An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02726581
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICALSpecified dose on specified days, IV (intravenous)
- Elotuzumab — BIOLOGICALSpecified dose on specified days, IV
- Pomalidomide — DRUGSpecified dose on specified days, PO (by mouth)
- Dexamethasone — DRUGSpecified dose on specified days, PO
Study Details
The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either: Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for all groups.
Key Dates
- Start date
- Aug 10, 2016
- Status verified
- Feb 2023
- Primary completion
- Mar 9, 2022
- Completion
- Mar 9, 2022
Study Design
- Enrollment
- 170 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Investigational ArmNivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
- Active Comparator: Control ArmPomalidomide and Dexamethasone Enrollment is closed for this arm
- Experimental: Exploratory ArmNivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month) ]
Locations (72)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0020 | Birmingham | Alabama | 35294-3300 | - |
| Local Institution - 0160 | Mobile | Alabama | 36608 | - |
| Local Institution - 0163 | Fayetteville | Arkansas | 72703 | - |
| Local Institution - 0118 | Bakersfield | California | 93309 | - |
| Local Institution - 0093 | Corona | California | 92879 | - |
| Local Institution - 0016 | Fountain Valley | California | 92708 | - |
| Local Institution - 0164 | La Jolla | California | 92037 | - |
| UC San Diego Moores Cancer Ctr | La Jolla | California | 92093-0698 | - |
| Local Institution - 0138 | Los Angeles | California | 90017 | - |
| Local Institution - 0155 | Los Angeles | California | 90095 | - |
| Local Institution - 0117 | Redondo Beach | California | 90277 | - |
| Local Institution - 0092 | Riverside | California | 92501 | - |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | - |
| Local Institution - 0113 | Santa Maria | California | 93454 | - |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | - |
| Poudre Valley Health Care | Fort Collins | Colorado | 80528 | - |
| Local Institution - 0116 | Grand Junction | Colorado | 81501 | - |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | - |
| Local Institution - 0147 | Washington D.C. | District of Columbia | 20007 | - |
| Local Institution - 0011 | Boynton Beach | Florida | 33426 | - |
| Florida Cancer Specialists S. | Fort Myers | Florida | 33916 | - |
| Local Institution - 0114 | Hollywood | Florida | 33021 | - |
| Cancer Specialists of North FL | Jacksonville | Florida | 32256 | - |
| Local Institution - 0082 | Pensacola | Florida | 32504 | - |
| Local Institution - 0126 | St. Petersburg | Florida | 33705 | - |
| Local Institution - 0130 | Tallahassee | Florida | 32308 | - |
| Local Institution - 0125 | West Palm Beach | Florida | 33401 | - |
| Local Institution - 0119 | Athens | Georgia | 30607 | - |
| Local Institution - 0009 | Atlanta | Georgia | 30318 | - |
| Local Institution - 0024 | Atlanta | Georgia | 30322 | - |
| Augusta University | Augusta | Georgia | 30912 | - |
| Local Institution - 0035 | Chicago | Illinois | 60612 | - |
| Local Institution - 0111 | Fort Wayne | Indiana | 46845 | - |
| Indiana University Cancer Ctr | Indianapolis | Indiana | 46202 | - |
| Local Institution - 0018 | Bethesda | Maryland | 20817 | - |
| Local Institution - 0006 | Baltimore | Massachusetts | 21229 | - |
| Local Institution - 0123 | Worcester | Massachusetts | 01655 | - |
| Local Institution - 0150 | Ypsilanti | Michigan | 48197 | - |
| Local Institution - 0137 | Hattiesburg | Mississippi | 39401 | - |
| St. Louis Cancer Care, Llp | Bridgeton | Missouri | 63044 | - |
| Local Institution - 0128 | Kansas City | Missouri | 64132 | - |
| Local Institution - 0049 | Springfield | Missouri | 65806 | - |
| Washington University | St Louis | Missouri | 63110 | - |
| Local Institution - 0079 | Lincoln | Nebraska | 68510 | - |
| Local Institution - 0076 | Flemington | New Jersey | 08822 | - |
| Local Institution - 0002 | Hackensack | New Jersey | 07601 | - |
| Local Institution - 0095 | New Brunswick | New Jersey | 08903 | - |
| Local Institution - 0142 | Paramus | New Jersey | 07652 | - |
| Local Institution - 0010 | Buffalo | New York | 14263 | - |
| Broome Oncology LLC | Johnson City | New York | 13790 | - |
| Local Institution - 0017 | New York | New York | 10065 | - |
| Mount Sinai Medical Center | New York | New York | 10029 | - |
| Local Institution - 0001 | Durham | North Carolina | 27710 | - |
| Local Institution - 0096 | Winston-Salem | North Carolina | 27157 | - |
| Local Institution - 0012 | Columbus | Ohio | 43219 | - |
| University Of Oklahoma | Oklahoma City | Oklahoma | 73104 | - |
| Local Institution - 0145 | Portland | Oregon | 97213 | - |
| Local Institution - 0136 | Lancaster | Pennsylvania | 17604 | - |
| Local Institution - 0021 | Philadelphia | Pennsylvania | 19104 | - |
| Local Institution - 0036 | Sayre | Pennsylvania | 18840 | - |
| Local Institution - 0152 | Greenville | South Carolina | 29605 | - |
| Local Institution - 0069 | Germantown | Tennessee | 38138 | - |
| Tennessee Oncology, PLLC - SCRI - PPDS | Nashville | Tennessee | 37203 | - |
| Baylor Research Institute | Dallas | Texas | 75246 | - |
| Local Institution - 0044 | Houston | Texas | 77090 | - |
| Local Institution - 0037 | San Antonio | Texas | 78229 | - |
| Local Institution - 0046 | Temple | Texas | 76508-0001 | - |
| Local Institution - 0022 | Ogden | Utah | 84403 | - |
| Local Institution - 0153 | Salt Lake City | Utah | 84106 | - |
| Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22908 | - |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | - |
| Local Institution - 0144 | Seattle | Washington | 98108 | - |
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