Actively Recruiting
Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Led by Augusta University · Updated on 2026-03-12
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
Augusta University
Lead Sponsor
J
Janssen Scientific Affairs, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed new diagnosis of multiple myeloma following revised IMWG criteria
- Zubrod/ECOG Performance Status of 2 or less
- Renal insufficiency defined as estimated creatinine clearance less than 60 mL/min or requiring dialysis
- No known allergies to any study drugs and adequate organ function
- International normalized ratio (INR) and prothrombin time (PT) less than or equal to 1.5 times the upper limit of normal
- Activated partial thromboplastin time (aPTT) less than or equal to 1.5 times the upper limit of normal
You will not qualify if you...
- Known positive for HIV, Hepatitis B, or Hepatitis C
- Known chronic obstructive pulmonary disease (COPD)
- Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma
- Clinically significant heart disease such as myocardial infarction within 6 months or unstable cardiac conditions
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Grade 3 or 4 peripheral neuropathy
- Other active cancers requiring treatment
- Central nervous system involvement, plasma cell leukemia, or AL amyloidosis
- Active infections requiring systemic therapy
- Known substance abuse disorders interfering with study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Georgia Cancer Center-Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
A
Amany RA Keruakous, MD
CONTACT
J
James T Sonnenberg, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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