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

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.

Study Overview

• Status: Recruiting
• Conditions: Myeloma; Myeloma Multiple
• Intervention / Treatment: Drug: Bortezomib Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amy Abel; Email: Amy.Abel@ahs.ca
• Study Contact Backup: Name: Jason Tay, MD; Phone Number: 403-944-3265; Email: Jason.Tay@ahs.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Recruiting
      • Tom Baker Cancer Centre
      • Contact: Amy Abel; Email: Amy.Abel@ahs.ca
      • Contact: Jason Tay, MD; Phone Number: 403-944-3265; Email: Jason.Tay@ahs.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Self Injection of Bortezomib; Subcutaneous self administration of bortezomib	Drug: Bortezomib Injection; Subcutaneous injection; Other Names: Velcade

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Collaborators: Tom Baker Cancer Centre
• Investigators: Principal Investigator: Jason Tay, MD, Tom Baker Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Bortezomib
• Other Study ID Numbers: EASE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No