Last updated on June 2020

A Study to Investigate the Safety Tolerability Efficacy Pharmacokinetics and Immunogenicity of TAK-573 in Participants With Refractory Multiple Myeloma (MM)


Brief description of study

The purpose of this study is to determine the safety and tolerability of single agent TAK-573 in participants with relapsed/refractory MM in Phase 1, and to provide a preliminary evaluation of the clinical activity of TAK-573 as a single agent and in combination with dexamethasone in participants with relapsed/refractory MM in Phase 2.

Detailed Study Description

The drug being tested in this study is called TAK-573 as single agent and in combination with dexamethasone. The study will determine the safety and tolerability of TAK-573 as single agent and in combination with dexamethasone in participants with relapsed/refractory MM. The study consists of 2 Phases, 1 and 2.

The study will enroll approximately 51 and 100 participants in Phase 1 and 2 respectively. Participants will be randomly assigned to one of the following treatment groups in each

Phase
  • Phase 1 Schedule A: TAK-573 0.001 to 14 mg/kg
  • Phase 1 Schedule B: TAK-573 TBD
  • Phase 1 Schedule C: TAK-573 TBD
  • Phase 1 Schedule D: TAK-573 TBD
  • Phase 2: TAK-573 TBD

The Phase 1 portion of the study will follow a 3+3 dose escalation design to evaluate once-weekly up to 4 different schedules of administration of TAK-573 starting at 0.001 mg/kg for DLT evaluation and to determine the maximum tolerated dose (MTD) or an optimal biological dose (OBD) for assessments in Phase 2.

This multi-center trial will be conducted in the United States. The maximum treatment duration in this study is up to 12 months and overall time to participate in the study is approximately up to 40 months. Participants will make 37 visits to the clinic, and will be contacted every 12 weeks for post treatment follow-up. Participants will be followed up for survival until death, lost to follow-up, consent withdrawal, or study termination by the sponsor, whichever occurs first.

Clinical Study Identifier: NCT03215030

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Recruitment Status: Open


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