Brief Summary
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.
Intervention / Treatment
- Drug: Isatuximab
- Drug: Dexamethasone
- Drug: Pomalidomide
- Drug: Belantamab mafodotin
- Drug: Pegenzileukin
- Drug: SAR439459
- Drug: Belumosudil
- Drug: Evorpacept
Inclusion Criteria
- Participant must be 18 years of age inclusive or older.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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 transplanta procedure that involves replacing unhealthy blood-forming cells (stem cells) with healthy stem cells 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/or
- Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria (serum Ig free light chain ≥10 mg/dL and abnormal serum Ig kappa lambda free light chain ratio <0.26 or >1.65).
- Men or woman or childbearing potential should agree to use contraception.
- Substudy 01, 06: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 12 months after the last dosethe amount of medication taken. “Exposure” is defined as at least 2 cycles of therapy.
- Substudies 02, 03: Anti-CD38 therapy naïve or prior exposure to such drugs without being refractory but with a wash out of at least 6 months after the last dose. “Refractory” is defined as progressing within 60 days of last dose of anti-CD38 targeting therapy.
- Substudy 04: Anti-CD38 and anti-B cell maturation antigen (BCMA) therapy (if available) prior exposed participants with RRMM. For anti-CD38, “Exposure” is defined as at least 2 cycles of therapy. For anti-BCMA therapy if available, exposure is defined by at least 2 cycles of therapy.
- Substudy 05: Participants with RRMM with at least 2 cycles of prior exposure to anti-CD38 therapy. For participants to whom BCMA targeted therapymedication that targets specific molecular features of cancer cells is available (ie, approved in their region and can be reimbursed), at least 2 cycles of prior exposure to a BCMA targeted agent is mandatory.