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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / IndustryCC-4047-MM-007
NCT01734928

Trial Description

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

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Celgene Corporation

Amine Bensmaine, MDStudy Director

Deborah IngenitoPh: 908-673-9581
  Email: dingenito@celgene.com

Trial Sites

U.S.A.
Arizona
  Tucson
 Celgene Study Site
California
  La Jolla
 Celgene Study Site
  Santa Rosa
 Celgene Study Site
Colorado
  Aurora
 Celgene Study Site
Connecticut
  Southington
 Celgene Study Site
District of Columbia
  Washington
 Celgene Study Site
Florida
  Boca Raton
 Celgene Study Site
  Boynton Beach
 Celgene Study Site
  Ft. Lauderdale
 Celgene Study Site
  West Palm Beach
 Celgene Study Site
Georgia
  Marietta
 Celgene Study Site
Indiana
  Indianapolis
 Celgene Study Site
Iowa
  Iowa City
 Celgene Study Site
Kentucky
  Paducah
 Celgene Study Site
Louisiana
  New Orleans
 Celgene Study Site
Maine
  Brewer
 Celgene Study Site
Maryland
  Baltimore
 Celgene Study Site
  Bethesda
 Celgene Study Site
Michigan
  Grand Rapids
 Celgene Study Site
  Lansing
 Celgene Study Site
Minnesota
  Duluth
 Celgene Study Site
Missouri
  Jefferson City
 Celgene Study Site
  Kansas City
 Celgene Study Site
  Springfield
 Celgene Study Site
  St. Louis
 Celgene Study Site
Montana
  Billings
 Celgene Study Site
Nebraska
  Lincoln
 Celgene Study Site
New Jersey
  Jersey City
 Celgene Study Site
  Morristown
 Celgene Study Site
  Somerville
 Celgene Study Site
New York
  New York
 Celgene Study Site
  Stony Brook
 Celgene Study Site
  Valhalla
 Celgene Study Site
North Carolina
  Greenville
 Celgene Study Site
Ohio
  Canton
 Celgene Study Site
  Toledo
 Celgene Study Site
South Carolina
  Charleston
 Celgene Study Site
South Dakota
  Sioux Falls
 Celgene Study Site
  Watertown
 Celgene Study Site
Tennessee
  Knoxville
 Celgene Study Site
  Nashville
 Celgene Study Site
Texas
  Dallas
 Celgene Study Site
  Fort Sam Houston
 Celgene Study Site
  Houston
 Celgene Study Site
Utah
  Salt Lake City
 Celgene Study Site
Washington
  Seattle
 Celgene Study Site
  Spokane
 Celgene Study Site
West Virginia
  Morgantown
 Celgene Study Site
Wisconsin
  Madison
 Celgene Study Site
  Milwaukee
 Celgene Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01734928
ClinicalTrials.gov processed this data on August 07, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.