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Trial Title:
Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
NCT ID:
NCT06348147
Condition:
Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Autologous Stem Cell Transplantation
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Bortezomib
Daratumumab
Conditions: Keywords:
Daratumumab
lenalidomide
bortezomib
dexamethasone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Daratumumab
Description:
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.
Arm group label:
Daratumumab, lenalidomide, bortezomib, and dexamethasone
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide will be administered, once daily orally on Days 1-21 of a 28-day
Arm group label:
Daratumumab, lenalidomide, bortezomib, and dexamethasone
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
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.
Arm group label:
Daratumumab, lenalidomide, bortezomib, and dexamethasone
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone is a glucocorticoid.
Arm group label:
Daratumumab, lenalidomide, bortezomib, and dexamethasone
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27516
Country:
United States
Contact:
Last name:
Ralph L Dessieu
Email:
ralph-lyne_dessieu@med.unc.edu
Investigator:
Last name:
Samuel M Rubinstein, MD, MSCI
Email:
Principal Investigator
Start date:
December 2024
Completion date:
August 2028
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06348147
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
