Interventional Recruiting Phase 2
NCT06758375 on ClinicalTrials.gov
Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
Official title: Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.
- Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
- Enrollment: 10 (Estimated)
- Study start: 2025-03-03 (Actual)
- Primary completion: 2026-09-07 (Estimated)
- Study completion: 2026-12-01 (Estimated)
- Allocation: N/a
- InterventionModel: Single Group
- InterventionModelDescription: One arm, open-label, phase 2 study
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.
Conditions
- Multiple Myeloma, Newly Diagnosed
Intervention / Treatment
- Drug: Low-dose teclistamab
Primary Outcome Measures
-
To determine general response
(18 months after last teclistamab dose)
Evaluated according to the IMWG response criteria including MRD status.
Countries
Mexico
Locations and Investigators
- Hospital Universitario Dr. Jose E. Gonzalez, Monterrey, Mexico (Recruiting)