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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental |
| |
| Dose 2 | Experimental |
| |
| Dose 3 | Experimental |
| |
| Dose 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMI-1271 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by frequency, severity and relatedness of AEs | Assessed by frequency, severity and relatedness of AEs | up to 6 months |
| Overall Response Rate | Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease | 18 months | |
| Time to response | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael O'Dwyer, MD | National University Ireland - Galway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vejle Hospital | Vejle | Denmark | ||||
| Medizinische Klinik/Abt. Innere Medizin V |
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| Time to progression | 18 months |
| Duration of response | 18 months |
| Progression free survival | 18 months |
| Overall survival | 18 months |
| Time versus plasma concentration profile of GMI-1271 | up to Day 23 of Cycle 1 (each cycle is 21 or 28 days) |
| Heidelberg |
| Germany |
| Cork University Hospital, Wilton | Cork | Ireland |
| Beaumont Hospital | Dublin | Ireland |
| National University Ireland - Galway | Galway | Ireland |
| Sheffield Teaching Hospital | Sheffield | England | United Kingdom |
| Saint James's University Hospital Leeds | Leeds | LS9 7TF | United Kingdom |
| University College London Hospitals | London | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000654285 | uproleselan |
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