PHASE II STUDY OF BORTEZOMIB CONSOLIDATION AFTER HIGH DOSE THERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION FOR MULTIPLE MYELOMA - Bortezomib Consolidation Trial

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-006751-48-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-22
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diagnosed with symptomatic (including non-secretory) multiple myeloma • Patient will have received high dose Melphalan with ASCT 3-4 months previously and have at least stable disease (i.e. do not have progressive disease) • Age 18 - 70 years • Life expectancy >6 months • Patients must be able to give written informed consent • Creatinine <400µmol/L • Bilirubin <3x upper limit of normal • ECOG performance status 0-2 • Agreed compliance with recommended contraceptive precautions where appropriate
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Received bortezomib at any point prior to commencing this trial Received bisphosphonate therapy since ASCT • On, or planned for systemic steroid therapy (e.g. Dexamethasone or prednisolone). Local steroid therapy (e.g. inhaled corticosteroids for asthma or topical corticosteroids for eczema) are allowed • Disease progression at any stage during/after high dose therapy • Past history of polio, cord compression or other significant neurological problems resulting in persisting neurological deficit Grade 2 or greater Severe hepatic impairment, indicated by bilirubin =3x upper limit of normal, or AST/ALT >2.5x upper limit of normal • Pregnant or lactating women. Women of childbearing potential* must have a negative blood pregnancy test within 24 hours of starting study drug and must agree to appropriate contraceptive use. • Patient has a history of allergic reaction attributable to compounds containing boron or mannitol • Severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Appendix 3, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis • History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] =100 mmHg and/or sitting diastolic blood pressure [DBP] =60 mmHg) • Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 • Serious medical or psychiatric illness likely to interfere with participation in this clinical study • Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified