Multiple Myeloma
Conditions
Brief summary
Overall MRD negativity rate, which is defined as the proportion of subjects who have achieved MRD negative status (at 10^-5) by bone marrow aspirate after randomization and prior to progressive disease (PD) or subsequent anti myeloma therapy. Subjects who have achieved MRD negative status on or after PD or after the switch to subsequent anti-myeloma therapy before PD, will not be considered MRD negative in the primary endpoint analysis
Interventions
DRUGDexamethason 4 mg JENAPHARM®
DRUGVELCADE 3.5 mg powder for solution for injection
DRUGDEXAMETHASONE
DRUGRevlimid 25 mg hard capsules
DRUGRevlimid 5 mg hard capsules
DRUGRevlimid 15 mg hard capsules
DRUGRevlimid 10 mg hard capsules
DRUGDARZALEX 1800 mg solution for injection
Sponsors
Janssen - Cilag International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall MRD negativity rate, which is defined as the proportion of subjects who have achieved MRD negative status (at 10^-5) by bone marrow aspirate after randomization and prior to progressive disease (PD) or subsequent anti myeloma therapy. Subjects who have achieved MRD negative status on or after PD or after the switch to subsequent anti-myeloma therapy before PD, will not be considered MRD negative in the primary endpoint analysis | — |
Countries
Czechia, France, Germany, Netherlands, Poland, Spain
Outcome results
None listed