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.
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.
In addition, after the MTD is defined, must also be either refractory to or intolerant of at least one anti-CD38 monoclonal antibody.
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
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