Home › Multiple Myeloma › NCT06142396
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
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria. 2. Patients must have Zubrod/ECOG Performance Status ≤ 2. 3. 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 4. must not have known allergies to any of the study drugs. Must have adequate organ function. 5. International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Exclusion Criteria: * 1\. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C. 2\. Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. 4\. 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. 5\. Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study. 6\. 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.
About the study
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.
What is being tested
- Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (combination product)
Sponsor: Augusta University · Participants: 30 · Started: Nov 1, 2024
Contact the study team
- Amany RA Keruakous, MD · Phone: 706-721-2505
- James T Sonnenberg, BS · Phone: 9106192597
Official record on ClinicalTrials.gov — NCT06142396
Locations in the U.S.
| Georgia | Georgia Cancer Center-Augusta University, Augusta |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.