NCT05203003 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Multiple Myeloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2022-04-22 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2022-04-22 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Mohamad MOHTY, PUPH
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05203003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05203003 currently recruiting?
Yes, NCT05203003 is actively recruiting participants. Contact the research team at mohamad.mohty@inserm.fr for enrollment information.
Where is the NCT05203003 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05203003 clinical trial?
NCT05203003 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Mohamad MOHTY, PUPH at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 260 participants.