Dara-CyBorD for Newly Diagnosed Multiple Myeloma with Renal Failure

This study is testing a treatment called Daratumumab-hyaluronidase in combination with Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) for people newly diagnosed with multiple myeloma who also have kidney problems (renal failure). The goal is to see how well this treatment works to improve their kidney function and reduce their cancer after four cycles. You may be able to join if you are between 18 and 80 years old, have newly diagnosed multiple myeloma, and have kidney insufficiency (eCrCl < 60 mL/min or requiring dialysis). The study is also specifically looking at how African American patients respond compared to non-African American patients. The study aims to enroll 30 participants.

Study design
This is a prospective, interventional pilot study. All participants will receive the same treatment regimen.
What's involved
You will receive induction treatment with Dara-CyBorD for four cycles of 28 days each. After this, you will have restaging tests including PET-CT, bone marrow evaluation, and blood tests.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 4 months after starting treatment.

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NCT06142396

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

Recruiting
EARLY_PHASE1Ages 18–80InterventionalTreatment
Augusta University
~30 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
VGPR
Measured over 4 months
+1 more outcome measured
Multiple Myeloma
Renal Failure
1 sites across 1 states
Georgia1
  • Amany RA Keruakous, MD · PRINCIPAL_INVESTIGATOR · Augusta University

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

1\. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
  • VGPR4 months

    Very good partial response rate (VGPR) or better after 4 cycles of Dara-CyBorD

  • Renal Response Rate (RRR)4 months

    Renal response rate (RRR, defined as \> 30% improvement in creatinine clearance - CrCl from baseline at the point of study entry) after 4 cycles of Dara-CyBorD