Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Recruiting now · Early Phase 1
Conditions studied: Multiple Myeloma, Renal Failure
In brief
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.
Key facts
- Study ID
- NCT06142396
- Run by
- Augusta University
- People needed
- 30
- Starts
- 2024-11-01
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.
- Patients must have Zubrod/ECOG Performance Status ≤ 2.
- Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl < 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or necessitating dialysis
- must not have known allergies to any of the study drugs. Must have adequate organ function.
- International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
You may not qualify if…
- 1. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
- Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
- Known Clinically significant heart disease is defined as: myocardial infarction within 6 months before enrollment, or unstable or uncontrolled disease/condition related to or affection cardiac function.
- Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.
- Patients with grade 3 or 4 peripheral neuropathy 7. Patients with other active malignancies that require concurrent treatment 8. Known CNS involvement or plasma cell leukemia, or AL amyloidosis 9. Participants with active infection requiring systemic therapy 10. Has known substance abuse disorders that would interfere with cooperation with the requirements of the study.
Where it is running
- Georgia Cancer Center-Augusta University — Augusta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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