Multiple Myeloma
Conditions
Keywords
multiple myeloma, measurable residual disease, daratumumab, lenalidomide, dexamethasone
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.
Interventions
OTHERAssessment of MRD
Bone marrow aspirate for assessment of MRD will be performed at 2 years (+/- 3 month) after randomization in patients still under treatment and in complete response. Thereafter, bone marrow aspirate for assessment of MRD will be repeated at 3 and 4 years in patients that maintain complete response, irrespective of the randomization arm and therefore of treatment administration.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients that maintain MRD negativity | 3 and 4 years after inclusion | 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
| Measure | Time frame | Description |
|---|---|---|
| PFS at 2 years | 2 years | 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. |
Countries
France
Contacts
Primary ContactMohamad MOHTY, PUPH
Backup ContactFlorent MALARD, MD
Outcome results
None listed