Sanofi
The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.
Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, Investigator decision, or study termination by the Sponsor i.e., up to Aapproximately 28 months.
Inclusion Criteria: * Participant must be 18 years of age inclusive or older. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is considered one line). * RRMM with measurable disease: * Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or * Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/o…
Pharmaceutical form: Concentrated solution for intravenous infusion; Route of administration: Intravenous infusion
Pharmaceutical form: Tablet; Route of administration: Oral
Pharmaceutical form: Capsule; Route of administration: Oral
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Pharmaceutical form: Solution for injection; Route of administration: Intravenous
Pharmaceutical form: tablet; route of administration: oral
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous