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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to determine the safety and in vivo persistence and expansion of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.
To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a > 4 fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56 (CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple myeloma (AMM) defined as gene expression profile (GEP) 70 gene score>-0.26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENK Cell Infusion | Experimental | Expanded Natural Killer Cell Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENK Cell Infusion | Drug | Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment | Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frits Van Rhee, M.D., Phd | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Science | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ENK Cell Infusion | Expanded Natural Killer Cell Infusion ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data includes only those participants that initiated study therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | ENK Cell Infusion | Expanded Natural Killer Cell Infusion ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment | Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level | Posted | Count of Participants | Participants | 7 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENK Cell Infusion | Expanded Natural Killer Cell Infusion ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 1 Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frits van Rhee | University of Arkansas for Medical Sciences | 501-526-6990 | vanrheefrits@uams.edu |
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| ID | Term |
|---|---|
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D006942 | Hypergammaglobulinemia |
| D001796 | Blood Protein Disorders |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| Grade 2 Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Grade 1 Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Grade 1 Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Grade 1 Cataract | Eye disorders | Systematic Assessment |
|
| Grade 1 Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Grade 1 Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Grade 1 Edema-limb | General disorders | Systematic Assessment |
|
| Grade 1 Hot Flashes | Vascular disorders | Systematic Assessment |
|
| Grade 1 Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Grade 1 Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Grade 1 Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Grade 3 Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Grade 1 Injection Site Reaction | General disorders | Systematic Assessment |
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| Grade 2 Injection Site Reaction | General disorders | Systematic Assessment |
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| Gade 1 Fatigue | General disorders | Systematic Assessment |
|
| Grade 1 Pain - NOS | General disorders | Systematic Assessment |
|
| Grade 1 Mood Alteration | Psychiatric disorders | Systematic Assessment |
|
| Grade 1 Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Grade 1 Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Grade 2 Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Grade 1 Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Grade 1 Rigors/Chills | General disorders | Systematic Assessment |
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| Grade 1 SGOT (AST) Increase | Hepatobiliary disorders | Systematic Assessment |
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| Grade 1 SGPT (ALT) Increase | Hepatobiliary disorders | Systematic Assessment |
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| Grade 1 Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Grade 2 Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Grade 2 Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010265 | Paraproteinemias |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |