Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)

Conditions

• Relapsed/Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Linvoseltamab — DRUG
  Administered per the protocol
• Tocilizumab — DRUG
  Administered per the protocol

Study Details

This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody. The aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab. The study is looking at several other research questions, including: * What side effects may happen from taking tocilizumab before the first dose of linvoseltamab * Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last * How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed

Key Dates

First listed

May 27, 2026

Start date

Jul 15, 2026

Status verified

Jul 2026

Primary completion

Oct 11, 2027

Completion

Dec 6, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Linvoseltamab

Primary Outcome Measure

Occurrence of any grade CRS per American Society for Transplantation and Cellular Therapy (ASTCT) grading [ Time Frame: Up to 28 days ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (2)

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