A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
Bortezomib Injection
DrugSubcutaneous injection
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Self Injection of BortezomibOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients able to self-administer
Number of eligible patients availing of self-administration
Time frame
2 years from study start2
Myeloma response outcomes
Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented.
Time frame
2 years from study start3
Adverse events great than grade 3
Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3
Time frame
2 years from study start4
Number of patients with missed doses
Proportion of missed doses
Time frame
2 years from study startSponsors and contacts
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Source ClinicalTrials.gov