Status:
RECRUITING
Prospective Evaluation of the Prognostic Impact of Measurable Residual Disease (MRD) Within a Phase III Study Comparing a Fixed Duration Therapy Versus Continuous Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Requiring a First Salvage Treatment.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
We propose to conduct an ancillary prospective evaluation of the impact of Dara-Len-Dex discontinuation after 2 years, on the persistence of MRD negativity in patients that were MRD negative at 2 year...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years old) who are included in the CONFIRM phase III trial (ClinicalTrials.gov Identifier: NCT03836014).
- Subject that are still under therapy at 2 years (+/- 3 month) after randomization, either in the fixed duration therapy group or in the continuous therapy group of the CONFIRM protocol
- Subject in complete response at 2 years (+/- 3 month) after randomization.
- Signed informed consent
- Affiliation to a social security system or equivalent
Exclusion
- None
Key Trial Info
Start Date :
April 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT05203003
Start Date
April 22 2022
End Date
December 1 2028
Last Update
December 6 2024
Active Locations (1)
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1
Department of Hematology, Hospital Saint Antoine
Paris, France, 75012