Trial Details

Trial status:

Archived

Recruitment start date:

29/11/2009

Funder:

Sponsor:

UCL

Chief Investigator:

Prof Kwee Yong

Recruitment target:

EudraCT number:

2008-006751-48

Contact details:

ctc.bct@ucl.ac.uk

Note: For enquiries only. DO NOT use for clinical referrals.

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.

Contact the trial team

View trial summary

View trial documents

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

CTC staff

University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000