Induction treatment for newly diagnosed multiple myeloma patients with renal failure

Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

This study is testing a new treatment plan for people with newly diagnosed multiple myeloma and kidney problems to see if it helps them respond better to therapy.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Augusta University (other)
• Drugs / interventions: daratumumab, cyclophosphamide, chemotherapy
• Locations: 1 site (Augusta, Georgia)
• Trial ID: NCT06142396 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the efficacy of a treatment regimen combining daratumumab-hyaluronidase, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) in patients with newly diagnosed multiple myeloma who also have renal failure. Participants will receive four cycles of this treatment, followed by assessments of their response rates, particularly focusing on differences between African American and non-African American patients. The study seeks to address the urgent need for effective therapies in this high-risk population, where renal impairment complicates treatment outcomes. The study will also involve restaging through PET-CT and bone marrow evaluations after the treatment cycles.

Who should consider this trial

Good fit: Ideal candidates include individuals with newly diagnosed multiple myeloma and renal insufficiency, specifically those with an eCrCl of less than 60 mL/min.

Not a fit: Patients with known seropositivity for HIV, Hepatitis B, or Hepatitis C, or those with significant heart disease or chronic obstructive pulmonary disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve response rates and renal function in patients with newly diagnosed multiple myeloma and renal failure.

How similar studies have performed: While this approach is novel in its specific focus on renal failure in multiple myeloma, similar studies have shown promise in treating multiple myeloma with combination therapies.

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.

Where this trial is running

Augusta, Georgia

• Georgia Cancer Center-Augusta University — Augusta, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: Amany RA Keruakous, MD — Augusta University
• Study coordinator: Amany RA Keruakous, MD

Conditions: Multiple Myeloma, Renal Failure, Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone