Multiple Myeloma Clinical Trial
Official title:
Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma
Background and objective
The introduction of a proteasome inhibitor bortezomib has significantly improved response
rates and overall survival in patients with multiple myeloma (MM), and it has soon become the
cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However,
the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which
becomes an obstacle during treatment with bortezomib, either alone or in combination. Until
now, there are no consistent findings regarding the risk factors that may cause BiPN. There
is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk
factors of BiPN using retrospective analysis in a large cohort with longer observation period
as well as the relations between BiPN and gene polymorphisms, and to compare different routes
in the incidence of BiPN.
Methods
This is a retrospective cohort study with a sample size of about 400 MM patients treated ever
with at least one full cycle of bortezomib in the institution. All the patients enrolled need
to be adults (≧20 years ) with measurable M-component in either blood or urine. The
investigators will perform a retrospective chart review to collect clinical data, including
anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this
cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also
plan to perform genotyping for the possible genetic factors associated with development of
BiPN.
Expected contributions
The successful collaboration between clinical hematologist-oncologist and biopharmaceutical
researcher would result in the concrete evidence of efficacy and safety of bortezomib in
Taiwanese patients with MM. The findings in this large cohort study will unveil the risk
factors of BiPN, including the administration routes and ethnicity. As results, the
investigators would be able to provide the precision medicine-based bortezomib treatment
strategy to MM patients in Taiwan.
n/a
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