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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.

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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 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 Criteria:

  • None

Study details

Multiple Myeloma

NCT05203003

Assistance Publique - Hôpitaux de Paris

25 January 2024

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