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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    AHS Cancer Control Alberta
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Updated on 16 February 2024
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cancer
multiple myeloma
bortezomib

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.

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.

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age 18years - 100years
Treatment Bortezomib Injection
Clinical Study IdentifierNCT04268199
SponsorAHS Cancer Control Alberta
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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