Status and phase
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Study type
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Identifiers
About
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM).
The primary objectives:
The secondary objectives:
Full description
This is a multicenter, open label, dose escalation, Phase I / II study in subjects with relapsed and/or refractory MM. Up to 24 subjects to be enrolled in the Phase I to determine the RP2D. Up to 77 additional evaluable subjects to be enrolled in Phase II for a maximum up to 101 subjects treated in the study. Study centers in the USA and the UK will participate in Phase I and II. Centers in the Philippines will be participating in Phase II only. The planned enrollment period is 22 months and the planned study duration is 28 months.
Enrollment
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Inclusion and exclusion criteria
Accepts Healthy Volunteers: No
Inclusion Criteria:
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
95 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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