Multiple myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VELCADE
Product Name: Bortezomib (subcutaneous administration)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bortezomib (PS-341)
CAS Number: 179324697
Current
Sponsors
University College London
CR UK and UCL Cancer Trials Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the effect of bortezomib on osteoblast and osteoclast function in patients following HDT and ASCT. To determine the effect of bortezomib consolidation on MRD status at 6 and 12 months post ASCT. To determine the 2-year progression free survival (PFS) and median PFS after HDT and ASCT followed by consolidation with bortezomib. To evaluate the quality of life of patients receiving bortezomib consolidation after ASCT. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the disease response at 6 and 12 months following autologous stem cell transplantation (ASCT) consolidated by bortezomib therapy. This tests the hypothesis that the intervention improves disease response following ASCT • To evaluate the safety, toxicity and tolerability of bortezomib as consolidation therapy following high dose melphalan (HDT) with Melphalan (200mg/m2) and ASCT.;Secondary Objective: • To evaluate the quality of life of patients receiving bortezomib consolidation after ASCT. • To determine the 2-year progression free survival (PFS) and median PFS after HDT and ASCT followed by consolidation with bortezomib. • To determine the effect of bortezomib on osteoblast and osteoclast function in patients following HDT and ASCT. • To assess MRD status at 6 and 12 months after ASCT consolidated by bortezomib.;Primary end point(s): Disease response at 6 and 12 months following autologous stem cell transplantation (ASCT) consolidated by bortezomib therapy. Disease responses are as defined in the International Uniform response criteria, ref. Durie et al, Leukaemia, 2007 Safety and tolerability of bortezomib consolidation therapy starting at 3 months post high dose melphalan and autologous stem cell. | — |
Countries
United Kingdom
Outcome results
None listed