Relapsed and/or Refractory Multiple Myeloma Clinical Trial
Official title:
A Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM.
The drug that is being tested in this study is called TAK-573. The study will evaluate the
safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TAK-573 when used in
combination with dexamethasone and either bortezomib, pomalidomide or cyclophosphamide in
participants with RRMM.
The study will be conducted in 2 phases: Dose Escalation Phase and Dose Expansion Phase. The
study will enroll approximately 135 participants (approximately 60 participants in Dose
Escalation Phase and approximately 75 participants in Dose Expansion Phase). The dose
escalation phase will determine the recommended dose of TAK-573 along with the combination
agents for the dose expansion phase.
This multi-center trial will be conducted in the United States, Germany, France, Spain, and
Canada. The overall time to participate in this study is approximately 3 years. Participants
will be followed up for 30 days after the last dose of study drug for a follow-up assessment.
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