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

NCT07589634 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: 79635322MMY20022025-524793-422025
• Study Type: interventional
• Target: 230
• Locations: 9 countries
• Sites: 38

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Alive and Free of Treatment-Emergent American Society for Transplantation and Cellular Therapy (ASTCT) Grade Greater Than or Equal to (>=) 2 Cytokine Release Syndrome (CRS)

  Percentage of participants alive and free of treatment-emergent ASTCT Grade \>=2 CRS without the use of intervening treatment for CRS of any grade by the end of day 28 from first ramantamig dose will be reported.

  By the end of Day 28 from first ramantamig dose

Secondary Outcomes (14)

• Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from First Ramantamig Dose

  By the end of Day 28 from first ramantamig dose

• Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment

  Up to 38 months

• Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event

  Up to 38 months

• Percentage of Participants with Re-occurrence of CRS for All Grades

  Up to 38 months

• Overall Response

  Up to 38 months

Study Arms (2)

Arm A: Tocilizumab + Ramantamig

EXPERIMENTAL

Participants will receive tocilizumab along with ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).

Drug: Ramantamig; Drug: Tocilizumab

Arm B: Placebo + Ramantamig

PLACEBO COMPARATOR

Participants will receive placebo (saline) along with ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).

Drug: Ramantamig; Drug: Placebo

Interventions

Ramantamig DRUG

Ramantamig will be administered as subcutaneous (SC) injection.

Also known as: JNJ-79635322

Arm A: Tocilizumab + Ramantamig; Arm B: Placebo + Ramantamig

Tocilizumab DRUG

Tocilizumab will be administered as intravenous (IV) injection.

Arm A: Tocilizumab + Ramantamig

Placebo DRUG

Placebo (saline) will be administered as IV injection.

Arm B: Placebo + Ramantamig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (38)

City of Hope Phoenix

Goodyear, Arizona, 85338, United States

RECRUITING

Beverly Hills Cancer Center (BHCC)

Beverly Hills, California, 90211, United States

RECRUITING

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Hospital Aleman

Buenos Aires, C1118, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB, Argentina

RECRUITING

Instituto Alexander Fleming

Buenos Aires, C1426ANZ, Argentina

RECRUITING

Hospital Privado Centro Medico de Cordoba

Córdoba, X5016KEH, Argentina

RECRUITING

Concord Repatriation General Hospital

Concord, 2139, Australia

RECRUITING

Wollongong Hospital

Wollongong, 2500, Australia

RECRUITING

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

RECRUITING

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

RECRUITING

Centre de Cancerologie de la Sarthe

Le Mans, 72100, France

RECRUITING

CHU Nantes - Hotel Dieu

Nantes, 44000, France

RECRUITING

Uni General Hospital of Alexandroupolis

Alexandroupoli, 681 00, Greece

RECRUITING

251 Air Force General Hospital

Athens, 115 25, Greece

RECRUITING

Alexandra General Hospital of Athens

Athens, 11528, Greece

RECRUITING

General University Hospital of Patras

Rio, 265 04, Greece

RECRUITING

Theageneio Cancer Hospital

Thessaloniki, 546 39, Greece

RECRUITING

Hippokration Hospital

Thessaloniki, 54642, Greece

RECRUITING

Hospital Ampang

Ampang, 68000, Malaysia

RECRUITING

Hospital Pulau Pinang

George Town, 10450, Malaysia

RECRUITING

Hospital Sultanah Aminah

Johor Bharu, 80100, Malaysia

RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, 88586, Malaysia

RECRUITING

Sarawak General Hospital

Kuching, 93586, Malaysia

RECRUITING

Uls Braga - Hosp. Braga

Braga, 4710 243, Portugal

RECRUITING

Hosp. Cuf Descobertas

Lisbon, 1998 018, Portugal

RECRUITING

Uls Santo Antonio - Hosp. Santo Antonio

Porto, 4050 342, Portugal

RECRUITING

Uls Sao Joao - Hosp. Sao Joao

Porto, 4200 319, Portugal

RECRUITING

Hosp. Univ. La Paz

Madrid, 28046, Spain

RECRUITING

Hosp. de Navarra

Pamplona, 31008, Spain

RECRUITING

Hosp. Univ. Dr. Peset

Valencia, 46017, Spain

RECRUITING

Falu Lasarett Medicinkliniken Falun

Falun, 791 82, Sweden

RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

RECRUITING

Skanes universitetssjukhus

Lund, 221 85, Sweden

RECRUITING

Karolinska University Hospital Huddinge

Stockholm, 141 86, Sweden

RECRUITING

Akademiska Sjukhuset

Uppsala, 752 37, Sweden

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): November 8, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (5); MY (5); AR (4); AU (2); PT (4); ES (3); SE (5); FR (4); GR (6)