Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Drug: Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin
- Registration Number
- NCT04822337
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
This research study is being done to learn if the study drug belantamab mafodotin, in combination with other standard medications, can improve multiple myeloma. This study will also help determine what effects, good and/or bad, this combination of study drugs have on subjects and their cancer, and to evaluate the overall response to this study treatment combination.
- Detailed Description
This is a phase I dose escalation and expansion study in RMM and RRMM followed by a single arm phase II expansion in high risk, NDMM. The phase I portion of the protocol will utilize a standard 3+3 dose escalation design to determine the maximum tolerated dose (MTD) and RP2D of the KRd-belantamab mafodotin combination. The phase II portion of the trial is a two-stage design that will assess the efficacy and safety of the combination in newly diagnosed, high-risk MM patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase I Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin Phase II Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin
- Primary Outcome Measures
Name Time Method Evaluate Complete Response (CR) up to 5 years CR will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of CR or better.
Establish Maximum Tolerated Dose (MTD) time to complete Cycle 1 (28 days) DLTs will be determined for each subject enrolled in Phase I as a binary variable indicating whether the subject experienced a DLT during Cycle 1 of belantamab mafodotin-containing protocol directed induction therapy.
- Secondary Outcome Measures
Name Time Method Complete Response (CR) Up to 5 years CR will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of CR or better
Best Response Up to 5 years The best overall response will be determined as an ordered categorial variable indicating the subject's best response at any point along the treatment continuum.
Time to Best Response (TTBR) up to 30 days post treatment discontinuation Time to best response will be calculated for all subjects achieving an sCR, CR, VGPR or PR. This will be defined as the time from initiation of belantamab mafodotin-containing protocol directed induction therapy to the time of best disease assessment indicating either sCR, CR, VGPR or PR.
Very Good Partial Response (VGPR) up to 5 year will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of VGPR or better.
Overall Response up to 5 years post treatment discontinuation The best overall response will be determined as an ordered categorial variable indicating the subject's best response at any point along the treatment continuum
MRD Negative Up to 5 years . Minimal residual disease (MRD) (via NGF 10-5 and 10-6) will be determined for each subject after suspected CR for Phase I subjects and at the following timepoints for Phase II subjects: after induction therapy, after ASCT, and after 12 cycles of maintenance therapy (post Cycle 18visit) and every 12 months post Cycle 18 sample.
Time to First Response (TTFR) up to 30 days post treatment discontinuation TTFR will be calculated for all subjects achieving an sCR, CR, VGPR, or PR. This will be defined as the time from initiation of belantamab mafodotin-containing protocol directed induction therapy to the time of first disease assessment indicating either sCR, CR, VGPR or PR
Time to Progression (TTP) Up to 5 years TTP is defined as the duration of time from enrollment to the study (treatment start date) to first occurrence of progressive disease
Overall Survival (OS) Up to 8 years OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause.
Duration of Response (DoR) Up to 5 years post treatment response DoR will be calculated for each subject achieving a PR or better and will be calculated from the time of the first assessment that identified response until disease progression or death.
Progression Free Survival (PFS) Up to 8 years PFS is defined as the duration of time from enrollment to the study (treatment start date) to first occurrence of either progressive disease or death (from any cause), whichever comes first.
Trial Locations
- Locations (1)
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States