Clinical trial · Interventional
A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
NCT04268199CI-TRIAL-00098967EASErecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Myeloma Multiple | Plasma Cell Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib Injection | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Self Injection of Bortezomib
- description
- Subcutaneous self administration of bortezomib
- interventionNames
- Drug: Bortezomib Injection
Primary outcomes (7)
- measure
- Number of patients able to self-administer
- timeFrame
- 2 years from study start
- description
- Number of eligible patients availing of self-administration
- measure
- Myeloma response outcomes
- timeFrame
- 2 years from study start
- description
- Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.