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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma who are already in the CONFIRM phase III trial, are still on treatment 2 years after randomization, and are in complete response.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Multiple myeloma in complete response at 2 years (+/- 3 months) after randomization in the CONFIRM trial.
- Earlier treatment
- Must be included in the CONFIRM phase III trial (NCT03836014) and still on therapy at 2 years (+/- 3 months) after randomization, in either the fixed duration or the continuous therapy group.
Main reasons for not taking part
- The record lists no exclusion criteria.
Read by machine on 9 November 2026.
Where in France
- Department of Hematology, Hospital Saint AntoineParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.