Phase II Study of Daratumumab Pre-Mobilization and Post-ASCT in Multiple Myeloma
- Registration Number
- NCT04230031
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
This study will use the drug daratumumab in patients who did not achieve at least a very good partial response (VGPR) and are already planned to have an Autologous Stem Cell Transplant (ASCT). Daratumumab will be given before the stem cell collection to attempt to get rid of any multiple myeloma cells that may be present in the stem cell collection and after the ASCT to get rid of any multiple myeloma cells that may be remaining.
- Detailed Description
This is a single arm, two-stage, phase II study to evaluate the rate of ≥ Complete Response (CR) post-Autologous Stem Cell Transplant (ASCT) in Multiple Myeloma (MM) subjects who failed to achieve at least a Very Good Partial Response (VGPR) post initial induction therapy for newly diagnosed disease, and for whom an ASCT is planned. Subjects will be treated with four weekly doses of daratumumab before mobilization for Hematopoietic Progenitor Cells (HPC) collection, followed by high dose chemotherapy and ASCT and four weekly doses of daratumumab after ASCT. A two-stage design will be implemented. Twenty three (23) subjects will be enrolled in the first stage, and if at least 12 of the 23 subjects have at least a CR after ASCT, an additional 16 subjects will be enrolled in the second stage (a total of 39 subjects).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1: Daratumumab Daratumumab Pre-ASCT and Post-ASCT: Daratumumab
- Primary Outcome Measures
Name Time Method Complete Response (CR) Rate Post-ASCT up to 100 days post-ASCT CR or better will be determined for each subject as binary variables indicating whether or not best overall response post-ASCT is a CR or better as determined by the IMWG 2016 response criteria.
- Secondary Outcome Measures
Name Time Method VGPR+ Rate up to 100 days post-ASCT Post ASCT VGPR+ response will be determined for each subject as a binary variable indicating whether or not the subject achieved a post-ASCT response of VGPR or better as determined by the IMWG response criteria
Time to First Response (TTFR) up to 100 days post-ASCT TTFR is defined as the time from start of induction therapy to the time when the first occurrence of a post-ASCT VGPR or better was achieved.
Time to Best Response (TTBR) up to 100 days post-ASCT TTBR is defined as the time from start of induction therapy to the time when the best response of VGPR or better was achieved.
Duration of Response (DOR) up to 7 years DoR will be calculated separately for each subject achieving PR or better, VGPR or better, and CR or better. The DoR intervals will be calculated from the time of the first assessment that identified response until disease progression or death from any cause.
Progression-Free Survival (PFS) up to 7 years PFS is defined as the duration of time from start of induction therapy to first occurrence of either progressive disease or death from any cause
Time to Progression (TTP) up to 7 years TTP will be calculated in the same fashion as described for PFS with the exception that for subjects who die for causes other than disease progression.
Time to Next Treatment (TTNT) up to 7 years TTNT will be calculated from start of induction therapy until the start of the first subsequent anti-cancer therapy after all protocol directed therapy is completed.
Overall Survival (OS) up to 7 years OS is defined as the duration from start of induction therapy to the date of death from any cause.
Trial Locations
- Locations (1)
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States