Pilot Study of Daratumumab with Cyclophosphamide, Bortezomib, and Dexamethasone to Treat Newly Diagnosed Multiple Myeloma Patients with Kidney Failure

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.

Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure