Plan Development for Giving Teclistamab in the Outpatient Setting
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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 criteria
Qualifiers
Age 18 and greater
Relapsed or refractory multiple myeloma
Received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
Demonstrated disease progression on the last therapy
Disqualifiers
Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
Teclistamab or any anti-BCMA therapy
Other myeloma therapy (standard of care or investigational) including corticosteroids, within 3 days of first step-up dose of teclistamab
Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
Trial design
Treatments tested in this trial
- Teclistamab
- Tocilizumab
Treatment groups
15 Participants
are divided into 4 treatment groupsSponsors and collaborators
University Health Network, Toronto
Lead sponsor
Janssen Inc.
Collaborator
Source ClinicalTrials.gov