A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment

Conditions
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Myeloma, Myeloma Multiple

Intervention / Treatment
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* Drug: Bortezomib Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are aged 18 years old or older with a diagnosis of symptomatic myeloma, Stable clinical status as deemed by responsible investigator, Personally (or caregiver) willing and deemed capable to self-administer with teaching, Previously received more than 4 injections of bortezomib within the hospital and/or cancer centre environment, Signed informed consent. Exclusion Criteria: Currently participating in clinical trials that includes the use of bortezomib, History of allergic reactions to bortezomib, History of bleeding attributable to bortezomib, History of greater than or equal to grade 3 side effects attributable to bortezomib, Clinically deemed unlikely to be compliant with therapy by responsible investigator, Life expectancy anticipated to be less than 6 months, Deemed geographically inaccessible to receive care.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Self Injection of Bortezomib<br>Subcutaneous self administration of bortezomib | Drug: Bortezomib Injection<br>* Subcutaneous injection<br>* Other names: Velcade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 |