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Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Multicenter, Open-Label, Dose-Escalation Phase 1b Study of AEVI-007 in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical Trial Summary

This is a multicenter, open-label, dose-escalation Phase 1b study of AEVI-007 in subjects with relapsed or refractory Multiple Myeloma. The objectives of the study are to evaluate the safety, pharmacokinetics and pharmacodynamics of AEVI-007.

Clinical Trial Description

This was a multicenter, open-label, dose-escalation, sequential groups Phase 1b clinical study in subjects with R/R multiple myeloma. The study utilized a "3+3" design. Three subjects were enrolled at each dose, starting with the initial dose of 4 mg/kg. If there were no DLTs, escalation to the next cohort took place. If there was 1 DLT, then the cohort was to be expanded to 6. If there were no further DLTs, then escalation to the next dose took place. If there were 2 DLTs in the initial 3 subjects, or 2 in the expanded cohort of 6 subjects, then the maximally tolerated dose (MTD) had been exceeded and dose escalation stopped. The dose prior to the dose where DLT was observed was then the RP2D. To allow safety assessment, the dosing of subjects within each dose level was staggered, with at least 24 hours between each subject. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04671251
Study type Interventional
Source Avalo Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 15, 2020
Completion date March 30, 2022
View Details
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