Back to resultsBortezomib Consolidation Trial (BCT)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring MM, HDT, ASCT, consolidation, bortezomib
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University College London
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bortezomib consolidation
Arm Description
Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)
Outcomes
Primary Outcome Measures
Change in Disease response
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
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
Secondary Outcome Measures
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
assess the effect of bortezomib consolidation on Minimal Residue Disease status
determine progression free survival
evaluate the quality of life for patients receiving bortezomib consolidation
Full Information
NCT ID
NCT01517724
First Posted
December 20, 2011
Last Updated
April 16, 2019
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT01517724
Brief Title
Bortezomib Consolidation Trial
Acronym
BCT
Official Title
Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
MM, HDT, ASCT, consolidation, bortezomib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib consolidation
Arm Type
Experimental
Arm Description
Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
Primary Outcome Measure Information:
Title
Change in Disease response
Description
Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.
Time Frame
At 6 and 12 months after ASCT consolidated by bortezomib therapy
Title
Number of patients with adverse events
Description
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
Time Frame
Up to 8 months after treatment start
Secondary Outcome Measure Information:
Title
assess effect of bortezomib consolidation on bone health
Description
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
Time Frame
At 1, 2, 3 and 9 months after start of treatment
Title
assess the effect of bortezomib consolidation on Minimal Residue Disease status
Time Frame
At 6 and 12 months post ASCT
Title
determine progression free survival
Time Frame
At 2 years post ASCT
Title
evaluate the quality of life for patients receiving bortezomib consolidation
Time Frame
Up to 8 months after treatment start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwee Yong
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London
City
London
Country
United Kingdom
12. IPD Sharing Statement
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Bortezomib Consolidation Trial
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