Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
Status:
Recruiting
Trial end date:
2026-02-11
Target enrollment:
Participant gender:
Summary
Primary Objectives:
Part 1 (dose finding, experimental substudies):
- 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, 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.
Secondary Objectives:
- To assess the overall response rate (ORR) in each treatment arm.
- 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.
-Substudy 1 (Control Arm):
- To assess clinical outcomes assessments (COAs).
- To assess the incidence of skeletal related events (SREs).
- To assess the time to first occurrence of SRE.
- To assess health care resource utilization related with SREs.
-Substudy 2:
- To assess pain intensity related to skeletal related events (SREs).
- To assess the incidence of SREs.
- To assess the time to first occurrence of SRE.
- To assess health care resource utilization related with SREs.
-Substudy 3:
- To assess patient-reported visual functioning