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This study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. All tests and assessments are based on standard of care procedures.
Chemotherapy for malignancies is predominantly prescribed and delivered in a tertiary hospital and/or cancer centre setting. However, with modern chemotherapy, with a reduced side effect profile, this paradigm should be challenged. Indeed, the use of methotrexate and other biologics (a form of chemotherapy) in the Rheumatologic setting is commonly delivered effectively and safely in the community.
Taken together, a hospital-based model of chemotherapy delivery may not be warranted in all circumstances. Moreover, the use of this current model invariably discounts the time commitments, needs of patients and caregivers, as well as while not addressing the emerging concerns regarding system capacity, efficiency and effectiveness of safe chemotherapy delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self Injection of Bortezomib | Other | Subcutaneous self administration of bortezomib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib Injection | Drug | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients able to self-administer | Number of eligible patients availing of self-administration | 2 years from study start |
| Myeloma response outcomes | Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented. | 2 years from study start |
| Adverse events great than grade 3 | Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3 | 2 years from study start |
| Number of patients with missed doses | Proportion of missed doses | 2 years from study start |
| Patient Satisfaction and Quality of Life Survey 1 | Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy) | 2 years from study start |
| Patient Satisfaction and Quality of Life Survey 2 | Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer) | 2 years from study start |
| Patient Satisfaction and Quality of Life Survey 3 | Patient Satisfaction Surveys - EORTC QLQ-MY20 (European Organization of Research and Treatment of Cancer - Quality of Life) | 2 years from study start |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Tay, MD | Contact | 587-231-5437 | Jason.Tay@ahs.ca | |
| Amy Abel | Contact | Amy.Abel@ahs.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jason Tay, MD | Arthur J.E. Child Comprehensive Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur J.E. Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
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| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
|
| 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 |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |