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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Newly Diagnosed Multiple Myeloma Multiple Myeloma Autologous Stem Cell Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daratumumab, lenalidomide, bortezomib, and dexamethasone

Subjects with newly diagnosed multiple myeloma (NDMM) are eligible for standard-of-care autologous stem cell transplantation (ASCT) and receive daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd).

Group Type EXPERIMENTAL

Daratumumab

Intervention Type BIOLOGICAL

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

Intervention Type DRUG

Lenalidomide will be administered, once daily orally on Days 1-21 of a 28-day

Bortezomib

Intervention Type DRUG

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

Intervention Type DRUG

Dexamethasone is a glucocorticoid.

Interventions

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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.

Intervention Type BIOLOGICAL

Lenalidomide

Lenalidomide will be administered, once daily orally on Days 1-21 of a 28-day

Intervention Type 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.

Intervention Type DRUG

Dexamethasone

Dexamethasone is a glucocorticoid.

Intervention Type DRUG

Eligibility Criteria

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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.