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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04268199
Other study ID # EASE
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 29, 2020
Est. completion date May 2026

Study information

Verified date October 2023
Source AHS Cancer Control Alberta
Contact Jason Tay, MD
Phone 403-944-3265
Email Jason.Tay@ahs.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2026
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Bortezomib Injection
Subcutaneous injection

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta

Sponsors (2)

Lead Sponsor Collaborator
AHS Cancer Control Alberta Tom Baker Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients able to self-administer Number of eligible patients availing of self-administration 2 years from study start
Primary Myeloma response outcomes Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria 2 years from study start
Primary 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
Primary Number of patients with missed doses Proportion of missed doses 2 years from study start
Primary 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
Primary Patient Satisfaction and Quality of Life Survey 2 Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer) 2 years from study start
Primary 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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