease (MRD) negativity in participants achieving very good
partial response (VGPR) or complete response (CR)
- To assess time to diagnostic (SLiM CRAB) progression or death
- To assess time to first-line treatment for multiple myeloma (MM)
- To assess the potential immunogenicity of isatuximab
- Impact of abnormal cytogenetic subtype
Randomized Phase 3 - Key Secondary Objectives:
To compare between the arms
- MRD negativity
- Sustained MRD negativity
- Second progression-free survival (PFS2)
- Overall survival
Other Secondary Objectives:
To evaluate in both arms
- CR rate
- ORR
- DOR
- Time to diagnostic (SLiM CRAB) progression
- Time to first-line treatment for MM
- Safety and tolerability
- Pharmacokinetics (PK)
- Potential of isatuximab immunogenicity
- Clinical outcome assessments (COAs)