Multiple Myeloma Clinical Trial
Official title:
A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.
Phase I/IIa, open-label, 3 + 3 multi-dose escalation study. The Phase I part of the study was
to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3
rules was chosen to define the MTD.
The Phase IIa part was to include the MTD/recommended phase II dose (RPTD) expansion cohort
in which descriptive statistical methods for evaluation of response, time to event endpoints,
and safety were to be performed.
35 subjects in the Safety population, 34 subjects in the ITT and PP populations.
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