Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients. The primary questions this study aims to answer are: 1. To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord. 2. To evaluate the renal response rate (RRR) a

Trial Details

NCT ID
NCT06142396
Phase
EARLY_PHASE1
Sponsor
Augusta University
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone
Locations (sample)
  • Augusta, Georgia, United States|33.47097,-81.97484

Key Eligibility Criteria

  • Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.
  • Patients must have Zubrod/ECOG Performance Status ≤ 2.
  • Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl \< 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or nece…
  • must not have known allergies to any of the study drugs. Must have adequate organ function.

For full eligibility, visit ClinicalTrials.gov.

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