NCT05572229

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Teclistamab	Teclistamab will be administered via a subcutaneous injection (SC)
DRUG	Daratumumab	Daratumumab will be administered via a subcutaneous injection (SC)
DRUG	Lenalidomide	Lenalidomide will be administered orally

Timeline

• Start date: 2023-12-21
• Primary completion: 2026-04-01
• Completion: 2030-09-01
• First posted: 2022-10-07
• Last updated: 2025-09-17

Locations

29 sites across 1 country: France