MyelomaPhase 2EASENCT04268199
A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
A Phase 2 study testing Bortezomib Injection in people with Myeloma and Myeloma Multiple, run by AHS Cancer Control Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Myeloma Multiple
- What is being tested?
- Bortezomib Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesCanada
- Study dates
- 29 May 2020to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
About this study
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.
Read the 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.
- Conditions
- Myeloma, Myeloma Multiple
- Being tested
- Bortezomib Injection
- Medical subject headings
- Neoplasms, Plasma Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib InjectionDrug
Also called Velcade
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Self Injection of Bortezomib | Other | Subcutaneous self administration of bortezomib Receives: Drug: Bortezomib Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients able to self-administer
Number of eligible patients availing of self-administration
Measured: 2 years from study start
Myeloma response outcomes
Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented.
Measured: 2 years from study start
Adverse events great than grade 3
Adverse event documentation as per CTCAE version 5.0 scales of greater than grade 3
Measured: 2 years from study start
Number of patients with missed doses
Proportion of missed doses
Measured: 2 years from study start
Patient Satisfaction and Quality of Life Survey 1
Patient Satisfaction Surveys - FACIT-TS-PS (Functional Assessment of Chronic Illness Therapy)
Measured: 2 years from study start
Patient Satisfaction and Quality of Life Survey 2
Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer)
Measured: 2 years from study start
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)
Measured: 2 years from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start29 May 2020
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Why it stopped: Operational limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Tay, MD, Principal investigator, Arthur J.E. Child Comprehensive Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268199
- Sponsor's protocol ID
- EASE
- Acronym
- EASE
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2020
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
- ClinicalTrials.gov ID
- NCT04268199
- Acronym / sponsor ID
- EASE / EASE
- Conditions
- Myeloma, Myeloma Multiple
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Operational limitations
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self Injection of Bortezomib | Other | Drug: Bortezomib InjectionSubcutaneous self administration of bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib InjectionAlso: VelcadeSubcutaneous injection | Drug | Self Injection of Bortezomib |
Primary outcome
Number of patients able to self-administer
Time frame: 2 years from study start
Number of eligible patients availing of self-administration
Myeloma response outcomes
Time frame: 2 years from study start
Myeloma outcomes as per International Myeloma Foundation Response (IMWG) Criteria. For the purposes of this trial, best response will be documented.
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
Number of patients with missed doses
Time frame: 2 years from study start
Proportion of missed doses
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)
Patient Satisfaction and Quality of Life Survey 2
Time frame: 2 years from study start
Patient Satisfaction Surveys - CQOLC (Caregiver Quality of Life - Cancer)
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)
Results and safety
The study was stopped early (reason given: Operational limitations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Myeloma
RecruitingPhase 1
FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma
Relapse Multiple Myeloma, Refractory Multiple Myeloma
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
RecruitingPhase 3
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
High Risk Smoldering Multiple Myeloma (HR-SMM)
RecruitingPhase 2
Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis
Multiple Myeloma, Refractory to Standard Treatment, Multiple Myeloma, Relapsed
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Tay, MD principal investigator
Arthur J.E. Child Comprehensive Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib Injection in people with Myeloma and Myeloma Multiple, run by AHS Cancer Control Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Operational limitations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients able to self-administer (time frame: 2 years from study start). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.