Tests tocilizumab to prevent a reaction during ramantamig treatment in myeloma
Tests whether tocilizumab before ramantamig helps prevent cytokine release syndrome in adults with myeloma.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
Key facts
- Where
- Argenteuil, Bayonne, La Tronche, Le Mans, Nantes, and Quimper, FranceSee the 6 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which of these best describes your myeloma treatment so far?
- Has a doctor told you that your myeloma can be measured in your blood or urine tests?
- Has a doctor told you that you have myeloma in the brain or in the fluid and membranes around the brain and spinal cord, now or in the past?
Source: NCT07589634, who can take part
Where in France
- Centre Hospitalier Victor DupouyArgenteuil, FranceTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranceTaking people
- CHU de GrenobleLa Tronche, FranceTaking people
- Centre de Cancérologie de la SartheLe Mans, FranceTaking people
- CHU Nantes-Hotel DieuNantes, FranceTaking people
- Centre Hospitalier de Quimper CornouailleQuimper, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07589634
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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.