Full Title:

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

Myeloma stage or condition:

Myeloma Myeloma Multiple

Study phase:

Phase 2

Summary/Purpose:

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.

Treatments:

Drug : Bortezomib Injection

Subcutaneous injection

Study Arms:

Other : Self Injection of Bortezomib
Subcutaneous self administration of bortezomib

Study Type:

Interventional

Study Design:

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Recruitment status:

Recruiting

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.

Locations / Centres:

Tom Baker Cancer Centre, Calgary, Alberta – Recruiting

Contacts:

Name: Jason Tay, MD
Phone: 403-944-3265
Email: [email protected]

Publications:

???

First posted:

2020-02-13

Actual start date:

May 29, 2020

Last updated:

2023-10-12

Estimated enrollment:

100

Estimated completion date:

2026-05-01

Estimated primary completion date:

2024-05-01

Condition:

Myeloma

Myeloma Multiple

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

No

Listed location countries:

Canada

NCT number:

NCT04268199

Other study ID numbers:

EASE

Has Data monitoring committee:

Yes

U.S. FDA-regulated product:

No

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

collaborator
Tom Baker Cancer Centre
Other

lead_sponsor
AHS Cancer Control Alberta
Other

Collaborators:

???

Investigators:

Jason Tay, MD Tom Baker Cancer Centre

Protocol Registration and Results System:

???

Verification date:

2023-10-01