Les informations présentées dans l’Outil de recherche personnalisé d’essais cliniques de Myélome Canada sont issues de la base de données des essais cliniques internationaux du site
ClinicalTrials.gov,
répertoriées par la U.S. National Library of Medicine. Bien que le menu soit en français, les détails des études ne sont offerts qu’en anglais.
A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment (EASE)
*Les informations de l'essai contenues sur cette page ont été récupérées du site ClinicalTrials.gov. Cliquez ici pour voir cet essai sur ClinicalTrials.gov.
- Titre complet:
- A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
- Stade ou Condition:
- Myeloma Myeloma Multiple
- Phase d'étude:
- Phase 2
- Résumé:
- 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.
- Description détaillée:
- 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.
- Traitements:
- Drug : Bortezomib Injection
Subcutaneous injection
- Groupes d'étude:
- Other : Self Injection of Bortezomib
Subcutaneous self administration of bortezomib
- Type d'étude:
- Interventional
- Protocole de l'étude:
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Statut du recrutement:
- En cours
- Critères d'admissibilités:
-
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.
- 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.
- Lieux / Centres:
-
Tom Baker Cancer Centre, Calgary, Alberta – En cours
- Contacts:
- Name: Jason Tay, MD
Phone: 403-944-3265
Email: [email protected]
- Publications:
- ???
- Date d’affichage:
- 2020-02-13
- Date de début:
- May 29, 2020
- Dernière mise à jour:
- 2023-10-12
- Nombre d'inscriptions anticipées:
- 100
- Date de fin prévue:
- 2026-05-01
- Date de fin prévue de l'étude primaire:
- 2024-05-01
- Condition:
- Myeloma
- Myeloma Multiple
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Canada
- Numéro d’identification:
- NCT04268199
- Autres numéros d'identification de l'étude:
- EASE
- Comité de suivi des données:
- Yes
- Produit réglementé par la FDA (É-U):
- No
- IPD Sharing Statement :
- ???
- Responsables de l’étude:
-
Sponsor
- Commanditaires de l’étude:
- collaborator
Tom Baker Cancer Centre
Other - lead_sponsor
AHS Cancer Control Alberta
Other
- Collaborators:
- ???
- Chercheurs:
- Jason Tay, MD Tom Baker Cancer Centre
- Protocol Registration and Results System:
- ???
- Date de vérification:
- 2023-10-01