Actively Recruiting
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
Led by University Health Network, Toronto · Updated on 2025-12-10
15
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
J
Janssen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring a new process for giving the antibody therapy teclistamab to adults with relapsed or refractory multiple myeloma in an outpatient setting. The study also aims to understand the burden on caregivers of patients receiving this outpatient treatment. This phase 4 pilot study focuses on developing safe and practical outpatient dosing methods for teclistamab, an approved treatment for patients who have tried multiple prior therapies and experienced disease progression. Participants will receive teclistamab with step-up dosing following product guidelines at different centers, including Princess Margaret Cancer Centre and Southlake Regional Cancer Centre. Some groups will receive an added dose of tocilizumab before the first step-up dose. Caregivers of patients in all treatment groups will complete questionnaires to assess how the outpatient treatment affects their quality of life and caregiving responsibilities. During the study, researchers will monitor hospital visits and treatment-related side effects for one year. Caregivers will report their quality of life using specific questionnaires over the same period. Participants will undergo regular assessments, including laboratory tests and vital sign monitoring. The study will also track toxicities and disease progression while collecting data on the outpatient dosing process and caregiver impact.
CONDITIONS
Brief Title
Plan Development for Giving Teclistamab in the Outpatient Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma
- Received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Demonstrated disease progression on the last therapy
- Agree to receive treatment at designated study centers depending on cohort
- Signed informed consent form
- Have one or more caregivers meeting study criteria
- Meet clinical laboratory value requirements
- Rockwood Clinical Frailty Scale score of 5 or less
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception or abstinence
- Women must agree not to donate eggs during the study
- Men must agree to use condoms and not donate sperm during the study
You will not qualify if you...
- Allergies or intolerance to study drugs or their ingredients
- Prior or current exposure to teclistamab or anti-BCMA therapies
- Recent use of other myeloma therapies within 3 days before first teclistamab dose
- Unresolved toxicities from prior anticancer treatments except alopecia or peripheral neuropathy
- High-risk disease features including CNS involvement, extramedullary disease, circulating plasma cells, or rapidly progressive disease
- Certain concurrent disorders such as light chain amyloidosis, active second malignancy requiring therapy (with exceptions), neurologic dysfunction, active hepatitis B infection without control, active infections requiring treatment, and coagulopathy
- Specific heart conditions including severe heart failure, recent heart attack or surgery, severe arrhythmias, or cardiomyopathy
- Major surgery within 2 weeks prior to treatment
- Medical or psychiatric conditions interfering with study participation or safety
- History of non-compliance with medical treatments
- Caregivers not comfortable with monitoring requirements or unable to complete follow-up assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Step-up dosing schedule as per product monograph
Participants receive step-up dosing of teclistamab in the outpatient setting, with some cohorts receiving prophylactic tocilizumab prior to the first dose.
Multiple outpatient visits during step-up dosing
Duration - Up to 1 year
Participants are monitored for hospital encounters, hospitalizations, and treatment-related toxicities for up to one year after treatment.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
C
Christine Chen, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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