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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