The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone (PomDex) in Phase 1, and to provide a preliminary evaluation of the clinical activity of TAK-079 monotherapy in Phase 2a in participants with relapsed/refractory multiple myeloma.
The information from the study may be used to:
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Prior therapy should meet all the following criteria:
Participants in the dose Escalation Cohort (escalation phase) and participants in the dose Confirmation Cohort;
Participants in the Combination Cohort (TAK-079 added to PomDex cohort only):
Note: Refractory is defined as at least a 25% increase in M-protein (response of stable disease during prior therapy) or PD during treatment or within 60 days after last dose of prior therapy.
The following is a listing of trial locations that are open and accepting patients.
November 13, 2019
In the 14 patients receiving at least 4 cycles of therapy by the time of the data cutoff, the objective response rate (ORR; partial response or better) was 43%, 1 patient's response deepened over time to VGPR, the clinical benefit rate (minimal response or better) was 57%. Within this group, in patients never exposed to anti-CD38 therapy, the ORR was 46%.
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You can explore trial locations from around the US and connect directly with a trial coordinator.Find Nearby Locations
You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.
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