Multiple Myeloma Clinical Trial
Official title:
The Molecular Characterization of Multiple Myeloma at Relapse
Observational study investigating prognostic factors in newly diagnosed and relapsed multiple myeloma patients by use of clinical data, biochemical markers (blood samples), cytogenetic markers and gene expression profiling (myeloma cells from fresh bone marrow samples). Enabling future genetic studies by establishing a biobank of bone marrow and peripheral blood samples.
Multiple myeloma (MM) is an incurable cancer. The disease can often be brought to a halt
with chemotherapy which in younger patients is accompanied by stem cell transplantation. But
the disease relapses almost invariably. Cytogenetic changes in the myeloma cells can serve
as prognostic markers. Accordingly, 25% of the patients show changes associated with a
prognosis so poor that they should probably receive experimental treatment right from the
start. Nevertheless, a part of these patients survive much longer than expected. Thus, the
prognosis must depend on additional genetic events.
The aim of this project is to widen the investigators knowledge of the nature, chronology
and prognostic value of the genetic events in MM in order to improve the risk stratification
of the patients and hence the choice of treatment. Using cytogenetics (interphase FISH) and
molecular biological analyses (SNP, GEP, miRNA) the investigators will study the changes in
the myeloma cells. The investigators will search for genetic and clinical differences
between patients within the same cytogenetic group and between patients at diagnosis and at
relapse. The study population will consist of 100 newly diagnosed patients and 100 relapse
patients included prospectively over a 2-year period in a cooperation between the four
departments of hematology in Zealand, Denmark.
Hypotheses:
1. Early relapse depends on a) molecular defects in the myeloma cells detectable with
FISH, GEP, SNP and/or miRNA analyses, and b) the acquisition of new mutations resulting
in chemotherapy resistance and increased prolific capacity.
2. The progressive reduction of event free survival seen with every relapse until the
disease turns refractory can be explained by selection of critical mutations.
3. The cytogenetic changes associated with poor prognosis represent a heterogenous group
of patients in whom the responsible genetic events remain unknown.
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Observational Model: Cohort, Time Perspective: Prospective
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