Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/30/2018
Start Date:January 7, 2013
End Date:May 1, 2022

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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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.


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.
We found this trial at
76
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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6405 N Federal Hwy # 300
Fort Lauderdale, Florida 33308
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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Aurora, Colorado 80045
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Baltimore, Maryland 21229
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Bangor, Maine 04401
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Berkeley, California 94704
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Boca Raton, Florida 33486
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Boynton Beach, Florida 33426
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Cleveland, Ohio 44109
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Detroit, Michigan 48202
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Duluth, Minnesota 55805
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6405 N Federal Hwy # 300B
Fort Lauderdale, Florida 33316
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3551 Roger Brooke Drive
Fort Sam Houston, Texas 78235
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Greenbrae, California 94904
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Greenville, North Carolina 27834
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Houston, Texas 77090
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Hyattsville, Maryland 20782
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Indianapolis, Indiana 46254
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Jefferson City, Missouri 65203
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La Jolla, California 92083
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Lansing, Michigan 48912
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Lincoln, Nebraska 68510
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Mobile, Alabama 36608
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Morgantown, West Virginia 25606
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Morristown, New Jersey 07960
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New Orleans, Louisiana 70112
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New York, New York 10029
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225 Medical Center Drive
Paducah, Kentucky 42003
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Rocky Mount, North Carolina 27804
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Royal Oak, Michigan 48073
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621 South New Ballas Road
Saint Louis, Missouri 63141
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Saint Louis Park, Minnesota 55416
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Salt Lake City, Utah 84106
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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3883 Airway Drive, Suite 300
Santa Rosa, California 95403
(707) 521-8830
Sutter Pacific Medical Foundation Sutter Pacific Medical Foundation doctors offer primary, specialty and complex medical...
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Seattle, Washington 98104
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Sioux Falls, South Dakota 57105
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Somerville, New Jersey 08876
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Southington, Connecticut 06489
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Spokane, Washington 99208
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Stony Brook, New York 11794
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Washington, District of Columbia 20037
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West Palm Beach, Florida 33401
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