A multi-center phase III randomized study comparing continuous versus fixed duration therapy with Daratumumab, Lenalidomide, and Dexamethasone for relapsed multiple myeloma (CONFIRM)

Conditions

Onco-hematology

Brief summary

Overall survival (OS) at 4 years after randomization and initiation of salvage therapy.

Detailed description

Response rate according to the IMWG criteria (Durie BG, et al. Leukemia. 2006;20 :1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), during or after the study treatment at the time of data cutoff., Overall response rate, defined as the proportion of subjects who achieve CR or PR according to the IMWG criteria, following salvage therapy., PFS which is defined as the duration from the date of randomization to either progressive disease, according to the IMWG criteria or death, at 4 years after randomization., Incidence of adverse events within the 4 years after randomization, QoL will be evaluated after randomization every 12 weeks until disease progression and then at last follow-up based on the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the EQ-5D 5L (EuroQol - five dimension - five levels)., The Incremental cost-effectiveness ratios (ICERs) expressed in cost per quality adjusted life year (QALY) gained, in cost per Life Year Gained, and in cost per progression free year gained., The budget impact analysis based upon target and prevalent populations’ estimations

Related papers

No related papers found yet.

Interventions

DRUGLENALIDOMIDE

DRUGDEXAMETHASONE

DRUGDARATUMUMAB

DRUGDARZALEX 1800 mg solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) at 4 years after randomization and initiation of salvage therapy.	—

Secondary

Measure	Time frame
Response rate according to the IMWG criteria (Durie BG, et al. Leukemia. 2006;20 :1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), during or after the study treatment at the time of data cutoff., Overall response rate, defined as the proportion of subjects who achieve CR or PR according to the IMWG criteria, following salvage therapy., PFS which is defined as the duration from the date of randomization to either progressive disease, according to the IMWG criteria or death, at 4 years after randomization., Incidence of adverse events within the 4 years after randomization, QoL will be evaluated after randomization every 12 weeks until disease progression and then at last follow-up based on the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the EQ-5D 5L (EuroQol - five dimension - five levels)., The Incremental cost-effectiveness ratios (ICERs) expressed in cost per quality adjusted life year (QALY) gained, in co	—

Measure

Time frame

Response rate according to the IMWG criteria (Durie BG, et al. Leukemia. 2006;20 :1467–1473; Rajkumar SV, et al. Blood. 2011;4691-4695), during or after the study treatment at the time of data cutoff., Overall response rate, defined as the proportion of subjects who achieve CR or PR according to the IMWG criteria, following salvage therapy., PFS which is defined as the duration from the date of randomization to either progressive disease, according to the IMWG criteria or death, at 4 years after randomization., Incidence of adverse events within the 4 years after randomization, QoL will be evaluated after randomization every 12 weeks until disease progression and then at last follow-up based on the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the EQ-5D 5L (EuroQol - five dimension - five levels)., The Incremental cost-effectiveness ratios (ICERs) expressed in cost per quality adjusted life year (QALY) gained, in co

—

Countries

France

Outcome results

None listed