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An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation
This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists. This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Start Date
July 1, 2026
Primary Completion Date
May 1, 2027
Completion Date
May 1, 2029
Last Updated
February 17, 2026
39
ESTIMATED participants
Daratumumab
BIOLOGICAL
Lenalidomide
DRUG
Bortezomib
DRUG
Dexamethasone
DRUG
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
NCT06179888
NCT06152575
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT04973605