Newly-diagnosed multiple myeloma (NDMM)
Conditions
Brief summary
Improvement in the percentage of patients MRD-negative in Arm A vs. Arm B when considering B1 endpoint. B1 endpoint: VRD extended impact only, without considering ERI impact: any patient that require an ERI per protocol before finishing the 18 cycles + ASCT, will be considered MRD-positive at that time, independently of the ERI impact, Non-inferiority in the percentage of patients MRD-negative in Arm A vs. Arm B when considering B2 endpoint. B2 endpoint: VRD extended plus ERI impact: any patient who achieves MRD negativity with ERI before finishing the 18 cycles + ASCT will be considered MRD-negative at that time.
Interventions
DRUGRevlimid 15 mg hard capsules
DRUGRevlimid 5 mg hard capsules
DRUGISATUXIMAB
DRUGIberdomide
DRUGDEXAMETHASONE
DRUGRevlimid 10 mg hard capsules
DRUGVELCADE 3.5 mg powder for solution for injection
DRUGIsatuximab
DRUGRevlimid 25 mg hard capsules
Sponsors
Fundacion PETHEMA
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the percentage of patients MRD-negative in Arm A vs. Arm B when considering B1 endpoint. B1 endpoint: VRD extended impact only, without considering ERI impact: any patient that require an ERI per protocol before finishing the 18 cycles + ASCT, will be considered MRD-positive at that time, independently of the ERI impact, Non-inferiority in the percentage of patients MRD-negative in Arm A vs. Arm B when considering B2 endpoint. B2 endpoint: VRD extended plus ERI impact: any patient who achieves MRD negativity with ERI before finishing the 18 cycles + ASCT will be considered MRD-negative at that time. | — |
Countries
Spain
Outcome results
None listed