Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAugusta University
About 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.
Eligibility criteria
Qualifiers
Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.
Patients must have Zubrod/ECOG Performance Status ≤ 2.
Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl < 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or necessitating dialysis
must not have known allergies to any of the study drugs. Must have adequate organ function.
Disqualifiers
1. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
Trial design
Treatments tested in this trial
- Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Georgia Cancer Center-Augusta University30912, AugustaGeorgia, United States
Sponsors and collaborators
Augusta University
Lead sponsor
Janssen Scientific Affairs, LLC
Collaborator
Source ClinicalTrials.gov