Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, Pomalidomide
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pomalidomide Type: Drug
Name: Bortezomib Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to compare the efficacy of the combination of Pomalidomide, Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of Bortezomib and Dexamethasone
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Must be ≥ 18yrs 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:

- Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 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.
Locations
Celgene Study Site
Mobile, Alabama, United States
Status: Recruiting
Celgene Study Site
Tucson, Arizona, United States
Status: Recruiting
Celgene Study Site
Tucson, Arizona, United States
Status: Recruiting
Celgene Study Site
Berkeley, California, United States
Status: Recruiting
Celgene Study Site
Greenbrae, California, United States
Status: Recruiting
Celgene Study Site
La Jolla, California, United States
Status: Withdrawn
Celgene Study Site
Los Angeles, California, United States
Status: Recruiting
Celgene Study Site
Santa Rosa, California, United States
Status: Recruiting
Celgene Study Site
Aurora, Colorado, United States
Status: Recruiting
Celgene Study Site
Southington, Connecticut, United States
Status: Recruiting
Celgene Study Site
Washington, District of Columbia, United States
Status: Recruiting
Celgene Study Site
Boca Raton, Florida, United States
Status: Recruiting
Celgene Study Site
Boynton Beach, Florida, United States
Status: Withdrawn
Celgene Study Site
Ft. Lauderdale, Florida, United States
Status: Recruiting
Celgene Study Site
Ft. Lauderdale, Florida, United States
Status: Recruiting
Celgene Study Site
Hollywood, Florida, United States
Status: Withdrawn
Celgene Study Site
West Palm Beach, Florida, United States
Status: Recruiting
Celgene Study Site
Marietta, Georgia, United States
Status: Recruiting
Celgene Study Site
Indianapolis, Indiana, United States
Status: Recruiting
Celgene Study Site
Iowa City, Iowa, United States
Status: Withdrawn
Celgene Study Site
Paducah, Kentucky, United States
Status: Recruiting
Celgene Study Site
New Orleans, Louisiana, United States
Status: Recruiting
Celgene Study Site
Brewer, Maine, United States
Status: Recruiting
Celgene Study Site
Baltimore, Maryland, United States
Status: Recruiting
Celgene Study Site
Baltimore, Maryland, United States
Status: Recruiting
Celgene Study Site
Bethesda, Maryland, United States
Status: Recruiting
Celgene Study Site
Grand Rapids, Michigan, United States
Status: Recruiting
Celgene Study Site
Lansing, Michigan, United States
Status: Recruiting
Celgene Study Site
Royal Oak, Michigan, United States
Status: Recruiting
Celgene Study Site
Duluth, Minnesota, United States
Status: Recruiting
Celgene Study Site
St. Louis, Minnesota, United States
Status: Recruiting
Celgene Study Site
Jefferson City, Missouri, United States
Status: Recruiting
Celgene Study Site
Kansas City, Missouri, United States
Status: Recruiting
Celgene Study Site
Springfield, Missouri, United States
Status: Recruiting
Celgene Study Site
St. Louis, Missouri, United States
Status: Recruiting
Celgene Study Site
Billings, Montana, United States
Status: Recruiting
Celgene Study Site
Lincoln, Nebraska, United States
Status: Recruiting
Celgene Study Site
Jersey City, New Jersey, United States
Status: Recruiting
Celgene Study Site
Morristown, New Jersey, United States
Status: Withdrawn
Celgene Study Site
Somerville, New Jersey, United States
Status: Recruiting
Celgene Study Site
Bronx, New York, United States
Status: Recruiting
Celgene Study Site
New York, New York, United States
Status: Recruiting
Celgene Study Site
