About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ramantamig
DrugRamantamig will be administered as subcutaneous (SC) injection.
Tocilizumab
DrugTocilizumab will be administered as intravenous (IV) injection.
Placebo
DrugPlacebo (saline) will be administered as IV injection.
Treatment groups
Trial outcomes
Primary outcomes
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)
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.
Secondary outcomes
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from First Ramantamig Dose
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade \>=2, and Grade \>=3 by the end of day 28 from first ramantamig dose, respectively, will be reported.
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade \>=2, and Grade \>=3 during ramantamig treatment will be reported.
Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event
Percentage of participants with re-occurrence of CRS with ASTCT Grade \>=2 after the initial occurrence of treatment-emergent Grade \>=2 CRS event will be reported.
Percentage of Participants with Re-occurrence of CRS for All Grades
Percentage of participants with re-occurrence of CRS for all Grades will be reported.
Sponsors and contacts
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