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. (MRD-CONFIRM)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Other: Assessment of MRD

Study type: Observational

Funder types: Other

Identifiers

NCT05203003

APHP210482

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

260 participants in 1 patient group

Adult patients who are included in the CONFIRM phase III trial

Treatment:

Other: Assessment of MRD