Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT03618602
Brief 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.
Detailed 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:
NCT03618602
Study Brief:
Protocol Section:
NCT03618602