multiple myeloma
Conditions
Brief summary
Event free survival (EFS) from the time of randomization, with events being defined as: PD, death, going off protocol treatment due to toxicity, biochemical progression within 4 months after discontinuation of therapy in arm B or less than minimal response after 4 cycles of therapy after the restart of Dara-Rd in arm B, whichever comes first (see protocol section 10.4 for definitions of PD and biochemical progression), Progression free survival (PFS) from the time of randomization, with events being defined as PD (according to definition in section 10.4) or death, whichever comes first
Detailed description
Toxicity, according to CTCAE v5, Adverse event (AE) burden, Quality of Life and PROMs, Cost-effectiveness analysis, Treatment-free interval (TFI) in arm B, Time to response and to maximal response after restart of Dara-Rd in arm B, Time to next treatment (TTNT), PFS2 from the time of randomization to 2nd PD or death, whichever comes first, OS from time of randomization to death from any cause; patients still alive at the date of last contact will be censored, Discontinuation rate and the reasons for discontinuation, Cumulative dose and relative dose intensity (RDI) of daratumumab, lenalidomide and dexamethasone, Dose reductions of daratumumab, lenalidomide and dexamethasone
Interventions
DRUGDARATUMUMAB
DRUGDEXAMETHASONE
DRUGLENALIDOMIDE
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (EFS) from the time of randomization, with events being defined as: PD, death, going off protocol treatment due to toxicity, biochemical progression within 4 months after discontinuation of therapy in arm B or less than minimal response after 4 cycles of therapy after the restart of Dara-Rd in arm B, whichever comes first (see protocol section 10.4 for definitions of PD and biochemical progression), Progression free survival (PFS) from the time of randomization, with events being defined as PD (according to definition in section 10.4) or death, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, according to CTCAE v5, Adverse event (AE) burden, Quality of Life and PROMs, Cost-effectiveness analysis, Treatment-free interval (TFI) in arm B, Time to response and to maximal response after restart of Dara-Rd in arm B, Time to next treatment (TTNT), PFS2 from the time of randomization to 2nd PD or death, whichever comes first, OS from time of randomization to death from any cause; patients still alive at the date of last contact will be censored, Discontinuation rate and the reasons for discontinuation, Cumulative dose and relative dose intensity (RDI) of daratumumab, lenalidomide and dexamethasone, Dose reductions of daratumumab, lenalidomide and dexamethasone | — |
Countries
Netherlands
Outcome results
None listed