A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
On this site
📄 Actemra (tocilizumab) drug profile →More Janssen Research & Development, LLC trials in the USA
Other trials for the same condition
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