Actively Recruiting
Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (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
N/A
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
Researchers are evaluating the effectiveness of an induction treatment combining daratumumab-hyaluronidase with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) in patients newly diagnosed with multiple myeloma who have recently developed kidney failure. The study also aims to explore differences in treatment responses between African American patients and those who are not African American. This is an early phase 1, interventional pilot study addressing a critical need for patients with multiple myeloma and renal impairment, who often have worse outcomes and are underrepresented in clinical trials. Participants receive four cycles of Dara-CyBorD, each cycle lasting 28 days. After these cycles, patients undergo restaging assessments including PET-CT scans, bone marrow evaluation, and blood tests related to myeloma. Based on eligibility for transplant, further treatment will be given: either two more cycles of Dara-CyBorD followed by maintenance therapy for those ineligible for transplant or autologous stem cell transplantation followed by maintenance therapy for those eligible. Maintenance treatment consists of lenalidomide and daratumumab-hyaluronidase given for two years. During the study, participants will be monitored every three months for up to two years or until disease progression or a new treatment begins. Evaluations include measuring the quality of response to therapy, kidney function improvement, duration of response, and independence from dialysis. The primary outcomes focus on very good partial response rate and renal response rate after four months of treatment. Secondary outcomes also assess overall response rate, time to renal response, and transplantation outcomes, ensuring comprehensive monitoring throughout the study period.
CONDITIONS
Brief Title
Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a confirmed new diagnosis of multiple myeloma following revised IMWG criteria.
- Patients must have a Zubrod/ECOG Performance Status of 2 or less.
- Patients must have renal insufficiency defined as estimated creatinine clearance less than 60 mL/min or require dialysis.
- Patients must not have known allergies to any study drugs and must have adequate organ function.
- Patients must have International normalized ratio (INR) and prothrombin time (PT) less than or equal to 1.5 times the upper limit of normal (ULN), and activated partial thromboplastin time (aPTT) less than or equal to 1.5 times ULN.
You will not qualify if you...
- Known positive tests for HIV, Hepatitis B, or Hepatitis C.
- Known chronic obstructive pulmonary disease (COPD).
- Known 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 heart condition.
- Women who are pregnant, breastfeeding, or planning pregnancy during the study.
- Patients with grade 3 or 4 peripheral neuropathy.
- Patients with other active cancers requiring treatment.
- Patients with central nervous system involvement, plasma cell leukemia, or AL amyloidosis.
- Participants with active infections needing systemic therapy.
- Known substance abuse disorders that may interfere with study participation.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 months
Participants receive induction treatment with daratumumab-hyaluronidase combined with cyclophosphamide, bortezomib, and dexamethasone for four 28-day cycles, followed by restaging assessments.
Weekly visits for up to 16 weeks
Duration - Variable, following initial 4 cycles
Further treatment is given based on transplant eligibility: either 2 additional cycles of Dara-CyBorD followed by maintenance therapy, or autologous stem cell transplantation (ASCT) followed by maintenance therapy.
Visits as per physician's discretion during additional cycles and ASCT
Duration - Up to 2 years
Maintenance therapy with lenalidomide and daratumumab-hyaluronidase is administered for 2 years.
Visits every 3 months for maintenance therapy assessments
Duration - Up to 2 years
Participants are followed every three months for up to 2 years or until disease progression or new therapy to assess duration of response.
Quarterly visits every 3 months
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
J
James T Sonnenberg, BS
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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