RecruitingPhase 4NCT06251076

Plan Development for Giving Teclistamab in the Outpatient Setting

Outpatient-based Teclistamab Step-up Dosing in Patients With Relapsed/Refractory Multiple Myeloma: Process Development in Academic and Community Centres, and Evaluating Impact on Caregiver Burden

Sponsor

University Health Network, Toronto

Enrollment

15 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Refractory Cancer Relapsed Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study develops and refines a plan to give the multiple myeloma drug teclistamab (a bispecific T-cell engager antibody) in the outpatient setting rather than requiring hospital admission. The goal is to make this effective cancer treatment more convenient and accessible. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory multiple myeloma (a blood cancer that has come back or stopped responding to treatment) - You have received at least 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody - Your cancer has progressed on your most recent treatment - You are willing to receive treatment at Princess Margaret Cancer Centre or Stronach Regional Cancer Centre **You may NOT be eligible if...** - You have not tried at least 3 prior treatment regimens - You are unable or unwilling to attend the specified cancer centres - You do not meet Health Canada's approved criteria for teclistamab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeclistamab

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.

DRUGTocilizumab

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.