Bortezomib Consolidation Trial

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Bortezomib

• Registration Number: NCT01517724
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-25
• Primary Completion: 2014-12
• Study Completion: 2019-01-24
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bortezomib consolidation	Bortezomib	Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)

Primary Outcome Measures

Name	Time	Method
Change in Disease response	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	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

Secondary Outcome Measures

Name	Time	Method
assess effect of bortezomib consolidation on bone health	At 1, 2, 3 and 9 months after start of treatment	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	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

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom