Status:
Recruiting
Disease Site:
Multiple Myeloma
Phase:
Official Title:
A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT ID:
NCT#04975997
Link to Full Details:
Description:
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
- Known central nervous system involvement with MM
- Must have documented disease progression during or after their last anti-myeloma regimen
Exclusion Criteria:
- Clinically serious hemorrhage
- History of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy
- Splenectomy within 12 weeks prior to enrollment
- Prior therapy with iberdomide