Clinical trial NCT04268199: A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
Official title: A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myeloma
Myeloma Multiple
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Arthur J.E. Child Comprehensive Cancer Centre
First posted: 2020-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients able to self-administer
timeFrame: 2 years from study start
measure: Myeloma response outcomes
timeFrame: 2 years from study start
measure: Adverse events great than grade 3
timeFrame: 2 years from study start
measure: Number of patients with missed doses
timeFrame: 2 years from study start
measure: Patient Satisfaction and Quality of Life Survey 1
timeFrame: 2 years from study start
measure: Patient Satisfaction and Quality of Life Survey 2
timeFrame: 2 years from study start
measure: Patient Satisfaction and Quality of Life Survey 3
timeFrame: 2 years from study start
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Arthur J.E. Child Comprehensive Cancer Centre
name: Jason Tay, MD
role: PRINCIPAL_INVESTIGATOR
References: