RECRUITING Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07589634

Registry updated: 2026-10-01

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Description

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.

Interventions

Ramantamig (Drug)
Ramantamig will be administered as subcutaneous (SC) injection.
Tocilizumab (Drug)
Tocilizumab will be administered as intravenous (IV) injection.
Placebo (Drug)
Placebo (saline) will be administered as IV injection.

Eligibility criteria

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

Conditions

Multiple Myeloma

Locations

City of Hope Phoenix — Goodyear, Arizona, United States
Beverly Hills Cancer Center (BHCC) — Beverly Hills, California, United States
City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
Colorado Blood Cancer Institute — Denver, Colorado, United States
Washington University School Of Medicine — St Louis, Missouri, United States
Hospital Aleman — Buenos Aires, Argentina
Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
Instituto Alexander Fleming — Buenos Aires, Argentina
Hospital Privado Centro Medico de Cordoba — Córdoba, Argentina
Concord Repatriation General Hospital — Concord, Australia
Wollongong Hospital — Wollongong, Australia
Centre Hospitalier Victor Dupouy — Argenteuil, France
Centre Hospitalier de la Cote Basque — Bayonne, France
Centre de Cancerologie de la Sarthe — Le Mans, France
CHU Nantes - Hotel Dieu — Nantes, France
Uni General Hospital of Alexandroupolis — Alexandroupoli, Greece
251 Air Force General Hospital — Athens, Greece
Alexandra General Hospital of Athens — Athens, Greece
General University Hospital of Patras — Rio, Greece
Theageneio Cancer Hospital — Thessaloniki, Greece
Hippokration Hospital — Thessaloniki, Greece
Hospital Ampang — Ampang, Malaysia
Hospital Pulau Pinang — George Town, Malaysia
Hospital Sultanah Aminah — Johor Bharu, Malaysia
Hospital Queen Elizabeth — Kota Kinabalu, Malaysia
Sarawak General Hospital — Kuching, Malaysia
Uls Braga - Hosp. Braga — Braga, Portugal
Hosp. Cuf Descobertas — Lisbon, Portugal
Uls Santo Antonio - Hosp. Santo Antonio — Porto, Portugal
Uls Sao Joao - Hosp. Sao Joao — Porto, Portugal
Hosp. Univ. La Paz — Madrid, Spain
Hosp. de Navarra — Pamplona, Spain
Hosp. Univ. Dr. Peset — Valencia, Spain
Falu Lasarett Medicinkliniken Falun — Falun, Sweden
Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden
Skanes universitetssjukhus — Lund, Sweden
Karolinska University Hospital Huddinge — Stockholm, Sweden
Akademiska Sjukhuset — Uppsala, Sweden

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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