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Recruiting Phase 2 NCT05896228

Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

Trial Parameters

Condition Refractory Multiple Myeloma
Sponsor Benjamin T Diamond, MD
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-02-20
Completion 2029-03-01
Interventions
IberdomideCarfilzomibDaratumumab

Brief Summary

The investigators want to find out whether or not giving patients who have relapsed or refractory multiple myeloma (MM) the experimental medication combination iberdomide, carfilzomib, daratumumab, and dexamethasone (Iber-KDd) may produce better results than the current (standard of care) treatments. This study will examine the tolerability and efficacy of this combination therapy for all participants and the ability of this combination therapy to shrink or prevent MM from returning.

Eligibility Criteria

Inclusion Criteria: 1. Patients with histologically confirmed MM with progressive disease according to the IMWG criteria 47 during or within 60 days of their last regimen who have received 1-3 lines of prior therapy (inclusive of a lenalidomide-containing regimen) and have measurable disease within 4 weeks of enrollment based on one of the following: * Serum monoclonal protein ≥ 1.0 g/dL * Urine monoclonal protein ≥ 200 mg/24 hour * Involved serum immunoglobulin free light chains (FLC) ≥ 10 mg/dL AND abnormal kappa/lambda ratio. Note: Because the primary endpoint is MRD-negativity rate, per the discretion of the Principal Investigator (PI), patients without measurable disease (e.g., M-spike \< 1.0 g/dL) may also be enrolled in line with the IMWG MM response criteria 47. 2. Prior treatment with cluster of differentiation 38 (CD38) -directed therapy is permitted only if all the following are fulfilled: * Best response achieved during CD38-directed therapy was ≥ PR. * Patient did not prog

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