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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
29/11/2009
Funder:
Sponsor:
UCL
Chief Investigator:
Prof Kwee Yong
Recruitment target:
65
EudraCT number:
2008-006751-48
Contact details:
ctc.bct@ucl.ac.uk
Lay summary:
BCT
PHASE II STUDY OF BORTEZOMIB CONSOLIDATION AFTER HIGH DOSE THERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION FOR MULTIPLE MYELOMA
Description
Design: BCT is a non-randomised, single arm, multicentre, phase II trial of bortezomib consolidation after high dose therapy (HDT) and autologous stem cell transplantation (ASCT) for patients with multiple myeloma. 
Treatment:
Patients will be assessed after 3 months post high dose melphalan with ASCT for trial eligibility. Trial patients will receive bortezomib consolidation in 4-weekly cycles starting at 3 months post-ASCT. Treatment will be with bortezomib 1.3mg/m2 by subcutaneous injection on days 1, 8, 15 and 22 of each 28-day cycle. 

After 3 cycles, at approximately 6 months post ASCT, patients will undergo re-staging of their disease. 
Patients with progressive disease will stop trial treatment. All other patients will continue treatment up to a maximum of 8 cycles, as tolerated. 

Key inclusion/exclusion criteria:

Inclusion Criteria
  • Multiple myeloma patients who have received high dose melphalan with ASCT 3-4 months prior to registration and not have progressed
  • Age 18-70 years
  • Life expectancy >6 months
  • Creatinine
  • Bilirubin
  • WHO 0-2

Exclusion Criteria
  • Previous treatment with bortezomib 
  • Bisphosphonate therapy since ASCT
  • On or planned for systemic steroid therapy (e.g. dexamethasone or prednisolone)
  • Disease progression at any stage during/after high dose therapy
  • Persisting neurological deficit ≥ grade 2
  • Severe hepatic impairment
  • Severe cardiovascular disease
  • History of acute infiltrative pulmonary or pericardial disease
  • Hypotension or decreased blood pressure
  • Peripheral neuropathy ≥ grade 2; neuropathic pain
  • Allergic reaction attributable to bortezomib or to compounds containing boron or mannitol
  • Pregnant or lactating women
Duration of recruitment: 3 years
Aim
To determine the effect of bortezomib consolidation on the outcome of ASCT in patients with multiple myeloma and to assess the effect of bortezomib consolidation on bone health, based on serum markers of osteoblast and osteoclast function.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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