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

Last updated: March 10, 2025
Sponsor: AHS Cancer Control Alberta
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Cancer/tumors

Blood Cancer

Treatment

Bortezomib Injection

Clinical Study ID

NCT04268199
EASE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withteaching,

  • Previously received more than 4 injections of bortezomib within the hospital and/orcancer centre environment,

  • Signed informed consent.

Exclusion

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Bortezomib Injection
Phase: 2
Study Start date:
May 29, 2020
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

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