Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol
-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
-Master Protocol and Substudy 1-ACT16482-01 (Control Arm):
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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