A Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in ND-TEMM
NCT04786028 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-01-08
Summary
This is a phase II multi-center, open label, single arm study to evaluate the safety and efficacy of Isatuximab administered intravenously in combination with CyBorD induction treatment and Lenalidomide maintenance treatment in a 28-day long cycle in autologous stem cell transplant-eligible patients.
Conditions
Interventions
- OTHER
-
Isatuximab
Brand name for interventional drug is Sarclisa
Sponsors & Collaborators
-
Canadian Myeloma Research Group
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-08
- Primary Completion
- 2026-03-31
- Completion
- 2027-06-30
Countries
- Canada
Study Locations
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