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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-29

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myeloma Myeloma Multiple

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self Injection of Bortezomib

Subcutaneous self administration of bortezomib

Group Type OTHER

Bortezomib Injection

Intervention Type DRUG

Subcutaneous injection

Interventions

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Bortezomib Injection

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Velcade

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No