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To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.
Allocation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Elotuzumab + Lirilumab | Experimental | Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response |
|
| Arm 2: Elotuzumab + Urelumab | Experimental | Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elotuzumab | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety | adverse events (AEs), serious adverse events (SAEs) | During treatment and first 100 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) | At different timepoints approximately up to 2.5 years | |
| Objective Response rate (ORR) | At different timepoints approximately up to 2.5 years | |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Subjects must have histological confirmation of multiple myeloma with measurable disease (per International Myeloma Working Group (IMWG) criteria):
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Arkansas For Medical Sciences | Little Rock | Arkansas | United States | |||
| The Sidney Kimmel Comprehensive Cancer Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Lirilumab |
| Drug |
|
|
| Urelumab | Drug |
|
|
| Median Duration of Response (mDOR) |
| At different timepoints approximately up to 2.5 years |
| Median Time to Response (mTTR) | At different timepoints approximately up to 2.5 years |
| Progression-free survival rate (PFSR) | At different timepoints approximately up to 2.5 years |
| M-protein levels | At different timepoints approximately up to 2.5 years |
| Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects | At different timepoints approximately up to 2.5 years |
| Maximum concentration of Urelumab (Cmax) | At different timepoints approximately up to 2.5 years |
| Maximum concentration of Lirilumab (Cmax) | At different timepoints approximately up to 2.5 years |
| Area under the Curve (AUCTAU) of Urelumab | At different timepoints approximately up to 2.5 years |
| Area under the Curve (AUCTAU) of Lirilumab | At different timepoints approximately up to 2.5 years |
| Volume of distribution (Vz) for Urelumab | At different timepoints approximately up to 2.5 years |
| Total Clearance (CLT) of Urelumab | At different timepoints approximately up to 2.5 years |
| Total Clearance (CLT) of Lirilumab | At different timepoints approximately up to 2.5 years |
| Concentration at the end of infusion (ceoinf) of Urelumab | At different timepoints approximately up to 2.5 years |
| Concentration at the end of infusion (ceoinf) of Elotuzumab | At different timepoints approximately up to 2.5 years |
| Concentration at the end of infusion (ceoinf) of Lirilumab | At different timepoints approximately up to 2.5 years |
| Cmin will be capture at steady state of all study subjects | At different timepoints approximately up to 2.5 years |
| Occurence of Specific anti-drug antibodies (ADA) to each study drug | At different timepoints approximately up to 2.5 years |
| ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects | At different timepoints approximately up to 2.5 years |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution | Pamplona | Navarre | 31008 | Spain |
| 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 |
| C000723331 | lirilumab |
| C000620833 | urelumab |
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