Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria. 2. Patients must have Zubrod/ECOG Performance Status ≤ 2. 3. 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 4. must not have known allergies to any of the study drugs. Must have adequate organ function. 5. International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Exclusion Criteria: * 1\. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C. 2\. Known Chronic obstructive pulmonary disease (COPD). 3. Known Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. 4\. Known Clinically significant heart disease is defined as: myocardial infarction within 6 months before enrollment, or unstable or uncontroll