Multiple MyelomaPhase 2BCTNCT01517724
Bortezomib Consolidation Trial
A Phase 2 study testing Bortezomib in people with Multiple Myeloma, run by University College, London at 1 site in United Kingdom.
Trial summary
The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to 24 Jan 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed
- Age 18 - 70 years
- Life expectancy > 6 months
- Written informed consent
- Creatinine < 400µmol/L
- Bilirubin < 3x upper limit of normal
- WHO performance status 0-2
- Contraceptive precautions where appropriate
Who cannot join
- Received bortezomib previously
- On, or planned for, steroid therapy
- Poor performance status (ECOG ≥ 3)
- Disease progression at any stage
- Past history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2
- Severe hepatic impairment, indicated by bilirubin ≥ 3x upper limit of normal, or AST > 2.5x upper limit of normal
Show all 16Show fewer
- Pregnant or lactating women
- Allergic reaction attributable to bortezomib or to compounds containing boron or mannitol
- Severe cardiovascular disease
- History of acute infiltrative pulmonary or pericardial disease
- History of hypotension or has decreased blood pressure
- Peripheral neuropathy ≥ grade 2, or neuropathic pain
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Received any drugs or agents that inhibit or induce CYP2C19 or CYP3A4 within 14 days before the first dose of bortezomib
- Need for therapy with concomitant CYP 3A4 or CYP2C19 inhibitors
- Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma
The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib
- Keywords
- MM, HDT, ASCT, consolidation, bortezomib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade
1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib consolidation | Experimental | Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks) Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease response
Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.
Measured: At 6 and 12 months after ASCT consolidated by bortezomib therapy
Number of patients with adverse events
The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT
Measured: Up to 8 months after treatment start
Secondary outcomes (4)
assess effect of bortezomib consolidation on bone health
Summary of changes from baseline, after cycle 1,2 and 3 of bortezomib treatment and at the end of treatment for markers of bone formation and resorption
Measured: At 1, 2, 3 and 9 months after start of treatment
assess the effect of bortezomib consolidation on Minimal Residue Disease status
Measured: At 6 and 12 months post ASCT
determine progression free survival
Measured: At 2 years post ASCT
evaluate the quality of life for patients receiving bortezomib consolidation
Measured: Up to 8 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startDec 2009
- Primary completionDec 2014
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwee Yong, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517724
- Sponsor's protocol ID
- UCL/08/0170
- Acronym
- BCT
- Status last verified
- Mar 2019
- First submitted
- 20 Dec 2011
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01517724
- Acronym / sponsor ID
- BCT / UCL/08/0170
- Conditions
- Multiple Myeloma
- Keywords
- MM, HDT, ASCT, consolidation, bortezomib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 25 Jan 2012 (estimated)
- 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.
The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib consolidation | Experimental | Drug: BortezomibBortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- MM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed
- Age 18 - 70 years
- Life expectancy > 6 months
- Written informed consent
- Creatinine < 400µmol/L
Key exclusion criteria (16 listed)
- Received bortezomib previously
- On, or planned for, steroid therapy
- Poor performance status (ECOG ≥ 3)
- Disease progression at any stage
- Past history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2
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 |
|---|---|---|
| BortezomibAlso: Velcade1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles | Drug | Bortezomib consolidation |
Primary outcome
Change in Disease response
Time frame: At 6 and 12 months after ASCT consolidated by bortezomib therapy
Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.
Number of patients with adverse events
Time frame: Up to 8 months after treatment start
The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT
4 secondary outcomes
assess effect of bortezomib consolidation on bone health
Time frame: At 1, 2, 3 and 9 months after start of treatment
assess the effect of bortezomib consolidation on Minimal Residue Disease status
Time frame: At 6 and 12 months post ASCT
determine progression free survival
Time frame: At 2 years post ASCT
evaluate the quality of life for patients receiving bortezomib consolidation
Time frame: Up to 8 months after treatment start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
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.
Kwee Yong principal investigator
University College, London
1 site 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 in people with Multiple Myeloma, run by University College, London at 1 site in United Kingdom.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Disease response (time frame: At 6 and 12 months after ASCT consolidated by bortezomib therapy). The study lists 2 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 17 Apr 2019.