Multiple Myeloma Clinical Trial
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Summary
The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.
Eligibility Criteria
Inclusion Criteria:
Must be ≥ 18 years at the time of signing informed consent.
Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
Must have documented disease progression during or after their last anti-myeloma therapy.
All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.
Exclusion Criteria:
Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.
Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
Non-secretory multiple myeloma.
Subjects with severe renal impairment requiring dialysis.
Previous therapy with pomalidomide.
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There are 197 Locations for this study
Mobile Alabama, 36608, United States
Tucson Arizona, 85710, United States
Tucson Arizona, 85724, United States
Berkeley California, 94704, United States
Fresno California, 93701, United States
Greenbrae California, 94904, United States
La Jolla California, 92083, United States
Los Angeles California, 90033, United States
Santa Rosa California, 95403, United States
Aurora Colorado, 80045, United States
Southington Connecticut, 06489, United States
Southington Connecticut, 06489, United States
Washington District of Columbia, 20037, United States
Boca Raton Florida, 33486, United States
Boynton Beach Florida, 33426, United States
Fort Lauderdale Florida, 33308, United States
Fort Lauderdale Florida, 33316, United States
Gainesville Florida, 32610, United States
Hollywood Florida, 33021, United States
West Palm Beach Florida, 33401, United States
Marietta Georgia, 30060, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46254, United States
Iowa City Iowa, 52242, United States
Paducah Kentucky, 42003, United States
New Orleans Louisiana, 70112, United States
Bangor Maine, 04401, United States
Bangor Maine, 04401, United States
Baltimore Maryland, 21229, United States
Bethesda Maryland, 20817, United States
Bethesda Maryland, 20817, United States
Hyattsville Maryland, 20782, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49546, United States
Lansing Michigan, 48912, United States
Royal Oak Michigan, 48073, United States
Duluth Minnesota, 55805, United States
Saint Louis Park Minnesota, 55416, United States
Jefferson City Missouri, 65203, United States
Kansas City Missouri, 64128, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Billings Montana, 59102, United States
Lincoln Nebraska, 68510, United States
Jersey City New Jersey, 07306, United States
Morristown New Jersey, 07960, United States
Somerville New Jersey, 08876, United States
Bronx New York, 10467, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
Stony Brook New York, 11794, United States
Valhalla New York, 10595, United States
Greenville North Carolina, 27834, United States
Rocky Mount North Carolina, 27804, United States
Canton Ohio, 44718, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43219, United States
Toledo Ohio, 43614, United States
Portland Oregon, 97213, United States
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57105, United States
Watertown South Dakota, 57201, United States
Watertown South Dakota, 57201, United States
Knoxville Tennessee, 37885, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Fort Sam Houston Texas, 78235, United States
Fort Sam Houston Texas, 78235, United States
Houston Texas, 77090, United States
Houston Texas, 77090, United States
Lubbock Texas, 79410, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98104, United States
Spokane Washington, 99208, United States
Wenatchee Washington, 98801, United States
Morgantown West Virginia, 25606, United States
Morgantown West Virginia, 25606, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53226, United States
St. Pölten , 3100, Austria
St. Pölten , 3100, Austria
Vienna , 1090, Austria
Vienna , 1090, Austria
Vienna , 1160, Austria
Vienna , 1160, Austria
Oshawa Ontario, L1G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Rimouski Quebec, G5L5T, Canada
Sherbrooke Quebec, J1H5N, Canada
Sherbrooke Quebec, J1H5N, Canada
Halifax , B3H 2, Canada
Halifax , B3H 2, Canada
Aarhus , 8000, Denmark
Copenhagen , 2100, Denmark
Odense , DK-50, Denmark
Vejle , 7100, Denmark
Vejle , 7100, Denmark
Helsinki , 290, Finland
Helsinki , 290, Finland
