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.

Last updated: December 5, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Leukemia

Cancer/tumors

Treatment

Assessment of MRD

Clinical Study ID

NCT05203003
APHP210482
  • Ages > 18
  • All Genders

Study 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 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 theCONFIRM protocol

  • Subject in complete response at 2 years (+/- 3 month) after randomization.

  • Signed informed consent

  • Affiliation to a social security system or equivalent

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: Assessment of MRD
Phase:
Study Start date:
April 22, 2022
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Department of Hematology, Hospital Saint Antoine

    Paris, 75012
    France

    Active - Recruiting

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