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

AHS Cancer Control Alberta

Status and phase: Enrolling; Phase 2

Conditions: Myeloma Multiple; Myeloma

Treatments: Drug: Bortezomib Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04268199

EASE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Self Injection of Bortezomib

Other group

Description:

Subcutaneous self administration of bortezomib

Treatment:

Drug: Bortezomib Injection