Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-dexamethasone (Vel/Dex) Followed by HDT With ASCT
HDT-ASCT is so far considered the standard of care for younger patients with multiple
myeloma (MM). Current evidence indicates that quality of response is an important prognostic
factor for long-term survival in MM. There are only very few data on molecular remissions
(MolR) determined by the most sensitive technique, allele-specific-oligonucleotide -
real-time quantitative - polymerase chain reaction (ASO-RQ-PCR) in MM, and there are no data
available on molecular responses after bortezomib-based induction therapy followed by
HDT-ASCT. The main aim of this study is to determine molecular response rate after ASCT
following bortezomib-based induction treatment compared to a historical control group with
conventional VAD induction treatment. A sensitivity of ASO-RQ-PCR technique will be compared
to immunofixation and with immunophenotyping by flow cytometry.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR
Before ASCT and 3-4 months after ASCT and then with 3-4 months interval
No
Raija H Silvennoinen, MD
Principal Investigator
Tampere University Hospital, Kuopio University Hospital
Finland: Finnish Medicines Agency
R08096M
NCT00861250
March 2009
December 2014
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