Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06348147

Patient View

This Phase II trial evaluates an attenuated Dara-RVd regimen with once-weekly bortezomib for NDMM patients eligible for ASCT. Participants must be ≥18, have ECOG ≤ 2, and provide informed consent. Interventions include daratumumab (1800 mg subcutaneously), lenalidomide (orally on Days 1-21), bortezomib (subcutaneously on Days 1, 8, 15), and dexamethasone.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

  1. Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
  2. Age ≥18 years at the time of consent.
  3. Eastern Cooperative Oncology Group (ECOG) ≤ 2
  4. Subjects with Multiple Myeloma.

Exclusion Criteria

  1. Active infection requiring systemic therapy or other serious infection within 14 days prior to study treatment.
  2. Pregnant or breastfeeding.

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