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.

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.

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: April 2027

Interventions

• Other: Assessment of MRD
  • Bone marrow aspirate for assessment of MRD will be performed at 2 years (+/- 3 month) after randomization in patients still under treatment and in complete response. Thereafter, bone marrow aspirate for assessment of MRD will be repeated at 3 and 4 years in patients that maintain complete response, irrespective of the randomization arm and therefore of treatment administration.

Arms, Groups and Cohorts

• Adult patients who are included in the CONFIRM phase III trial

Clinical Trial Outcome Measures

Primary Measures

• Rate of patients that maintain MRD negativity
  • Time Frame: 3 and 4 years after inclusion
  • Rate of patients that maintain MRD negativity at 3 and 4 years after inclusion in the current protocol in the continuous Dara-Len-Dex therapy group versus fixed duration Dara-Len-Dex therapy (2 years) group.

Secondary Measures

• PFS at 2 years
  • Time Frame: 2 years
  • PFS at 2 years after initial assessment of MRD negativity, which is defined as the duration from the date of MRD measurement to either progressive disease, according to the IMWG criteria, or death.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Assistance Publique – Hôpitaux de Paris
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Mohamad MOHTY, PUPH, Principal Investigator, Assistance Publique – Hôpitaux de Paris
• Overall Contact(s)
  • Mohamad MOHTY, PUPH, + 33 149 28 26 20, mohamad.mohty@inserm.fr