Induction treatment for newly diagnosed multiple myeloma patients with renal failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: AKERUAKOUS@augusta.edu
• Phone: 706-721-2505

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Belantamab Mafodotin or Daratumumab with VRd for Newly Diagnosed High-Risk Myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.