Plan Development for Giving Teclistamab in the Outpatient Setting

NCT06251076 | Recruiting Phase 4 DMC

• 3 other identifiers: Outpatient TECCAPCR 23-593564007957MMY4009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma; Relapsed Cancer; Refractory Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  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.

  1 year

Study Arms (4)

Cohort 1

EXPERIMENTAL

Give teclistamab step-up dosing at Princess Margaret Cancer Centre as per product monograph.

Drug: Teclistamab

Cohort 2

EXPERIMENTAL

Give teclistamab step-up dosing at Princess Margaret Cancer Centre with the addition of one dose of prophylactic tocilizumab prior to step-up dose 1.

Drug: Teclistamab; Drug: Tocilizumab

Cohort 3

EXPERIMENTAL

Give teclistamab step-up dosing at Southlake Regional Cancer Centre in the outpatient setting using the best method(s) as determined from Cohorts 1 and 2.

Drug: Teclistamab; Drug: Tocilizumab

Caregiver Cohort

NO INTERVENTION

Caregivers of participants in Cohorts 1, 2, and 3 will complete various questionnaires to assess impact.

Interventions

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.

Also known as: TECVAYLI

Cohort 1; Cohort 2; Cohort 3

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.

Also known as: ACTEMRA

Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for teclistamab treatment as per Health Canada approved indication:
• 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
• For Cohorts 1 and 2, participants must agree to receive treatment at Princess Margaret Cancer Centre. For Cohort 3, participants must agree to receive treatment at Stronach Regional Cancer Centre.
• Must sign the informed consent form (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease.
• Have one or more caregivers meeting study criteria.
• Have clinical laboratory values meeting study criteria.
• Rockwood Clinical Frailty Scale - threshold score ≤ 5
• A woman of childbearing potential must have a negative highly-sensitive serum pregnancy test at screening and must agree to:
• Practicing true abstinence; or
• Have a sole partner who is vasectomized; or
• Practicing ≥1 highly-effective, user-independent method of contraception.
• A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study. Upon study end, female participants must agree to continue with product monograph guidelines with ongoing teclistamab off-study.

You may not qualify if:

• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
• Prior or concurrent exposure to any of the following:
• 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
• High risk disease features including:
• Central nervous system (CNS) involvement with myeloma
• Extramedullary disease (≥1 soft tissue plasmacytoma not associated with bone)
• Circulating plasma cells (plasma cell leukemia)
• Rapidly progressive disease, as per investigator assessment
• Concurrent disorders, including:
• e. Light chain amyloidosis f. Second malignancy requiring active therapy, exceptions including prostate cancer receiving androgen deprivation therapy or adequately treated breast cancer carcinoma on anti-hormonal agents and considered to have a very low risk of recurrence g. Underlying neurologic dysfunction (history of seizure, Cerebrovascular Accident (CVA) or Transient ischemic attack (TIA), intracranial hemorrhage, dementia or other cognitive impairment) h. Hepatitis B infection (HBV-DNA positive). Patients with HepBsAg (Surface antigen of Hepatitis B virus) or HepBcAb (Hepatitis B viral protein) positive are allowed on study, only if on antiviral prophylaxis and HBV-DNA viral load is undetectable.
• i. Active infection requiring anti-infective therapy (prophylactic antibiotics are allowed). Cytomegalovirus (CMV) IgG (Immunoglobulin G) positivity allowed, but must be CMV PCR (Polymerase Chain Reaction) negative.
• j. Underlying coagulopathy that may increase the risk of bleeding in the setting of cytopenia.
• Presence of the following cardiac conditions:

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Janssen Inc.: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Recurrence; Neoplasms

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine Chen, Dr.

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Chen, Dr.

CONTACT

416-946-2827; Christine.Chen@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (1)