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Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
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.
Official title: An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2026-07
Completion Date
2029-05
Last Updated
2026-06-09
Healthy Volunteers
No
Interventions
Daratumumab
Daratumumab is a CD38-directed cytolytic antibody indicated for the treatment of adults with multiple myeloma. 1800 mg will be given subcutaneously according to its standard package insert schedule.
Lenalidomide
Lenalidomide will be administered, once daily orally on Days 1-21 of a 28-day
Bortezomib
Bortezomib is a proteasome inhibitor indicated for the treatment of adult patients with multiple myeloma, will be given subcutaneously once weekly on days 1, 8, and 15 of every 28 day cycle.
Dexamethasone
Dexamethasone is a glucocorticoid.
Locations (1)
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States