Daratumumab-based Regimen for Multiple Myeloma with Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What makes the daratumumab-based drug regimen unique for treating multiple myeloma with kidney failure?
This treatment is unique because it combines daratumumab, a monoclonal antibody targeting CD38, with bortezomib, cyclophosphamide, and dexamethasone, specifically for patients with multiple myeloma and kidney failure. It has shown effectiveness in improving kidney function and maintaining a good response in patients who are dependent on dialysis, offering a valuable option for those with severe kidney impairment.12345
What data supports the effectiveness of the drug Daratumumab-based Regimen for Multiple Myeloma with Kidney Failure?
Who Is on the Research Team?
Amany RA Keruakous, MD
Principal Investigator
Augusta University
Are You a Good Fit for This Trial?
This trial is for newly diagnosed multiple myeloma patients with new onset renal failure, without allergies to study drugs, good performance status (able to carry out daily activities), and adequate organ function. It's not for those with substance abuse issues, certain infections (HIV, Hepatitis B/C), severe lung or heart conditions, pregnant/breastfeeding women, CNS involvement diseases like plasma cell leukemia or amyloidosis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive induction treatment with daratumumab-hyaluronidase (dara SC) in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles of 28 days
Restaging
Restaging with repeat PET-CT, bone marrow evaluation, and myeloma serological testing
Further Treatment
Further treatment determined by transplant eligibility: additional 2 cycles of Dara-CyBorD followed by maintenance therapy if transplant ineligible, or autologous stem cell transplantation (ASCT) followed by maintenance therapy if transplant eligible
Maintenance Therapy
Maintenance therapy with lenalidomide and dara SC for 2 years
Follow-up
Participants are monitored every three months for up to 2 years to assess the duration of response or until disease progression or the start of a new line of therapy
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib, Cyclophosphamide, Dexamethasone
- Daratumumab-hyaluronidase
Find a Clinic Near You
Who Is Running the Clinical Trial?
Augusta University
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University