A Phase 1 / 2a Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-573 (Formerly TEV-48573) Administered Intravenously as a Single Agent in Patients With Refractory Multiple Myeloma
18 Years and older, Male and Female
The purpose of this Phase 1 portion of the study is to determine the safety and tolerability of TAK-573 monotherapy in participants with refractory multiple myeloma (MM) and Phase 2a portion of the study is to provide a preliminary evaluation of the clinical activity of TAK-573 monotherapy in participants with refractory MM.
The drug being tested in this study is called TAK-573. TAK-573 is being tested to treat
participants who have refractory MM. The study consists of 2 Phases, 1 and 2a. The study will
enroll approximately 51 and 18 participants in Phase 1 and 2a respectively. Participants will
be randomly assigned (by chance, like flipping a coin) to one of the following treatment
groups in each Phase:
Phase 1: TAK-573 0.001 mg/kg Phase 1: TAK-573 0.01 mg/kg Phase 1: TAK-573 0.1 mg/kg Phase 1:
TAK-573 0.2 mg/kg Phase 1: TAK-573 0.4 mg/kg Phase 1: TAK-573 0.8 mg/kg Phase 1: TAK-573 1.6
mg/kg Phase 1: TAK-573 3 mg/kg Phase 1: TAK-573 6 mg/kg Phase 1: TAK-573 10 mg/kg Phase 1:
TAK-573 15 mg/kg Phase 2: TAK-573 TBD
The Phase 1 portion of the study will follow a 3+3 dose escalation design to evaluate
once-weekly administration of TAK-573 for DLT and to determine the maximum tolerated dose
(MTD) for assessments in Phase 2a.
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 31 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, loss to follow-up, consent withdrawal, or study termination by the
sponsor, whichever occurs first.