1. BCT
Bortezomib Consolidation Trial
Phase II study of bortezomib consolidation after high dose therapy (HDT) and autologous stem cell transplantation (ASCT) for multiple myeloma (MM)
PRIMARY OBJECTIVES
A phase II, non-randomised, single arm, multi-site, non-commercial trial aiming to determine the effect of bortezomib consolidation on the outcome of ASCT in patients with myeloma, and to assess the effect of bortezomib consolidation on bone health, as measured by serum markers of osteoblast and osteoclast function.
Disease response at 6 and 12 months following ASCT consolidated by bortezomib therapy.
Safety, toxicity and tolerability of bortezomib as consolidation therapy following HDT with Melphalan (200mg/m²) and ASCT.
OFF TRIAL
Control Group
Eligible patients
who declined treatment
Treatment Group
CR/VGPR/MR/SD
Follow every 4 months until disease progression or death
Continue with bortezomib
to 8 cycles if tolerated
Assess Response
at 12 months post ASCT
Bortezomib
3 cycles
at 6 months post ASCT
Progression
High Dose Melphalan/ASCT
3 months post ASCT
NOT progressed
Informed consent
Screening/Registratin
Serum sample for bone marker assessment
3 & 6 months post ASCT
PATIENT ELIGIBILITY
SECONDARY OBJECTIVES
Diagnosed with symptomatic (including non- secretory) Multiple Myeloma
Received high dose Melphalan with ASCT 3-4 months previously and have at least stable disease
Age years
Life expectancy >6 months
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
Have NOT received bortezomib prior to commencing this trial
Bilirubin ≤3x ULN, or AST ≤ 2.5x ULN
Do NOT have persisting neurological deficit grade 2 or greater
Have NOT received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
Please see protocol for further details
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 (assessed by multi-parameter flow cytometry on bone marrow)
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
SITES OPEN TO RECRUITMENT
University College London Hospital (Prof K Yong)
Royal Free Hospital (Dr D Hugh)
Dorset County Hospital (Dr A Moosa)
SITES IN SET UP
SAMPLE SIZE
45 patients treatment group
20 patients control group
Royal Bournemouth Hospital (Dr H McCarthy)
Queen Elizabeth Hospital, Birmingham (Dr M Cook)
SITE ELIGIBILITY
Site registration form
R&D approval
Signed Clinical Trial Site Agreement
Delegation log
PI CV/GCP
BCT - Haematology Trials Group Cancer Research UK & UCL Cancer Trials Centre 90 Tottenham Court Road, London, W1T 4TJ
CHIEF INVESTIGATOR: Prof Kwee Yong
University College London Hospital