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| ID | Type | Description | Link |
|---|---|---|---|
| CAPCR 23-5935 | Other Identifier | University Health Network | |
| 64007957MMY4009 | Other Identifier | Janssen Inc. |
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| Name | Class |
|---|---|
| Janssen Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Give teclistamab step-up dosing at Princess Margaret Cancer Centre as per product monograph. |
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| 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. |
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| 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. |
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| Caregiver Cohort | No Intervention | Caregivers of participants in Cohorts 1, 2, and 3 will complete various questionnaires to assess impact. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Multiple Myeloma Patients to Receive Outpatient Teclistamab (Part 1):
Inclusion Criteria:
Eligible for teclistamab treatment as per Health Canada approved indication:
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:
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.
A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study, and thereafter to continue with product monograph guidelines. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.
A male participant must agree not to donate sperm for the purpose of reproduction during the study, and thereafter to follow product monograph guidelines with ongoing teclistamab off-study.
Exclusion Criteria:
Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
Prior or concurrent exposure to any of the following:
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:
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:
Major surgery within 2 weeks prior to the start of administration of study treatment (kyphoplasty or vertebroplasty are not considered major surgery).
Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:
Caregivers of multiple myeloma subjects treated with outpatient-based teclistamab (Part 2):
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Chen, Dr. | Contact | 416-946-2827 | Christine.Chen@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Christine Chen, Dr. | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| 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. |
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| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |