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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.
RECRUITINGSponsored by Assistance Publique - Hôpitaux de Paris
Actively Recruiting
SponsorAssistance Publique - Hôpitaux de Paris
Started2022-04-22
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05203003
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
CancerMultiple Myeloma
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Actively Recruiting
SponsorAssistance Publique - Hôpitaux de Paris
Started2022-04-22
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05203003