NCT06758375

Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients

Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This single-arm, open-label study aims to determine the efficacy and safety of low-dose (1.0 mg/kg), limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients after 3 (three) VRd cycles as induction therapy. Patients with MMND who meet the established inclusion criteria will be invited to participate. A single-arm phase 2 study will be conducted in the Hematology Department of the University Hospital, where an induction schedule of 3 cycles of bortezomib, lenalidomide, and dexamethasone (VRd) will be administered followed by consolidation with 4 therapeutic doses of teclistamab at 1.0 mg/kg subcutaneously. Four weeks after the last dose of teclistamab, the clinical response will be assessed according to standard International Myeloma Working Group (IMWG) criteria. Those with a complete response (CR) or better will be assessed for measurable residual disease (MRD) with multiparametric flow cytometry with a sensitivity of 10\^6. Patients with CR and negative MRD will be kept under active surveillance for 18 months, while those with positive MRD or high cytogenetic risk will be offered biweekly bortezomib as maintenance. On the other hand, patients with very good partial response (VGPR) or worse will be offered 1-2 additional therapeutic doses of teclistamab and reevaluated 4 weeks after the last dose. Finally, patients who do not achieve CR will exit the study and will continue their management according to the standard of care recommended by their treating physician.

Conditions

• Multiple Myeloma, Newly Diagnosed

Interventions

Type	Name	Description
DRUG	Low-dose teclistamab	NDMM patients will receive VRd 3x cicles followed by low dose teclistamab.

Timeline

• Start date: 2025-03-03
• Primary completion: 2026-09-07
• Completion: 2026-12-01
• First posted: 2025-01-03
• Last updated: 2025-03-20

Locations

1 site across 1 country: Mexico