Stony Brook, New York, United States
Status: Recruiting
Celgene Study Site
Valhalla, New York, United States
Status: Recruiting
Celgene Study Site
Greenville, North Carolina, United States
Status: Recruiting
Celgene Study Site
Rocky Mount, North Carolina, United States
Status: Recruiting
Celgene Study Site
Canton, Ohio, United States
Status: Recruiting
Celgene Study Site
Cleveland, Ohio, United States
Status: Recruiting
Celgene Study Site
Columbus, Ohio, United States
Status: Recruiting
Celgene Study Site
Toledo, Ohio, United States
Status: Recruiting
Celgene Study Site
Portland, Oregon, United States
Status: Recruiting
Celgene Study Site
Charleston, South Carolina, United States
Status: Withdrawn
Celgene Study Site
Spartanburg, South Carolina, United States
Status: Recruiting
Celgene Study Site
Sioux Falls, South Dakota, United States
Status: Withdrawn
Celgene Study Site
Watertown, South Dakota, United States
Status: Recruiting
Celgene Study Site
Knoxville, Tennessee, United States
Status: Recruiting
Celgene Study Site
Nashville, Tennessee, United States
Status: Recruiting
Celgene Study Site
Dallas, Texas, United States
Status: Recruiting
Celgene Study Site
Fort Sam Houston, Texas, United States
Status: Recruiting
Celgene Study Site
Houston, Texas, United States
Status: Recruiting
Celgene Study Site
Lubbock, Texas, United States
Status: Recruiting
Celgene Study Site
Salt Lake City, Utah, United States
Status: Withdrawn
Celgene Study Site
Seattle, Washington, United States
Status: Recruiting
Celgene Study Site
Spokane, Washington, United States
Status: Recruiting
Celgene Study Site
Wenatchee, Washington, United States
Status: Recruiting
Celgene Study Site
Morgantown, West Virginia, United States
Status: Recruiting
Celgene Study Site
Madison, Wisconsin, United States
Status: Recruiting
Celgene Study Site
Milwaukee, Wisconsin, United States
Status: Recruiting
Celgene Study Site
Halifax, Nova Scotia, Canada
Status: Recruiting
Celgene Study Site
Aarhus C, Denmark
Status: Recruiting
Celgene Study Site
Odense C, Denmark
Status: Recruiting
Celgene Study Site
Bayonne, France
Status: Recruiting
Celgene Study Site
Grenoble, France
Status: Recruiting
Celgene Study Site
Lille Cedex, France
Status: Recruiting
Celgene Study Site
Nantes, France
Status: Recruiting
Celgene Study Site
Paris, France
Status: Recruiting
Celgene Study Site
Pierre-Benite, France
Status: Recruiting
Celgene Study Site
Tours, France
Status: Recruiting
Celgene Study Site
Athens, Greece
Status: Recruiting
Celgene Study Site
Athens, Greece
Status: Recruiting
Celgene Study Site
Exochi, Thessaloniki, Greece
Status: Recruiting
Celgene Study Site
Mexourlo, Larissa, Greece
Status: Recruiting
Celgene Study Site
Dublin 7, Ireland
Status: Recruiting
Celgene Study Site
Dublin 8, Ireland
Status: Recruiting
Celgene Study Site
Bologna, Italy
Status: Recruiting
Celgene Study Site
Catania, Italy
Status: Recruiting
Celgene Study Site
San Giovanni Rotondo, Italy
Status: Recruiting
Celgene Study Site
Torino, Italy
Status: Recruiting
Celgene Study Site
Gdansk, Poland
Status: Recruiting
Celgene Study Site
Lodz, Poland
Status: Recruiting
Celgene Study Site
Ponce, Puerto Rico
Status: Recruiting
Celgene Study Site
Barcelona, Spain
Status: Recruiting
Celgene Study Site
Barcelona, Spain
Status: Recruiting
Celgene Study Site
Madrid, Spain
Status: Recruiting
Celgene Study Site
Boras, Sweden
Status: Recruiting
Celgene Study Site
Stockholm, Sweden
Status: Recruiting
Celgene Study Site
Ankara, Turkey
Status: Recruiting
Celgene Study Site
Ankara, Turkey
Status: Recruiting
Celgene Study Site
Canterbury Kent, United Kingdom
Status: Recruiting
Start Date
December 2012
Completion Date
October 2021
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page