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

COMPLETEDPHASE1/PHASE2

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

NCT06055075•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Life expectancy of at least 12 weeks
•Documented diagnosis of MM according to the IMWG diagnostic criteria
•Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen
•Measurable disease
•AEs from prior anti-cancer therapy resolved to Grade ≤ 1,
•Adequate organ functions

Exclusion Criteria

•Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug
•Plasma cell leukemia with circulating plasma cell count ≥ 5% or \>500/microliter (µL)
•Participants with known amyloidosis
•Participants with myelodysplastic syndrome
•Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter
•Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration
•Prior solid organ transplantation
•Active auto-immune disease or flare within 6 months prior to start of study treatment
•Known or suspected chronic active Epstein-Barr virus (EBV) infection
•Hepatitis B virus (HBV) infection
+8 more criteria

Locations (7)

Princess Alexandra Hospital Woolloongabba

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Hamilton Health Sciences

Hamilton, Ontario, Canada

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

New Zealand Clinical Research - Auckland

Auckland, New Zealand

Seoul St Mary's Hospital

Seoul, South Korea

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Key Dates

Start Date

December 12, 2023

Primary Completion Date

July 8, 2025

Completion Date

July 8, 2025

Last Updated

July 14, 2025

Enrollment

ACTUAL participants

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

Forimtamig

DRUG

Carfilzomib

DRUG

Daratumumab

DRUG

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

NCT07138209

Relapsed or Refractory Multiple Myeloma

View study

RECRUITINGPHASE1

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

NCT05913804

Relapsed or Refractory Multiple Myeloma

View study

RECRUITINGNA

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma