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About
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.
Full description
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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Inclusion criteria
Received >=2 prior lines of therapy, including treatment with lenalidomide and a proteasome inhibitor.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
With measurable disease, defined as at least 1 of the following:
Has adequate organ function as determined by the following laboratory values:
Has received the final dose of any of the following treatments/procedures within the specified minimum intervals before first dose of TAK-573:
Exclusion criteria
Primary purpose
Allocation
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Masking
0 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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