Evaluating the impact of treatment duration on measurable residual disease in multiple myeloma patients
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.
This study looks at how stopping treatment after two years affects the health of people with relapsed multiple myeloma who have shown no signs of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05203003 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prognostic significance of measurable residual disease (MRD) in patients with relapsed multiple myeloma who have undergone either fixed duration or continuous therapy with daratumumab, lenalidomide, and dexamethasone. It focuses on patients who have achieved MRD negativity at the two-year mark and evaluates the effects of discontinuing therapy after this period. The study is observational and will analyze data from participants enrolled in the CONFIRM phase III trial.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who are part of the CONFIRM trial and have achieved complete response and MRD negativity at two years.
Not a fit: Patients who do not meet the eligibility criteria or are not part of the CONFIRM trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal duration of therapy for improving long-term outcomes in multiple myeloma patients.
How similar studies have performed: While this study builds on existing knowledge of MRD in multiple myeloma, the specific evaluation of treatment duration's impact on MRD persistence is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Department of Hematology, Hospital Saint Antoine — Paris, France (Recruiting)
Study contacts
- Principal investigator: Mohamad MOHTY, PUPH — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Mohamad MOHTY, PUPH
- Email: mohamad.mohty@inserm.fr
- Phone: + 33 149 28 26 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.