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

Primary Purpose

Myeloma, Myeloma Multiple

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Bortezomib Injection

About this trial

This is an interventional treatment trial for Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Tom Baker Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Self Injection of Bortezomib

Arm Description

Subcutaneous self administration of bortezomib

Outcomes

Primary Outcome Measures

Number of patients able to self-administer

Number of eligible patients availing of self-administration

Myeloma response outcomes

Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria

Adverse events great than grade 3

Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3

Number of patients with missed doses

Proportion of missed doses

Patient Satisfaction and Quality of Life Survey 1

Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy)

Patient Satisfaction and Quality of Life Survey 2

Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer)

Patient Satisfaction and Quality of Life Survey 3

Patient Satisfaction Surveys - EORTC QLQ-MY20 (European Organization of Research and Treatment of Cancer - Quality of Life)

Secondary Outcome Measures

Full Information

NCT ID

NCT04268199

First Posted

February 10, 2020

Last Updated

October 12, 2023

Sponsor

AHS Cancer Control Alberta

Collaborators

Tom Baker Cancer Centre

1. Study Identification

Unique Protocol Identification Number

NCT04268199

Brief Title

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

Acronym

EASE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 29, 2020 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

Tom Baker Cancer Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloma, Myeloma Multiple

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Self Injection of Bortezomib

Arm Type

Other

Arm Description

Subcutaneous self administration of bortezomib

Intervention Type

Drug

Intervention Name(s)

Bortezomib Injection

Other Intervention Name(s)

Velcade

Intervention Description

Subcutaneous injection

Primary Outcome Measure Information:

Title

Number of patients able to self-administer

Description

Number of eligible patients availing of self-administration

Time Frame

2 years from study start

Title

Myeloma response outcomes

Description

Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria

Time Frame

2 years from study start

Title

Adverse events great than grade 3

Description

Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3

Time Frame

2 years from study start

Title

Number of patients with missed doses

Description

Proportion of missed doses

Time Frame

2 years from study start

Title

Patient Satisfaction and Quality of Life Survey 1

Description

Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy)

Time Frame

2 years from study start

Title

Patient Satisfaction and Quality of Life Survey 2

Description

Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer)

Time Frame

2 years from study start

Title

Patient Satisfaction and Quality of Life Survey 3

Description

Patient Satisfaction Surveys - EORTC QLQ-MY20 (European Organization of Research and Treatment of Cancer - Quality of Life)

Time Frame

2 years from study start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jason Tay, MD

Phone

403-944-3265

Jason.Tay@ahs.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Abel

Amy.Abel@ahs.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Tay, MD

Organizational Affiliation

Tom Baker Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jason Tay, MD

Phone

403-944-3265

Jason.Tay@ahs.ca

First Name & Middle Initial & Last Name & Degree

Amy Abel

Amy.Abel@ahs.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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