Plan Development for Giving Teclistamab in the Outpatient Setting
NCT06251076 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-12-10
Summary
This is a pilot study to develop an outpatient-based process for the administration of teclistamab for for relapsed/refractory multiple myeloma patients and to evaluate the burden on caregivers of patients receiving outpatient administration of teclistamab.
Conditions
- Multiple Myeloma
- Relapsed Cancer
- Refractory Cancer
Interventions
- DRUG
-
Teclistamab is an antibody therapy (bispecific T-cell engager \[BiTE\]) that binds to two target proteins on different cells; CD3 on healthy T cells and B cell maturation antigen (BCMA) on myeloma cells. This brings healthy T cells and the myeloma cells close together so the T cells can more effectively kill them. Teclistamab is approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
- DRUG
-
Toclilzumab is an interleukin inhibitor approved for the treatment of patients with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) and other indications.
Sponsors & Collaborators
-
Janssen Inc.
collaborator INDUSTRY -
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Christine Chen, Dr. · University Health Network, Toronto
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-19
- Primary Completion
- 2026-06-15
- Completion
- 2026-10-31
Countries
- Canada
Study Locations
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