RecruitingEarly Phase 1NCT06142396

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

Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

Sponsor

Augusta University

Enrollment

30 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Renal Failure

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four drugs — daratumumab, cyclophosphamide, bortezomib, and dexamethasone — for people who have just been diagnosed with multiple myeloma (a type of blood cancer) and also have kidney problems. **You may be eligible if...** - You have recently been diagnosed with multiple myeloma - You have reduced kidney function (your kidneys are not filtering blood well) or you are on dialysis - You are well enough to perform daily activities with some limitations - Your blood clotting levels are within acceptable range **You may NOT be eligible if...** - You have HIV, Hepatitis B, or Hepatitis C - You have COPD or moderate-to-severe asthma - You have had a heart attack in the last 6 months or have serious heart disease - You are pregnant, breastfeeding, or planning to become pregnant - You have severe nerve damage in your hands or feet - You have another active cancer requiring treatment - You have a current serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

This intervention is Daratumumab-hyaluronidase in combination with the chemotherapy regimen "CyBord" (cyclophosphamide, bortezomib, and dexamethasone) and then with lenalidomide maintenance in patients with newly diagnosed multiple myeloma who have new onset renal failure.