Study on Using Tocilizumab to Prevent Cytokine Release Syndrome in Patients with Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT07589634
This clinical trial is testing whether a single dose of tocilizumab can help prevent or lessen the severity of cytokine release syndrome (CRS) when given before the treatment ramantamig in patients with relapsed or refractory multiple myeloma.
Patient Parameters
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Program Overview
The aim of this study is to determine if giving tocilizumab before starting treatment with ramantamig can prevent or reduce the severity of cytokine release syndrome (CRS) in patients with relapsed or refractory multiple myeloma. CRS is a reaction that can happen during treatment, causing symptoms like fever and tiredness. The study will compare the effects of tocilizumab with a placebo over a period of 28 days.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma (MM) based on specific medical criteria.
- Have measurable disease as determined by lab tests.
- Have received at least one previous treatment for multiple myeloma.
- Have relapsed or refractory disease, meaning the cancer has returned after treatment or did not respond to previous treatments.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities, unless the score is due to stable physical limitations not related to multiple myeloma.
- Meet specific lab test criteria before starting the study treatment.
Exclusion Criteria
- Currently using any other cancer treatment or investigational drugs.
- Have had major surgery within two weeks before the first dose or have not fully recovered from surgery.
- Have known allergies or intolerances to ramantamig or tocilizumab.
- Have any ongoing blood disorders or other cancers besides multiple myeloma that require systemic treatment.
- Have known or suspected involvement of the central nervous system by multiple myeloma, unless cleared by specific tests.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Beverly Hills Cancer Center (BHCC) | 90211 | Beverly Hills | California |
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