Clinical Trial

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

Recruiting Early Phase 1
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Summary
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) after 4 cycles of Dara-CyBord.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-11-16; most recent amendment 2026-03-11.
Status change: Not Yet Recruiting → Recruiting 2025-02-20
Trial Details
NCT Number NCT06142396
Lead Sponsor Augusta University
Collaborators: Janssen Scientific Affairs, LLC
Conditions Multiple Myeloma, Renal Failure
Enrollment 30 participants
Start Date 2024-11-01
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-12