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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268199
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : May 5, 2022
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment Phase
Myeloma Myeloma Multiple Drug: Bortezomib Injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

Arm Intervention/treatment
Self Injection of Bortezomib
Subcutaneous self administration of bortezomib
Drug: Bortezomib Injection
Subcutaneous injection
Other Name: Velcade




Primary Outcome Measures :
  1. Number of patients able to self-administer [ Time Frame: 2 years from study start ]
    Number of eligible patients availing of self-administration

  2. Myeloma response outcomes [ Time Frame: 2 years from study start ]
    Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria

  3. Adverse events great than grade 3 [ Time Frame: 2 years from study start ]
    Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3

  4. Number of patients with missed doses [ Time Frame: 2 years from study start ]
    Proportion of missed doses

  5. Patient Satisfaction and Quality of Life Survey 1 [ Time Frame: 2 years from study start ]
    Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy)

  6. Patient Satisfaction and Quality of Life Survey 2 [ Time Frame: 2 years from study start ]
    Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer)

  7. Patient Satisfaction and Quality of Life Survey 3 [ Time Frame: 2 years from study start ]
    Patient Satisfaction Surveys - EORTC QLQ-MY20 (European Organization of Research and Treatment of Cancer - Quality of Life)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268199


Contacts
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Contact: Jason Tay, MD 403-944-3265 Jason.Tay@ahs.ca
Contact: Amy Abel Amy.Abel@ahs.ca

Locations
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Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Jason Tay, MD    403-944-3265    Jason.Tay@ahs.ca   
Contact: Amy Abel       Amy.Abel@ahs.ca   
Sponsors and Collaborators
AHS Cancer Control Alberta
Tom Baker Cancer Centre
Investigators
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Principal Investigator: Jason Tay, MD Tom Baker Cancer Centre
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT04268199    
Other Study ID Numbers: EASE
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents