drugset / Trial / NCT05804032
Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma
Phase 3
Completed
514 enrolled
University of Heidelberg Medical Center
Deutsche Studiengruppe Multiples Myelom (DSMM) · collabKKS Netzwerk · collabSanofi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.
Timeline
- Start
- 2023-04-14
- Primary completion
- 2026-01-30
- Completion
- 2026-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isatuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Isatuximab | Monoclonal antibody | 1400 mg | Intravenous |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |