Myeloma, Myeloma Multiple
Conditions
Brief summary
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
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.
Interventions
Subcutaneous injection
Sponsors
AHS Cancer Control Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients able to self-administer | 2 years from study start | Number of eligible patients availing of self-administration |
| Myeloma response outcomes | 2 years from study start | Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented. |
| Adverse events great than grade 3 | 2 years from study start | Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3 |
| Number of patients with missed doses | 2 years from study start | Proportion of missed doses |
| Patient Satisfaction and Quality of Life Survey 1 | 2 years from study start | Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy) |
| Patient Satisfaction and Quality of Life Survey 2 | 2 years from study start | Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer) |
| Patient Satisfaction and Quality of Life Survey 3 | 2 years from study start | Patient Satisfaction Surveys - EORTC QLQ-MY20 (European Organization of Research and Treatment of Cancer - Quality of Life) |
Countries
Canada
Contacts
Primary ContactJason Tay, MD
Backup ContactAmy Abel
Outcome results
None listed