RECRUITING

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

Conditions

Multiple Myeloma Renal Failure Daratumumab Bortezomib Cyclophosphamide Dexamethasone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-01

Study Completion:2027-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06142396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Amany RA Keruakous, MD

CONTACT

706-721-2505

AKERUAKOUS@augusta.edu

James T Sonnenberg, BS

CONTACT

9106192597

jsonnenberg@augusta.edu

Principal Investigator

Amany RA Keruakous, MD

PRINCIPAL_INVESTIGATOR

Augusta University

Study Locations (Sites)

Georgia Cancer Center-Augusta University

Augusta, Georgia, 30912

United States

Collaborators and Investigators

Sponsor: Augusta University

Amany RA Keruakous, MD, PRINCIPAL_INVESTIGATOR, Augusta University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2027-11-01

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

Daratumumab
Bortezomib
Cyclophosphamide
Dexamethasone

Additional Relevant MeSH Terms

Multiple Myeloma
Renal Failure