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

Myeloma Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04268199
• Other study ID #: EASE
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

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