drugset / Trial / NCT06142396

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

NCT06142396

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-11-01
Primary completion
2027-11-01
Completion
2027-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule
Subject Cyclophosphamide Other / unclassified
Subject Daratumumab Monoclonal antibody Subcutaneous
Subject Dexamethasone Small molecule