NCT06055075

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Forimtamig	Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.
DRUG	Carfilzomib	Carfilzomib will be administered via IV infusion in combination with forimtamig.
DRUG	Daratumumab	Daratumumab will be administered via SC injection in combination with forimtamig.

Timeline

• Start date: 2023-12-12
• Primary completion: 2025-07-08
• Completion: 2025-07-08
• First posted: 2023-09-26
• Last updated: 2025-07-14

Locations

7 sites across 6 countries: Australia, Canada, Italy, New Zealand, South Korea, Spain

Regulatory

• FDA-regulated drug study