IMPEDE

Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

What will happen during the trial?

The study is divided into two parts:

Part 1 (Run-in safety phase): In this safety-run in phase a total of six subjects will be enrolled at the coordinating site (Medical College of Wisconsin) to assess potential dose-limiting toxicities that may be associated with the addition of isatuximab with pomalidomide, elotuzumab and dexamethasone.

Part 2 (Expansion phase): In this part, up to 47 additional subjects will be enrolled.

The study hypothesis is that the isatuximab in combination with elotuzumab, pomalidomide, and dexamethasone (Isa-EPD) will be safe and lead to superior response rates than seen with either isatuximab with pomalidomide and dexamethasone or elotuzumab with pomalidomide and dexamethasone in subjects with relapsed and/or refractory multiple myeloma.

More Information

Trial Status
Accepting patients
Trial Phase
Phase 2
Enrollment
53 patients (estimated)
Sponsors
Medical College of Wisconsin
Tags
Monoclonal Antibody, CD38
Trial Type
Treatment
Last Update
3 months ago
SparkCures ID
1158
NCT Identifier
NCT04835129

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