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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
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

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Alexander Fleming
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Buenos AiresArgentinaRecruiting
Hospital Alemán
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Buenos AiresArgentinaRecruiting
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaRecruiting
Hospital Privado Centro Medico de Cordoba
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CórdobaArgentinaRecruiting
Hospital Universitario Austral
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PilarArgentinaRecruiting
Flinders Medical Centre
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Bedford ParkAustraliaRecruiting
Sunshine Coast University Hospital
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BirtinyaAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
St Vincents Hospital Melbourne
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FitzroyAustraliaRecruiting
Wollongong Hospital
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WollongongAustraliaRecruiting
Hosp. de La Santa Creu I Sant Pau
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BarcelonaSpainRecruiting
Hosp. de Leon
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LeónSpainRecruiting
Hosp. Univ. La Paz
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MadridSpainRecruiting
Hosp. Blua Sanitas Valdebebas
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MadridSpainRecruiting
Hosp Regional Univ de Malaga
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MálagaSpainRecruiting
Hosp. de Navarra
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PamplonaSpainRecruiting
Hosp. Univ. Dr. Peset
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ValenciaSpainRecruiting
Centre Hospitalier Victor Dupouy
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ArgenteuilFranceRecruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceRecruiting
CHU de Grenoble
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La TroncheFranceRecruiting
Centre de Cancérologie de la Sarthe
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Le MansFranceRecruiting
CHU Nantes-Hotel Dieu
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NantesFranceRecruiting
Centre Hospitalier de Quimper Cornouaille
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QuimperFranceRecruiting
Uni General Hospital of Alexandroupolis
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AlexandroupoliGreeceRecruiting
Alexandra General Hospital of Athens
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AthensGreeceRecruiting
251 Air Force General Hospital
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AthensGreeceRecruiting
Metaxa Cancer Center Hospital Of Piraeus
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PiraeusGreeceRecruiting
General University Hospital of Patras
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RioGreeceRecruiting
Hippokration Hospital
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ThessalonikiGreeceRecruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceRecruiting
Orszagos Onkologiai Intezet
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BudapestHungaryRecruiting
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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BudapestHungaryRecruiting
Semmelweis Egyetem
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BudapestHungaryRecruiting
Pécsi Tudományegyetem Klinikai Központ
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PécsHungaryRecruiting
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
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SzegedHungaryRecruiting
Hospital Ampang
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AmpangMalaysiaRecruiting
Hospital Pulau Pinang
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George TownMalaysiaRecruiting
Hospital Sultanah Aminah
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Johor BharuMalaysiaRecruiting
Hospital Queen Elizabeth
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Kota KinabaluMalaysiaRecruiting
Sarawak General Hospital
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KuchingMalaysiaRecruiting
Uls Braga - Hosp. Braga
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BragaPortugalRecruiting
IPO Lisboa
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LisbonPortugalRecruiting
Hosp. Cuf Descobertas
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LisbonPortugalRecruiting
Uls Sao Joao - Hosp. Sao Joao
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PortoPortugalRecruiting
Uls Santo Antonio - Hosp. Santo Antonio
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PortoPortugalRecruiting
Uls Gaia Espinho
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Vila Nova de GaiaPortugalRecruiting
Falu Lasarett Medicinkliniken Falun
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FalunSwedenRecruiting
Sahlgrenska Universitetssjukhuset
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GothenburgSwedenRecruiting
Skanes universitetssjukhus
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LundSwedenRecruiting
Karolinska University Hospital Huddinge
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StockholmSwedenRecruiting
Akademiska sjukhuset
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UppsalaSwedenRecruiting
Beverly Hills Cancer Center (BHCC)
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Beverly HillsUnited StatesRecruiting
Ohio Health Research Institute
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ColumbusUnited StatesRecruiting
Colorado Blood Cancer Institute
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DenverUnited StatesRecruiting
City of Hope - Phoenix
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GoodyearUnited StatesRecruiting
City of Hope Orange County Lennar Foundation Cancer Center
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IrvineUnited StatesRecruiting
Sarah Cannon Research Institute
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NashvilleUnited StatesRecruiting
Stanford University Medical Center
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Palo AltoUnited StatesRecruiting
University of Utah - Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.