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

NCT04268199 | Recruiting Phase 2 DMC

• 1 other identifier: EASE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myeloma; Myeloma Multiple

Outcome Measures

Primary Outcomes (7)

• 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. For the purposes of this trial, best response will be documented.

  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

Study Arms (1)

Self Injection of Bortezomib

OTHER

Subcutaneous self administration of bortezomib

Drug: Bortezomib Injection

Interventions

Bortezomib Injection DRUG

Subcutaneous injection

Also known as: Velcade

Self Injection of Bortezomib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (2)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jason Tay, MD

  Arthur J.E. Child Comprehensive Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Tay, MD

CONTACT

587-231-5437; Jason.Tay@ahs.ca

Amy Abel

CONTACT

Amy.Abel@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: May 29, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)