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

Phase 2RecruitingNCT04268199

AHS Cancer Control Alberta100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Myeloma Myeloma Multiple

Interventions

Bortezomib InjectionDRUG

Subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, Canada

RECRUITING