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Withdrawal of study support
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Altor BioScience | INDUSTRY |
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This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell transplant. Natural killer cells are a special type of white blood cells that are already present in the body which have the ability to kill myeloma cells. In this study, natural killer cells will be collected and then treated in a laboratory to activate and 'expand' the number of cells to increase the dose and the anti-myeloma activity of the cells before they are transfused back into the subject. Elotuzumab is a protein drug approved by the United States Food and Drug Administration (FDA) for patients with previously treated multiple myeloma and works by activating natural killer cells already present in the body and targeting a protein called SLAMF7 which is present on both natural killer cells and myeloma cells. The investigators hope that administering Elotuzumab in combination with ENK cells will enhance the anti-myeloma activity of the ENK cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment | Experimental | Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26; Melphalan 200 mg/m2 Ivia intravenous infusion on day -3; ASCT on day -2; ENK infusion on day 0; ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elotuzumab | Drug | Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Myeloma Response | Response will be measured according to International Myeloma Working Group (IMWG) Criteria | 98 days post-ENK infusion (100 days post-ASCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Frequency and severity of treatment-related adverse events | within 98 days post-ENK infusion (100 days post-ASCT) |
| Persistence of ENK cells by flow cytometry and/or cytometry by time of flight (CyTOF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frits van Rhee, MD, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| Melphalan | Drug | Melphalan 200 mg/m2 Ivia intravenous infusion on day -3 |
|
| Autologous Stem Cell Transplant (ASCT) | Procedure | ASCT on day -2 |
|
| Expanded Natural Killer (ENK) Cells | Biological | ENK cell infusion on day 0 |
|
| ALT-803 | Drug | ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22 |
|
|
| within 98 days post-ENK infusion (100 days post-ASCT) |
| 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 |
|---|---|
| C546027 | elotuzumab |
| D008558 | Melphalan |
| D002452 | Cell Count |
| C582303 | ALT-803 |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
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