Spots Global Cancer Trial Database for Safety, Pharmacokinetics and Efficacy Study of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients

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Trial Identification

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

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

Study ID: NCT03618602

Conditions

Refractory Multiple Myeloma

Recurrent Multiple Myeloma

Interventions

Bisthianostat

Study Description

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.