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

NCT06348147 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: LCCC2323
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Myeloma; Newly Diagnosed Multiple Myeloma; Autologous Stem Cell Transplantation

Keywords

Daratumumab; lenalidomide; bortezomib; dexamethasone

Outcome Measures

Primary Outcomes (1)

• The rate of achievement of bone marrow minimal residual disease (MRD) negativity

  The rate of achievement of bone marrow minimal residual disease (MRD) negativity will be defined as the percentage of subjects achieving MRD negativity as determined by next-generation flow cytometry.

  At completion of stem cell transplantation (60 days)

Secondary Outcomes (8)

• Progression Free Survival (PFS )

  Up to 2 years

• Stringent complete response (sCR)

  At completion of stem cell transplantation (60 days)

• Overall Survival (OS)

  Up to 2 years

• Therapeutic discontinuation

  Up to 2 years

• Time to first response

  Up to 2 years

Study Arms (1)

Daratumumab, lenalidomide, bortezomib, and dexamethasone

EXPERIMENTAL

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).

Biological: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Daratumumab 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.

Daratumumab, lenalidomide, bortezomib, and dexamethasone

Lenalidomide DRUG

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

Daratumumab, lenalidomide, bortezomib, and dexamethasone

Bortezomib 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.

Daratumumab, lenalidomide, bortezomib, and dexamethasone

Dexamethasone DRUG

Dexamethasone is a glucocorticoid.

Daratumumab, lenalidomide, bortezomib, and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥18 years at the time of consent.
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Subjects with Multiple Myeloma.

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; Lenalidomide; Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Samuel M Rubinstein, MD, MSCI

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

US (1)