RecruitingPhase 2NCT04268199

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


Sponsor

AHS Cancer Control Alberta

Enrollment

100 participants

Start Date

May 29, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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.

Interventions

DRUGBortezomib Injection

Subcutaneous injection


Locations(2)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

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NCT04268199


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