Health TrialsbyHealthPanel

Plan Development for Giving Teclistamab in the Outpatient Setting

ConditionsMultiple MyelomaRelapsed CancerRefractory Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 4 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 2 interventions
Group D: Caregiver CohortNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Median of day hospital encounters or hospitalizations as assessed by using descriptive statistics.

Used to guide development of written processes and protocols for teclistamab outpatient management.

Time frame
1 year
2

Median incidence of toxicities that are related to underlying disease, disease-related or background regimen as assessed by CTCAE v5.0.

Used to guide development of written processes and protocols for teclistamab outpatient management.

Time frame
1 year

Secondary outcomes

1

Median for Caregiver Quality of Life Index-Care (CQOLC) scale. Minimum value is 0, maximum value is 140. Lower score means worse outcome.

Used to assess caregiver burden.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Janssen Inc.

Collaborator

Source ClinicalTrials.gov
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