Recruiting
Phase 2

Chemotherapy

Sponsor:

AHS Cancer Control Alberta

Code:

NCT04268199

Conditions

Myeloma

Myeloma Multiple

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bortezomib Injection

Study Details

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

Study ID

NCT04268199

Start date

May 29, 2020

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Self Injection of Bortezomib

Subcutaneous self administration of bortezomib

Interventions

Bortezomib Injection

Subcutaneous injection

Primary outcome measure

  • Number of patients able to self-administer [ Time Frame: 2 years from study start ]
  • Myeloma response outcomes [ Time Frame: 2 years from study start ]
  • Adverse events great than grade 3 [ Time Frame: 2 years from study start ]
  • Number of patients with missed doses [ Time Frame: 2 years from study start ]
  • Patient Satisfaction and Quality of Life Survey 1 [ Time Frame: 2 years from study start ]
  • Patient Satisfaction and Quality of Life Survey 2 [ Time Frame: 2 years from study start ]
  • Patient Satisfaction and Quality of Life Survey 3 [ Time Frame: 2 years from study start ]

Central Contacts and Locations

Central contacts

Jason Tay, MD

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

Amy Abel

Amy.Abel@ahs.ca

Locations

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Jason Tay, MD

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

Amy Abel

Amy.Abel@ahs.ca

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Joanne Hewitt

joanne.hewitt@albertahealthservices.ca

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2025-12-15.