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.

NCT05203003 | Recruiting

• 1 other identifier: APHP210482
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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 years.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; measurable residual disease; daratumumab; lenalidomide; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Rate of patients that maintain MRD negativity

  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.

  3 and 4 years after inclusion

Secondary Outcomes (1)

• PFS at 2 years

  2 years

Study Arms (1)

Adult patients who are included in the CONFIRM phase III trial

Other: Assessment of MRD

Interventions

Assessment of MRD OTHER

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.

Adult patients who are included in the CONFIRM phase III trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are included in the CONFIRM phase III trial

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Hematology, Hospital Saint Antoine

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamad MOHTY, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamad MOHTY, PUPH

CONTACT

+ 33 149 28 26 20; mohamad.mohty@inserm.fr

Florent MALARD, MD

CONTACT

+33 149 28 09 68; malardf@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: April 22, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)