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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 (Jun 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 Jun 2026

Treatment: Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and DexamethasoneThe 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

Treatments studied

Immunotherapy

Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone

Cancer type

Multiple Myeloma

Performance status

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

Zubrod/ECOG Performance Status ≤ 2

Demographics

Ages ≤ 80

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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Frequently asked questions

Is NCT06142396 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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