A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07589634
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ramantamig — DRUG
    Ramantamig will be administered as subcutaneous (SC) injection.
  • Tocilizumab — DRUG
    Tocilizumab will be administered as intravenous (IV) injection.
  • Placebo — DRUG
    Placebo (saline) will be administered as IV injection.

Study Details

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.

Key Dates

Start date
Jul 20, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Nov 8, 2030

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm A: Tocilizumab + Ramantamig
    Participants will receive tocilizumab alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).
  • Placebo Comparator: Arm B: Placebo + Ramantamig
    Participants will receive placebo (saline) alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).

Primary Outcome Measure

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) [ Time Frame: End of Day 28 from ramantamig dose ]

Central Contacts

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