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

Launched by AUGUSTA UNIVERSITY · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients who have recently been diagnosed with multiple myeloma, a type of blood cancer, and are also experiencing kidney problems. The treatment being tested combines a medication called daratumumab-hyaluronidase (dara SC) with other drugs: cyclophosphamide, bortezomib, and dexamethasone. Researchers want to see how well this combination works over four cycles of treatment, particularly looking at how many patients show significant improvement and how their kidney function responds. Additionally, the trial will explore whether there are differences in treatment responses between African American patients and those from other backgrounds.

To participate in this study, patients need to be between 18 and 75 years old and have a confirmed diagnosis of multiple myeloma with kidney issues. They should also have a good overall health status but cannot have certain serious conditions or infections. Those who take part can expect to receive the treatment for a set period and will be closely monitored for their responses and any side effects. This trial is currently recruiting participants, and it's an important step in finding effective treatments for patients with both multiple myeloma and renal failure.

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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 uncontrolled disease/condition related to or affection cardiac function.
• • 5. Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.
• • 6. Patients with grade 3 or 4 peripheral neuropathy 7. Patients with other active malignancies that require concurrent treatment 8. Known CNS involvement or plasma cell leukemia, or AL amyloidosis 9. Participants with active infection requiring systemic therapy 10. Has known substance abuse disorders that would interfere with cooperation with the requirements of the study.