Clinical trial · Observational
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.
NCT05203003CI-TRIAL-00083407MRD-CONFIRMrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of MRD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult patients who are included in the CONFIRM phase III trial
- interventionNames
- Other: Assessment of MRD
Primary outcomes (1)
- measure
- Rate of patients that maintain MRD negativity
- timeFrame
- 3 and 4 years after inclusion
- description
- 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.
Secondary outcomes (1)
- measure
- PFS at 2 years
- timeFrame
- 2 years
- description
- PFS at 2 years after initial assessment of MRD negativity, which is defined as the duration from the date of MRD measurement to either progressive disease, according to the IMWG criteria, or death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.