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RECRUITING
NCT07589634
PHASE2

A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo. CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.

Official title: 79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2026-06-30

Completion Date

2030-11-08

Last Updated

2026-08-28

Healthy Volunteers

No

Interventions

DRUG

Ramantamig

Ramantamig will be administered as subcutaneous (SC) injection.

DRUG

Tocilizumab

Tocilizumab will be administered as intravenous (IV) injection.

DRUG

Placebo

Placebo (saline) will be administered as IV injection.

Locations (9)

Beverly Hills Cancer Center (BHCC)

Beverly Hills, California, United States

Hospital Aleman

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Concord Repatriation General Hospital

Concord, Australia

Hospital Ampang

Ampang, Malaysia

Hospital Sultanah Aminah

Johor Bharu, Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia

Sarawak General Hospital

Kuching, Malaysia