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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000037-51 | EudraCT Number |
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elotuzumab | Experimental | This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elotuzumab | Drug | Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected. | Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study. |
| Measure | Description | Time Frame |
|---|---|---|
| All serious adverse events (SAEs) will be collected. | Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study. | |
| All Grade 5 adverse events (AEs) will be collected. |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0020 | Tucson | Arizona | 85715 | United States | ||
| Local Institution - 0017 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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|
| Dexamethasone | Drug | Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study. |
|
| Dexamethasone | Drug | Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. |
|
| Lenalidomide | Drug | Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study. |
|
|
| Bortezomib | Drug | Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study. |
|
|
| Pomalidomide | Drug | Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study. |
|
|
| Nivolumab | Drug | Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. |
|
|
| Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study. |
| All adverse events (AEs) previously not reported will be collected. | Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study. |
| All adverse events (AEs) leading to discontinuation will be collected. | Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study. |
| Bakersfield |
| California |
| 93309 |
| United States |
| Local Institution - 0022 | Fountain Valley | California | 92708 | United States |
| Local Institution - 0016 | West Hollywood | California | 90069 | United States |
| Local Institution - 0019 | Denver | Colorado | 80218 | United States |
| Local Institution - 0021 | Jacksonville | Florida | 32256 | United States |
| Local Institution - 0042 | St. Petersburg | Florida | 33705 | United States |
| Local Institution - 0009 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 0003 | Indianapolis | Indiana | 46260 | United States |
| Local Institution - 0002 | Boston | Massachusetts | 02215 | United States |
| Local Institution - 0008 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0004 | New York | New York | 10029 | United States |
| Local Institution - 0001 | Bethlehem | Pennsylvania | 18015 | United States |
| Local Institution - 0018 | Dallas | Texas | 75231 | United States |
| Local Institution - 0034 | Heidelberg | Victoria | 3084 | Australia |
| Local Institution - 0023 | Antwerp | 2060 | Belgium |
| Local Institution - 0011 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0010 | Halifax | B3H 2Y9 | Canada |
| Local Institution - 0035 | Athens | 11528 | Greece |
| Local Institution - 0036 | Budapest | 1097 | Hungary |
| Local Institution - 0015 | Ancona | 60126 | Italy |
| Local Institution - 0012 | Florence | 50134 | Italy |
| Local Institution - 0013 | Genova | 16132 | Italy |
| Local Institution - 0043 | Ravenna | 48121 | Italy |
| Local Institution - 0044 | Terni | 05100 | Italy |
| Local Institution - 0014 | Torino | 10126 | Italy |
| Local Institution - 0046 | Aomori | Aomori | 0308553 | Japan |
| Local Institution - 0047 | Shibukawa-shi | Gunma | 3770280 | Japan |
| Local Institution - 0049 | Osaka | Osaka | 5300012 | Japan |
| Local Institution - 0048 | Koto-ku | Tokyo | 135-8550 | Japan |
| Local Institution - 0050 | Chiba | 260-8677 | Japan |
| Local Institution - 0045 | Kasama-shi | 3091793 | Japan |
| Local Institution - 0027 | Chorzów | 41-500 | Poland |
| Local Institution - 0026 | Warsaw | 02-106 | Poland |
| Local Institution - 0039 | Warsaw | 02-776 | Poland |
| Local Institution - 0028 | Bucharest | 030171 | Romania |
| Local Institution - 0029 | Iași | 700483 | Romania |
| Local Institution - 0041 | Barcelona | 08036 | Spain |
| Local Institution - 0030 | Toledo | 45004 | Spain |
| Local Institution - 0031 | Cebeci Ankara | 06620 | Turkey (Türkiye) |
| Local Institution - 0032 | London | EC1A 7BE | 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 |
|---|---|
| C546027 | elotuzumab |
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| D000069286 | Bortezomib |
| C467566 | pomalidomide |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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