Trials / Suspended
SuspendedNCT06348147
Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation
- Status
- Suspended
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 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. |
| DRUG | Lenalidomide | Lenalidomide will be administered, once daily orally on Days 1-21 of a 28-day |
| DRUG | 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. |
| DRUG | Dexamethasone | Dexamethasone is a glucocorticoid. |
Timeline
- Start date
- 2026-07-01
- Primary completion
- 2027-05-01
- Completion
- 2029-05-01
- First posted
- 2024-04-04
- Last updated
- 2026-02-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06348147. Inclusion in this directory is not an endorsement.