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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04268199
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AHS Cancer Control Alberta
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jason Tay, MD
Principal Investigator Affiliation Tom Baker Cancer Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myeloma, Myeloma Multiple
Additional Details

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.

Arms & Interventions

Arms

Other: Self Injection of Bortezomib

Subcutaneous self administration of bortezomib

Interventions

Drug: - Bortezomib Injection

Subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Status

Recruiting

Address

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2

Site Contact

Jason Tay, MD

Jason.Tay@ahs.ca

403-944-3265