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NCT Number: NCT04268199

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

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.

Recruiting

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Key information

Conditions

Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Myeloma Multiple Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bortezomib Injection

Drug

Subcutaneous injection

Other names: Velcade

Primary outcomes

  1. Number of patients able to self-administer

    Time frame: 2 years from study start

    Number of eligible patients availing of self-administration

  2. Myeloma response outcomes

    Time frame: 2 years from study start

    Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented.

  3. Adverse events great than grade 3

    Time frame: 2 years from study start

    Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3

  4. Number of patients with missed doses

    Time frame: 2 years from study start

    Proportion of missed doses

  5. Patient Satisfaction and Quality of Life Survey 1

    Time frame: 2 years from study start

    Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy)

  6. Patient Satisfaction and Quality of Life Survey 2

    Time frame: 2 years from study start

    Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer)

  7. Patient Satisfaction and Quality of Life Survey 3

    Time frame: 2 years from study start

    Patient Satisfaction Surveys - EORTC QLQ-MY20 (European Organization of Research and Treatment of Cancer - Quality of Life)

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Abel

CONTACT

[email protected]

Jason Tay, MD

CONTACT

[email protected]

587-231-5437

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Registry information

Acronym: EASE

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2020
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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