Status:
RECRUITING
Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure
Lead Sponsor:
Augusta University
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Multiple Myeloma
Renal Failure
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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 p...
Detailed Description
Acute renal impairment (RI) is a myeloma emergency. Diagnosis should be established as fast as possible, and antimyeloma therapy should be started immediately after confirmation of the diagnosis to re...
Eligibility Criteria
Inclusion
- 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.
- International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06142396
Start Date
November 1 2024
End Date
November 1 2027
Last Update
February 21 2025
Active Locations (1)
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1
Georgia Cancer Center-Augusta University
Augusta, Georgia, United States, 30912