Hyvinkaa , 05850, Finland
Bayonne , 64109, France
Chalon sur Saone , 71100, France
Grenoble Cedex 09 , 38043, France
Lille , 59000, France
Lille , 59037, France
Lille , 59037, France
Nantes , 44035, France
Nantes , 44035, France
Paris , 75012, France
Pierre-Bénite Cedex , 69495, France
Poitiers Cedex , 86021, France
Poitiers Cedex , 86021, France
Rennes , 35033, France
Rennes , 35033, France
Toulouse Cedex , 31052, France
Tours cedex , 37044, France
Tours cedex , 37044, France
Berlin , D-133, Germany
Berlin , D-133, Germany
Dresden , 01307, Germany
Dresden , 01307, Germany
Essen , 45147, Germany
Essen , 45147, Germany
Freiburg , 79106, Germany
Freiburg , 79106, Germany
Heidelberg , 69120, Germany
Tuebingen , 72076, Germany
Tuebingen , 72076, Germany
Athens , 10676, Greece
Athens , 11528, Greece
Athens , 11528, Greece
Mezourlo , 41110, Greece
Mezourlo , 41110, Greece
Thessloniki , 57010, Greece
Thessloniki , 57010, Greece
Dublin , Dubli, Ireland
Dublin , Dubli, Ireland
Dublin , Dubli, Ireland
Dublin , Dubli, Ireland
Galway , ST46Q, Ireland
Galway , ST46Q, Ireland
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Bergamo , 24127, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Bologna , 40138, Italy
Catania , 95124, Italy
Modena , 41100, Italy
Pavia , 27100, Italy
Pavia , 27100, Italy
Pescara , 65124, Italy
Pescara , 65124, Italy
Reggio Emilia , 42100, Italy
Reggio Emilia , 42100, Italy
Rome , 00161, Italy
Rome , 00161, Italy
Salerno , 84131, Italy
San Giovanni Rotondo , 71013, Italy
Terni , 05100, Italy
Terni , 05100, Italy
Torino , 10126, Italy
Torino , 10126, Italy
Hitachi, Ibaraki , 317-0, Japan
Kamogawa , 296-8, Japan
Kamogawa , 296-8, Japan
Okayama , 701-1, Japan
Okayama , 701-1, Japan
Shibuya-ku , 150-8, Japan
Shibuya-ku , 150-8, Japan
Tachikawa , 190-0, Japan
Groningen , 9713 , Netherlands
Leeuwarden , 8934 , Netherlands
Rotterdam , 3015 , Netherlands
Rotterdam , 3015 , Netherlands
Oslo , 0372, Norway
Oslo , 0372, Norway
Trondheim , 7006, Norway
Brzozow , 36-20, Poland
Bydgoszcz , 85-16, Poland
Chorzow , 41-50, Poland
Gdansk , 80-95, Poland
Krakow , 31-50, Poland
Lodz , 93-51, Poland
Lodz , 93-51, Poland
Lublin , 20-08, Poland
Lublin , 20-08, Poland
Poznan , 60-56, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Warszawa , 02-78, Poland
Braga , 4710-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1649-, Portugal
Lisbon , 1400-, Portugal
Lisbon , 1400-, Portugal
Porto , 4200-, Portugal
Porto , , Portugal
Ponce , 00717, Puerto Rico
Moscow , 12318, Russian Federation
Moscow , 12528, Russian Federation
Moscow , 12528, Russian Federation
Nizhny Novgorod , 60312, Russian Federation
Saint Petersburg , 19102, Russian Federation
Badalona (Barcelona) , 08916, Spain
Badalona (Barcelona) , 08916, Spain
Barcelona , 08036, Spain
Barcelona , 08036, Spain
Bilbao , 48013, Spain
Madrid , 28041, Spain
Murcia , 30008, Spain
Murcia , 30008, Spain
Orense , 32005, Spain
Pamplona , 31008, Spain
Sevilla , 41014, Spain
Valencia , 46026, Spain
Falun , 79182, Sweden
Falun , 79182, Sweden
Gothenburg , 60 Go, Sweden
Luleå , SE-97, Sweden
Luleå , SE-97, Sweden
Stockholm , 14186, Sweden
Stockholm , 14186, Sweden
Sundsvall , S-856, Sweden
Ankara , 06590, Turkey
Ankara , 06590, Turkey
Ankara , 6500, Turkey
Ankara , 6500, Turkey
Ankara , Dikim, Turkey
Ankara , Dikim, Turkey
Antalya , 07050, Turkey
Eskisehir , 26480, Turkey
Gaziantep , 0, Turkey
Gaziantep , , Turkey
Istanbul , 34098, Turkey
Istanbul , 34390, Turkey
Istanbul , 34390, Turkey
Izmir , 35100, Turkey
Izmir , 35100, Turkey
Trabzon , 61080, Turkey
Bournemouth , BH7 7, United Kingdom
Canterbury Kent , CT1 3, United Kingdom
Canterbury Kent , CT1 3, United Kingdom
Edinburgh Scotland , EH4 2, United Kingdom
Edinburgh Scotland , EH4 2, United Kingdom
London , NW1 2, United Kingdom
London , NW1 2, United Kingdom
London , SE5 9, United Kingdom
Oxford , OX3 7, United Kingdom
Oxford , OX3 7, United Kingdom
Plymouth , PL6 8, United Kingdom
Plymouth , PL6 8, United Kingdom
Sheffield , S10 2, United Kingdom
Sheffield , S10 2, United Kingdom
Southampton , SO16 , United Kingdom
Southampton , SO16 , United Kingdom
Stoke-On-Trent , ST4 6, United Kingdom
Swansea , SA2 8, United Kingdom
Wolverhampton , WV10 , United Kingdom
Wolverhampton , WV10 , United Kingdom
Worcester , WR5 1, United Kingdom
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