Clinical trial NCT06348147: Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
Official title: An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Autologous Stem Cell Transplantation
Keywords: Daratumumab
lenalidomide
bortezomib
dexamethasone
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The rate of achievement of bone marrow minimal residual disease (MRD) negativity
timeFrame: At completion of stem cell transplantation (60 days)
Secondary outcomes:
measure: Progression Free Survival (PFS )
timeFrame: Up to 2 years
measure: Stringent complete response (sCR)
timeFrame: At completion of stem cell transplantation (60 days)
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Therapeutic discontinuation
timeFrame: Up to 2 years
measure: Time to first response
timeFrame: Up to 2 years
measure: Time to best response
timeFrame: Up to 2 years
measure: Maximum depth of response (from PR to CR, including sCR)
timeFrame: Up to 2 years
measure: Overall response rate (ORR)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Samuel M Rubinstein, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: