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NCT03836014: Phase 3: IFM 2018-Comparing Continuous Versus Fixed Duration Therapy DRd - RRMM Myeloma

IFM 2018-07

CONFIRM


IFM 2018

NCT03836014: Phase 3: Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma (CONFIRM)


CONFIRM

IFM 2018-07


Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma (CONFIRM)



To conduct a non-inferiority phase III randomized, multicenter, open label trial for treatment of MM at first relapse, comparing the Dara-Len-Dex combination administered continuously until PD, versus a fixed duration of 24 months. The choice of this duration is justified by the currently available evidence with respect to achievement of a plateau in terms of deep disease response, patients' compliance, and physicians' preference according to different surveys. The primary objective of this study is to estimate the OS rate at 4 years after diagnosis of relapse and initiation of salvage therapy. The primary endpoint is OS at 4 years after randomization. The analysis will be performed on both per-protocol and intent-to-treat sets of patients.



Sponsor:

Assistance Publique - Hôpitaux de Paris


Locations

France

 

ClinicalTrials.gov Identifier: NCT03836014


Official Title: A Multi-center Phase III Randomized Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

First Posted: February 11, 2019


Click here to see details on ClinicalTrials.gov


IFM - Intergroupe Francophone du Myélome (myelome.fr)

 

Combination Product: Daratumumab/Lenalidomide/Dexamethasone for 24 months

Combination Product: Daratumumab/Lenalidomide/Dexamethasone until progression

 


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