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Recruiting Phase 2

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

NCT07589634 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-06-30
Last updated
2026-11-03

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Ramantamig →Tocilizumab →Placebo

Ramantamig: Ramantamig will be administered as subcutaneous (SC) injection.

Tocilizumab: Tocilizumab will be administered as intravenous (IV) injection.

Placebo: Placebo (saline) will be administered as IV injection.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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) — By the end of Day 28 from first ramantamig dose
    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.

Trial sites (60)

FacilityCityRegionStatus
City of Hope Phoenix Goodyear Arizona Recruiting
Beverly Hills Cancer Center (BHCC) Beverly Hills California Recruiting
City of Hope Orange County Lennar Foundation Cancer Center Irvine California Recruiting
Stanford University Medical Center Palo Alto California Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Washington University School Of Medicine St Louis Missouri Recruiting
Ohio Health Research Institute Columbus Ohio Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
University of Utah Huntsman Cancer Institute Salt Lake City Utah Recruiting
Hospital Aleman Buenos Aires Argentina Recruiting
Hospital Italiano de Buenos Aires Buenos Aires Argentina Recruiting
Instituto Alexander Fleming Buenos Aires Argentina Recruiting
Hospital Privado Centro Medico de Cordoba Córdoba Argentina Recruiting
Hospital Universitario Austral Pilar Argentina Recruiting
Flinders Medical Centre Bedford Park Australia Recruiting
Sunshine Coast University Hospital Birtinya Australia Recruiting
Concord Repatriation General Hospital Concord Australia Recruiting
St Vincents Hospital Melbourne Fitzroy Australia Recruiting
Wollongong Hospital Wollongong Australia Recruiting
Centre Hospitalier Victor Dupouy Argenteuil France Recruiting
Centre Hospitalier de la Cote Basque Bayonne France Recruiting
CHU de Grenoble La Tronche France Recruiting
Centre de Cancerologie de la Sarthe Le Mans France Recruiting
CHU Nantes - Hotel Dieu Nantes France Recruiting
Centre Hospitalier de Quimper Cornouaille Quimper France Recruiting
Uni General Hospital of Alexandroupolis Alexandroupoli Greece Recruiting
251 Air Force General Hospital Athens Greece Recruiting
Alexandra General Hospital of Athens Athens Greece Recruiting
Metaxa Cancer Center Hospital Of Piraeus Piraeus Greece Recruiting
General University Hospital of Patras Rio Greece Recruiting
Theageneio Cancer Hospital Thessaloniki Greece Recruiting
Hippokration Hospital Thessaloniki Greece Recruiting
Semmelweis Egyetem Budapest Hungary Recruiting
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely Budapest Hungary Recruiting
Orszagos Onkologiai Intezet Budapest Hungary Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont Pécs Hungary Recruiting
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szeged Hungary Recruiting
Hospital Ampang Ampang Malaysia Recruiting
Hospital Pulau Pinang George Town Malaysia Recruiting
Hospital Sultanah Aminah Johor Bharu Malaysia Recruiting

+ 20 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07589634 on ClinicalTrials.gov ↗ ← All trials in the USA