Preventing Cytokine Release Syndrome with a single dose of tocilizumab before ramantamig in multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial tests whether giving one dose of tocilizumab before ramantamig can reduce the risk or severity of cytokine release syndrome within 28 days compared with placebo. Participants have relapsed or refractory multiple myeloma and have received at least one prior anti-myeloma therapy. The study compares ramantamig with either tocilizumab or placebo to see if the CRS outcome improves. Safety and tolerability are also monitored alongside treatment efficacy. Enrollment is at multiple U.S. centers.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; b. Measurable disease at screening as assessed by local laboratory as defined in the protocol
* Received at least 1 prior lines of antimyeloma therapy
* Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by the IMWG response criteria greater than (\>) 60 days after cessation of treatment.; b. Refractory disease is defined as failure to achieve a response or confirmed PD by the IMWG response criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment
* Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study treatment administration. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy
* Have clinical laboratory values meeting the criteria specified in the protocol

Exclusion criteria:

* Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
* Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients
* Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; c. Any active malignancy other than MM
* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Where it's running

• City of Hope Phoenix
  Goodyear, Arizona, United States Recruiting
• Beverly Hills Cancer Center (BHCC)
  Beverly Hills, California, United States Recruiting
• City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Stanford University Medical Center
  Palo Alto, California, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Washington University School Of Medicine
  St Louis, Missouri, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.