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

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Notable Primary completion date: Nov 1, 2025 to Nov 1, 2027
    • Site contact updated
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2024 to Nov 1, 2024
    • Site details revised
    v4
  3. Notable Start date: Jan 1, 2024 to Oct 1, 2024
    • Site contact updated
    v3
  4. Minor Collaborators expanded, about 4 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06142396
Lead Sponsor Augusta University
Collaborators: Janssen Scientific Affairs, LLC
Conditions
(from sponsor)
Multiple Myeloma, Renal Failure
Related terms Multiple Myeloma, Renal Insufficiency
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov