Phase 2 Study of Tocilizumab to Prevent Cytokine Release Syndrome During Ramantamig Treatment in Adults With Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are investigating whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce cytokine release syndrome CRS in people with relapsed or refractory multiple myeloma. CRS is an inflammatory reaction that can happen during treatment and may cause symptoms like fever and tiredness. This Phase 2 study aims to compare tocilizumab plus ramantamig versus placebo plus ramantamig to see the impact on CRS severity within 28 days after ramantamig administration. Participants will be randomly assigned to receive tocilizumab intravenously along with ramantamig given as a subcutaneous injection, or a placebo intravenous injection with ramantamig. Ramantamig treatment will continue for a set time or until disease progression or intolerable side effects occur. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives tocilizumab or placebo during the trial. During the study, participants will be monitored closely for signs of CRS and other responses to treatment. Researchers will assess the presence and severity of CRS within 28 days and track outcomes like response rates, progression-free survival, and adverse events for up to around 3 years and 6 months. Safety, laboratory tests, and clinical evaluations will be conducted regularly to understand treatment effects and participant well-being over the study duration.

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