Relapsed/Refractory Multiple Myeloma Clinical Trial
Official title:
Phase I, Open Label, Dose Escalation Study to Investigate the Tolerability and Efficacy of APO010 in Patients With Relapsed/Refractory Multiple Myeloma Selected by Drug Response Predictor (DRP)
Multicentre, open label, uncontrolled, phase I pharmacokinetic study, to determine the Maximum Tolerated Dose (MTD) of APO010 administered intravenously on D1, D8 and D15 followed by a one-week drug rest, in patients with multiple myeloma for who have relapsed or are refractory to 2 (in high-risk patients 1) or more different prior therapies and who have Drug Response Predictor (DRP) for APO010 indicating a higher likelihood for response to APO010. The study will contain an extension phase where the recommended Dose will be tested on additional patients.
APO010 is a novel investigational antitumour agent. It is a recombinant form of human Fas
ligand (FasL), a protein with the function of inducing programmed cell death (apoptosis).
Preclinical studies indicate that multiple myeloma is sensitive for APO010. Estimation of DRP
for APO010 in myeloma patients suggests that it may be possible to identify patients with
high and low likelihood for response, and thereby allocate the predicted high likelihood
patients to the treatment. Preclinical results indicate that, in comparison with other single
agents, APO010 exercises superior anti-tumour effect by inducing apoptosis.
The study will include patients with multiple myeloma who have relapsed or are refractory to
2 (in high-risk patients 1) or more different prior therapies, including IMiDs and PI and who
have Drug Response Predictor (DRP) for APO010 indicating a higher likelihood for response to
APO010.
This study is a multicentre, open label, uncontrolled, phase I, dose escalation,
pharmacokinetic study, to determine the Maximum Tolerated Dose (MTD) of APO010 administered
intravenously on D1, D8 and D15 followed by a one-week drug rest i.e. cycle duration is 4
weeks. The study will contain an extension phase where the Recommended Dose will be tested on
additional patients.
The primary endpoint is determination of the Maximum Tolerated Dose (MTD)based upon first
cycle drug-related dose-limiting toxicity and the recommended dose of APO010. Safety will be
evaluated during the study and for 30 days after the last administration of study drug.
Adverse events and laboratory studies will be graded according to NCI-CTCAE v. 4.03.
The proportion of patients with positive HADA assessment will be investigated and a
description of any objective tumour response based on International Myeloma Working Group
criteria and from changes in M-protein and iFLC.
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