Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
Conditions
Brief summary
MRD negative CR status at 10-5 (as measured in BM by clonoSEQ assay) per IMWG criteria (S. Kumar et al., 2016) as determined by BICR, PFS per IMWG response criteria (S. Kumar et al., 2016) as determined by BICR, defined as the time from the date of randomization to the date of first documented evidence of progressive disease or death, whichever occurs first
Detailed description
• The key secondary endpoint is overall survival (OS) from time of randomization.
Interventions
DRUGRevlimid 15 mg hard capsules
DRUGDARZALEX 1800 mg solution for injection
DRUGtabletten
DRUGRevlimid 10 mg hard capsules
DRUGRevlimid 25 mg hard capsules
DRUGRevlimid 5 mg hard capsules
Sponsors
European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negative CR status at 10-5 (as measured in BM by clonoSEQ assay) per IMWG criteria (S. Kumar et al., 2016) as determined by BICR, PFS per IMWG response criteria (S. Kumar et al., 2016) as determined by BICR, defined as the time from the date of randomization to the date of first documented evidence of progressive disease or death, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| • The key secondary endpoint is overall survival (OS) from time of randomization. | — |
Countries
Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden
Outcome results
None listed