This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as adjunct to standard of care chemotherapy used to treat this disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Vejle Hospital
Vejle, Denmark
Medizinische Klinik/Abt. Innere Medizin V
Heidelberg, Germany
Cork University Hospital, Wilton
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
Safety assessed by frequency, severity and relatedness of AEs
Assessed by frequency, severity and relatedness of AEs
Time frame: up to 6 months
Overall Response Rate
Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response
Time frame: up to 18 months
Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease
Time frame: 18 months
Time to response
Time frame: 18 months
Time to progression
Time frame: 18 months
Duration of response
Time frame: 18 months
Progression free survival
Time frame: 18 months
Overall survival
Time frame: 18 months
Time versus plasma concentration profile of GMI-1271
Time frame: up to Day 23 of Cycle 1 (each cycle is 21 or 28 days)
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National University Ireland - Galway
Galway, Ireland
Sheffield Teaching Hospital
Sheffield, England, United Kingdom
Saint James's University Hospital Leeds
Leeds, United Kingdom
University College London Hospitals
London, United Kingdom