Bortezomib Consolidation Trial

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bortezomib consolidation<br>Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks) | Drug: Bortezomib<br>* 1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles<br>* Other names: Velcade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disease response | Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT. | 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 | Up to 8 months after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At 1, 2, 3 and 9 months after start of treatment | 
| assess the effect of bortezomib consolidation on Minimal Residue Disease status |  | At 6 and 12 months post ASCT | 
| determine progression free survival |  | At 2 years post ASCT | 
| evaluate the quality of life for patients receiving bortezomib consolidation |  | Up to 8 months after treatment start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MM, HDT, ASCT, consolidation, bortezomib