A phase 2 study of SRT501 (resveratrol) with bortezomib for patients with relapsed and/or refractory multiple myeloma
clinical trial · 2013
LINK
SUMMARY
Registered trial (ClinicalTrials.gov NCT00920556) of Sirtris/GlaxoSmithKline's proprietary micronized resveratrol drug candidate SRT501, in combination with bortezomib, in relapsed/refractory multiple myeloma. The study was stopped after 5 of 24 patients receiving SRT501 developed renal failure (median time to onset 7 days), with all five also reporting nausea and vomiting and two requiring temporary hemodialysis; the paper concludes the combination demonstrated an unacceptable safety profile and minimal efficacy in this patient population, highlighting the risks of novel-drug development in such populations (paraphrased from the paper's own conclusion, confirmed against the abstract on PubMed and against a secondary review's verbatim quotation of the same sentence, PMC3782695, though the mechanical `verify-quotes` fetcher could not independently confirm PMC's rendering, so the sentence is not asserted here as a verbatim quotation). DOI resolved via Crossref; title and author list match. Primary clinical-trial report.
NOTES
The clinical disconfirmation: Sirtris/GSK’s lead resveratrol drug candidate, developed directly from the 2003 mechanistic finding, was terminated in human testing for a serious adverse event rather than for lack of efficacy alone.