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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
To provide elotuzumab treatment for single-patient use.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elotuzumab | Drug | Elotuzumab will be administered intravenously at a dose of 10mg/kg weekly (Days 1, 8, 15, and 22 of a 4-233k cycle) of the first 2 cycles and every 2 weeks (Day 1 and Day 15) thereafter. A window of -1 to +3 days is permitted in Cycles 1 and 2. In Cycle 1 and 2, an elotuzumab dose that falls outside of the pre-specified window must be skipped. In Cycles 3 and beyond, elotuzumab dosing may be delayed for up to 1 week as clinically indicated. If unable to administer within 1 week, then the dose should be skipped and resumption of the elotuzumab continues per the guidance document defined schedule. In addition the following premedication must also be administered 30-90 minutes prior to any elotuzumab:
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Inclusion Criteria:
Signed Written Informed Consent
a) Before any program procedures are performed, the patient will have the details of the program described to him or her, and she or he will be given a written informed consent document to read. Then, if the patient consents to participate in the program, she or he will indicate that consent by signing and dating the informed consent document in the presence of program personnel.
Other Criteria
a) Patients must be willing to refrain from blood donations during program drug therapy and for 8 weeks after therapy.
Age and Reproductive Status
Exclusion Criteria:
Sex and Reproductive Status
Other Exclusion Criteria
Elotuzumab CA204022 BMS-901608 Expanded Access Guidance Document 23 Eligibility criteria for this program have been carefully considered to ensure the safety of the program patients and to ensure that the results of the program can be used. It is imperative that patients fully meet all eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Sundar Jagannath, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School.of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C546027 | elotuzumab |
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| 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 |