Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 18
Summary
- Conditions
- Plasma Cell Myeloma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The duration of the study for an individual patient will include: A period to assess eligibility (screening or baseline period) of up to 3 weeks for VCDI cohort, up to 28 days for VRDI cohort; for patients in the VCDI cohort: a treatment period including up to 12 induction treatment cycles (50-week ...
The duration of the study for an individual patient will include: A period to assess eligibility (screening or baseline period) of up to 3 weeks for VCDI cohort, up to 28 days for VRDI cohort; for patients in the VCDI cohort: a treatment period including up to 12 induction treatment cycles (50-week duration). for patients in the VRDI cohort: a treatment period including up to 4 induction cycles (24 week duration). Following induction, both cohorts have maintenance periods consisting of 4 week cycles until progression, unacceptable AE, or patient willingness to discontinue and an end-of-treatment visit at least 30 days following the last administration of treatment. Patients that discontinue therapy for reasons other than progression will have follow-up visits until progression or until the patient receives another anticancer therapy, whichever is earlier.
Tracking Information
- NCT #
- NCT02513186
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Sciences & Operations Sanofi
Get Well Soon