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NCT07589634PHASE2Recruiting

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

Janssen Research & Development, LLC

Start Date

6/30/2026

Completion Date

11/8/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Ramantamig

DRUG

Tocilizumab

DRUG

Placebo

Interested in This Trial?

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Conditions

Multiple Myeloma

Locations

City of Hope Phoenix

Goodyear, Arizona 85338

United States

Beverly Hills Cancer Center (BHCC)

Beverly Hills, California 90211

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Washington University School Of Medicine

St Louis, Missouri 63110

United States

Hospital Aleman

Buenos Aires, C1118

Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB

Argentina

Instituto Alexander Fleming

Buenos Aires, C1426ANZ

Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, X5016KEH

Argentina

Concord Repatriation General Hospital

Concord, 2139

Australia

Wollongong Hospital

Wollongong, 2500

Australia

Centre Hospitalier Victor Dupouy

Argenteuil, 95107

France

Centre Hospitalier de la Cote Basque

Bayonne, 64100

France

Centre de Cancerologie de la Sarthe

Le Mans, 72100

France

CHU Nantes - Hotel Dieu

Nantes, 44000

France

Uni General Hospital of Alexandroupolis

Alexandroupoli, 681 00

Greece

251 Air Force General Hospital

Athens, 115 25

Greece

Alexandra General Hospital of Athens

Athens, 11528

Greece

General University Hospital of Patras

Rio, 265 04

Greece

Theageneio Cancer Hospital

Thessaloniki, 546 39

Greece

Hippokration Hospital

Thessaloniki, 54642

Greece

Hospital Ampang

Ampang, 68000

Malaysia

Hospital Pulau Pinang

George Town, 10450

Malaysia

Hospital Sultanah Aminah

Johor Bharu, 80100

Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, 88586

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

Uls Braga - Hosp. Braga

Braga, 4710 243

Portugal

Hosp. Cuf Descobertas

Lisbon, 1998 018

Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, 4050 342

Portugal

Uls Sao Joao - Hosp. Sao Joao

Porto, 4200 319

Portugal

Hosp. Univ. La Paz

Madrid, 28046

Spain

Hosp. de Navarra

Pamplona, 31008

Spain

Hosp. Univ. Dr. Peset

Valencia, 46017

Spain

Falu Lasarett Medicinkliniken Falun

Falun, 791 82

Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45

Sweden

Skanes universitetssjukhus

Lund, 221 85

Sweden

Karolinska University Hospital Huddinge

Stockholm, 141 86

Sweden

Akademiska Sjukhuset

Uppsala, 752 37

Sweden