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NCT02514239: Phase 1 - Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Myeloma Patients

Updated: Sep 2, 2022

An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients

AMG420

The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for further development will be determined. This will depend on the safety data, pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary objectives are to document the safety and tolerability of BI 836909, to perform pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in terms of parameters of efficacy.


Sponsor

 

ClinicalTrials.gov Identifier: NCT02514239


Official Title: An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients

First Posted: August 3, 2015


Click here for details on ClinicalTrials.gov

 
 

PMID: 31895611

J Clin Oncol; March 2020

Anti-B-Cell Maturation Antigen BiTE Molecule AMG 420 Induces Responses in Multiple Myeloma

 

Pacanalotamab

AMG 420

BI 836909

 

Locations

Europe

France

Germany









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