Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT03210753|
Recruitment Status : Unknown
Verified May 2017 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : July 7, 2017
Last Update Posted : July 13, 2017
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.
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.
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
- peripheral neuropathy [ Time Frame: 2006/4/1-2016/12/31 ]identified the record of peripheral neuropathy, neuropathy, numbness, tingling, weakness symptoms by chart review
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210753
|Contact: Chou Jia-Shanemail@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Huang Shang-Yi 02-23123456 ext 63575 firstname.lastname@example.org|
|Principal Investigator:||Huang Shang-Yi||National Taiwan University Hospital|