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.
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Department of Hematology, Hospital Saint Antoine
RECRUITING
Paris
Contact Information
Primary
Mohamad MOHTY, PUPH
mohamad.mohty@inserm.fr
+ 33 149 28 26 20
Backup
Florent MALARD, MD
malardf@yahoo.fr
+33 149 28 09 68
Time Frame
Start Date: 2022-04-22
Estimated Completion Date: 2028-12
Participants
Target number of participants: 260
Treatments
Adult patients who are included in the CONFIRM phase III trial
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris