Plan Development for Giving Teclistamab in the Outpatient Setting

Sponsor
University Health Network, Toronto
Study ID
NCT06251076
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Teclistamab — 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.
  • Tocilizumab — 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.

Study Details

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.

Key Dates

Start date
Nov 19, 2024
Status verified
Dec 2025
Primary completion
Jun 15, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Give teclistamab step-up dosing at Princess Margaret Cancer Centre as per product monograph.
  • Experimental: Cohort 2
    Give teclistamab step-up dosing at Princess Margaret Cancer Centre with the addition of one dose of prophylactic tocilizumab prior to step-up dose 1.
  • Experimental: Cohort 3
    Give teclistamab step-up dosing at Southlake Regional Cancer Centre in the outpatient setting using the best method(s) as determined from Cohorts 1 and 2.
  • No Intervention: Caregiver Cohort
    Caregivers of participants in Cohorts 1, 2, and 3 will complete various questionnaires to assess impact.

Primary Outcome Measure

Median of day hospital encounters or hospitalizations as assessed by using descriptive statistics. [ Time Frame: 1 year ]

Central Contacts

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