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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.

NCT ID: NCT05203003

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-22

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Keywords

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multiple myeloma measurable residual disease daratumumab lenalidomide dexamethasone

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients who are included in the CONFIRM phase III trial

Assessment of MRD

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamad MOHTY, PUPH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Department of Hematology, Hospital Saint Antoine

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mohamad MOHTY, PUPH

Role: CONTACT

Phone: + 33 149 28 26 20

Email: [email protected]

Florent MALARD, MD

Role: CONTACT

Phone: +33 149 28 09 68

Email: [email protected]

Facility Contacts

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Mohamad MOHTY, PU-PH

Role: primary

Florent MALARD, MD

Role: backup

Other Identifiers

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APHP210482

Identifier Type: -

Identifier Source: org_study_id