NCT07589634RecruitingPhase 2
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 11 May 2026
- Start date
- 30 Jun 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT07589634
- EudraCT number
- 2025-524793-42
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 230
- From 30 Jun 2026 to the primary completion date, 31 Dec 2027
- 60 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Alexander Fleming Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital Alemán Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital Privado Centro Medico de Cordoba Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Hospital Universitario Austral Coordinator of this site? Confirm its status | Pilar | Argentina | Recruiting |
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Recruiting |
| Sunshine Coast University Hospital Coordinator of this site? Confirm its status | Birtinya | Australia | Recruiting |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Recruiting |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Wollongong Hospital Coordinator of this site? Confirm its status | Wollongong | Australia | Recruiting |
| Hosp. de La Santa Creu I Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hosp. de Leon Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| Hosp. Univ. La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp. Blua Sanitas Valdebebas Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hosp Regional Univ de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hosp. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hosp. Univ. Dr. Peset Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil | France | Recruiting |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| CHU de Grenoble Coordinator of this site? Confirm its status | La Tronche | France | Recruiting |
| Centre de Cancérologie de la Sarthe Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
| CHU Nantes-Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier de Quimper Cornouaille Coordinator of this site? Confirm its status | Quimper | France | Recruiting |
| Uni General Hospital of Alexandroupolis Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Recruiting |
| Alexandra General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| 251 Air Force General Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Metaxa Cancer Center Hospital Of Piraeus Coordinator of this site? Confirm its status | Piraeus | Greece | Recruiting |
| General University Hospital of Patras Coordinator of this site? Confirm its status | Rio | Greece | Recruiting |
| Hippokration Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Pécsi Tudományegyetem Klinikai Központ Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Hospital Ampang Coordinator of this site? Confirm its status | Ampang | Malaysia | Recruiting |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | George Town | Malaysia | Recruiting |
| Hospital Sultanah Aminah Coordinator of this site? Confirm its status | Johor Bharu | Malaysia | Recruiting |
| Hospital Queen Elizabeth Coordinator of this site? Confirm its status | Kota Kinabalu | Malaysia | Recruiting |
| Sarawak General Hospital Coordinator of this site? Confirm its status | Kuching | Malaysia | Recruiting |
| Uls Braga - Hosp. Braga Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| IPO Lisboa Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Hosp. Cuf Descobertas Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Uls Sao Joao - Hosp. Sao Joao Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Uls Santo Antonio - Hosp. Santo Antonio Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Uls Gaia Espinho Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
| Falu Lasarett Medicinkliniken Falun Coordinator of this site? Confirm its status | Falun | Sweden | Recruiting |
| Sahlgrenska Universitetssjukhuset Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Skanes universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Akademiska sjukhuset Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
| Beverly Hills Cancer Center (BHCC) Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Ohio Health Research Institute Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| City of Hope - Phoenix Coordinator of this site? Confirm its status | Goodyear | United States | Recruiting |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.