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Safety, Pharmacokinetics and Efficacy Study of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients

Refractory Multiple Myeloma Clinical Trial

Official title:
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients

Clinical Trial Summary

This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and efficacy of Bisthianostat in refractory or recurrent multiple myeloma patients.

Clinical Trial Description

This is a first-in-human, single center, open-label, single arm, dose escalating phase I study. This study will be conducted in 3 parts.

Phase A : Patients will receive single dose of bisthianostat to evaluate the single-dose pharmacokinetics and safety.

Phase B: After single-dose phase, patients will receive multiple dose bisthianostat for 4 weeks on day 1,4,11,14,18,21,25,28 to evaluate the multiple-dose pharmacokinetics and safety

Phase C: Patients will continue on the study if they benefit from the drug and not experience any serious side effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03618602
Study type Interventional
Source Shanghai Theorion Pharmaceutical Co Ltd.
Contact Jian Hou, MD
Phone 00862168383144
Email houjian@medmail.com.cn
Status Recruiting
Phase Phase 1
Start date April 25, 2018
Completion date July 2020
View Details
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