Actively Recruiting
Plan Development for Giving Teclistamab in the Outpatient Setting
Led by University Health Network, Toronto · Updated on 2025-12-10
15
Participants Needed
1
Research Sites
97 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
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
Official 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 therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Demonstrated disease progression on the last therapy
- Willing to receive treatment at the designated cancer center based on cohort
- Signed informed consent form
- Have one or more caregivers meeting study criteria
- Clinical laboratory values meet study requirements
- Rockwood Clinical Frailty Scale score of 5 or less
- Women of childbearing potential have a negative serum pregnancy test and agree to use effective contraception or abstinence during the study
- Women agree not to donate eggs or freeze them for reproduction during the study
- Men agree to use condoms during sexual activity and not to 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 any anti-BCMA therapy
- Receiving other myeloma treatments including corticosteroids within 3 days before first dose
- Unresolved toxicities from previous cancer therapies above Grade 1 except alopecia or peripheral neuropathy
- High-risk disease features including CNS involvement, extramedullary disease, circulating plasma cells, or rapidly progressive disease
- Certain concurrent disorders including light chain amyloidosis, active second malignancies needing therapy (with exceptions), significant neurological dysfunction, or hepatitis B infection without antiviral prophylaxis
- Active infection requiring antibiotics (except prophylactic), coagulopathy increasing bleeding risk
- Specific cardiac conditions such as severe heart failure, recent heart attack, significant arrhythmia, or severe cardiomyopathy
- Major surgery within 2 weeks before treatment start
- Medical or psychiatric conditions that interfere with study participation or safety, including uncontrolled diabetes, active infections, autoimmune diseases (with exceptions), disabling psychiatric disorders, severe dementia, or other serious comorbidities
- History of non-compliance with medical treatments
- Caregivers unable to comfortably perform required monitoring and follow-up assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
C
Christine Chen, Dr.
CONTACT
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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