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Taking people in FranceNo phase

Tracking residual myeloma cells after stopping daratumumab treatment

Studies whether stopping daratumumab, lenalidomide and dexamethasone after 2 years affects residual myeloma cells.

Plain-language title generated from the registry record
Registry title: 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.

Key facts

Where
Paris, FranceSee the site

Where in France

  • Department of Hematology, Hospital Saint AntoineParis, FranceTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Assistance Publique - Hôpitaux de Paris
Trial code
NCT05203003
Record updated
6 December 2024
Original description
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.Read full original descriptionShow less

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.

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.

Inclusion: 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: None.

ClinicalTrials.gov NCT05203003