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OncoMatch/Clinical Trials/NCT06142396

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

Is NCT06142396 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone for multiple myeloma.

Early Phase 1RecruitingAugusta UniversityNCT06142396Data as of May 2026

Treatment: Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone — 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Zubrod/ECOG Performance Status ≤ 2

Prior therapy

No prior treatment (treatment-naive required)

Lab requirements

Blood counts

INR and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.

Kidney function

Renal insufficiency defined as eCrCl < 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or necessitating dialysis

Must have adequate organ function. INR and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Georgia Cancer Center-Augusta University · Augusta, Georgia

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