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A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma
Clinicaltrials.gov:
EudraCT:
Other:
#79635322MMY2002
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Trials at a glance
Status
Enrolling
Condition
Multiple Myeloma
Trial type
Interventional
Trial phase
Phase 2
Investigational
product
product
Placebo
Ramantamig
Tocilizumab
Age
18+ years old
Biological sex
All
Placebo?
Yes
Trial start date
July 20, 2026
Trial end date
November 8, 2030
CT.gov ID
#NCT07589634
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A 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.
Primary outcome measures
- 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)
Secondary outcome measures
- Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from Ramantamig Dose
- Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
- 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 for All Grades
- Overall Response Rate (ORR)
- Complete Response (CR) or Better
- Very Good Partial Response (VGPR) or Better
- Duration of Response (DoR)
- Time to Response (TTR)
- Progression-Free Survival (PFS)
- Time To Next Line of Therapy (TTNT)
- Time to the First Treatment-emergent Infection with Toxicity Grade >=3
- Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
- Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
- Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
- Percentage of Participants with Abnormalities in Laboratory Parameters
- Percentage of Participants with Incidence of Adverse Events of Clinical Interests
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