Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05)
Rationale:
ASCT prolongs EFS and OS for myeloma patients < 65 years of age. During the period from ASCT
to progression most myeloma patients experience few symptoms and have a good quality of
life11. A further prolongation of EFS would be a big step forward in myeloma treatment.
Bortezomib is a new promising agent, which has shown clear anti-myeloma effect in heavily
pre-treated patients. After ASCT the tumour cell burden is low and it is the hypothesis of
this clinical trial that the unique mechanism of action of bortezomib may reduce the number
of tumour cells even further and by doing so prolong EFS.
Primary objective:
* Evaluate the effect on EFS (an event is defined as either progression or death of any
cause without preceding progression) of consolidation treatment with bortezomib after ASCT
compared to no consolidation
Secondary objectives:
- Overall survival from ASCT
- Overall survival from start of relapse treatment
- Time to need for relapse treatment
- Response rate in patients not in CR following ASCT
- Toxicity from consolidation treatment
- Quality of life
- Cost utility
- Planned subgroup analysis: comparison of primary and secondary endpoint in patients
receiving one vs. two high dose treatments
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation
1 year after randomization of the last patient
Yes
Ulf-Henrik Mellqvist, Dr., PhD
Principal Investigator
NMSG
Sweden: Medical Products Agency
NMSG 15/05
NCT00417911
December 2005
May 2010
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