NCT04643002 : 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

Trial Identifiers

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• NCT04643002
• ACT16482, CT1282

Scientific Title

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

Commercial Sponsor

Sanofi Aventis

Summary

Eligible patients will be randomised to receive isatuximab and dexamethasone, in addition to either SAR439459 (experimental arm) or pomalidomide (control arm). This trial will include a screening period of up to 28 days for participants treated in each arm. Patients will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, Investigator decision, or study termination by the Sponsor, whichever occurs first. Patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until confirmation of disease progression. For patients who discontinue study treatment with confirmed disease progression, follow-up visits will be done every 3 months (12 weeks) from the date of last IMP administration until death or final cutoff date, whichever comes first. Adverse events and survival status will be collected.