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: | 3/16/2019 |
Start Date: | January 7, 2013 |
End Date: | May 1, 2022 |
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.
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
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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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
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
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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New York Medical College The College was founded in 1860 by a group of New...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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3551 Roger Brooke Drive
Fort Sam Houston, Texas 78235
Fort Sam Houston, Texas 78235
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1441 Eastlake Ave
Los Angeles, California 90033
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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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Marietta, Georgia 30060
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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225 Medical Center Drive
Paducah, Kentucky 42003
Paducah, Kentucky 42003
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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
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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Spartanburg, South Carolina 29303
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