Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

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: 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

2030-07-30

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Multiple Myeloma

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.

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

Locations (60)

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

Stanford University Medical Center

Palo Alto, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 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

Hospital Universitario Austral

Pilar, Argentina

Flinders Medical Centre

Bedford Park, Australia

Sunshine Coast University Hospital

Birtinya, Australia

Concord Repatriation General Hospital

Concord, Australia

St Vincents Hospital Melbourne

Fitzroy, Australia

Wollongong Hospital

Wollongong, Australia

Centre Hospitalier Victor Dupouy

Argenteuil, France

Centre Hospitalier de la Cote Basque

Bayonne, France

CHU de Grenoble

La Tronche, France

Centre de Cancerologie de la Sarthe

Le Mans, France

CHU Nantes - Hotel Dieu

Nantes, France

Centre Hospitalier de Quimper Cornouaille

Quimper, France

Uni General Hospital of Alexandroupolis

Alexandroupoli, Greece

251 Air Force General Hospital

Athens, Greece

Alexandra General Hospital of Athens

Athens, Greece

Metaxa Cancer Center Hospital Of Piraeus

Piraeus, Greece

General University Hospital of Patras

Rio, Greece

Theageneio Cancer Hospital

Thessaloniki, Greece

Hippokration Hospital

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Hungary

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Szeged, Hungary

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

Ipo Lisboa

Lisbon, Portugal

Hosp. Cuf Descobertas

Lisbon, Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, Portugal

Uls Sao Joao - Hosp. Sao Joao

Porto, Portugal

Uls Gaia Espinho

Vila Nova de Gaia, Portugal

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp. de Leon

León, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Blua Sanitas Valdebebas

Madrid, Spain

Hosp Regional Univ de Malaga

Málaga, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (60)