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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

Description

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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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.

  • 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.

Sites

  • California

    • Celgene Study Site, Los Angeles, California, 90089
    • Celgene Study Site, La Jolla, California, 92093
    • Celgene Study Site, Santa Rosa, California, 95403
  • Arizona

    • Celgene Study Site, Tucson, Arizona, 85724
    • Celgene Study Site, Tucson, Arizona, 85710
  • Utah

    • Celgene Study Site, Salt Lake City, Utah, 84106
  • Colorado

    • Celgene Study Site, Aurora, Colorado, 80045
  • Washington

    • Celgene Study Site, Wenatchee, Washington, 98801
    • Celgene Study Site, Spokane, Washington, 99208
    • Celgene Study Site, Seattle, Washington, 98104
  • Montana

    • Celgene Study Site, Billings, Montana, 59102
  • Texas

    • Celgene Study Site, Fort Sam Houston, Texas, 78234
    • Celgene Study Site, Dallas, Texas, 75390
    • Celgene Study Site, Houston, Texas, 77090
  • Nebraska

    • Celgene Study Site, Lincoln, Nebraska, 68510
  • South Dakota

    • Celgene Study Site, Sioux Falls, South Dakota, 57105
    • Celgene Study Site, Watertown, South Dakota, 57201
  • Missouri

    • Celgene Study Site, Kansas City, Missouri, 64128
    • Celgene Study Site, Springfield, Missouri, 65807
    • Celgene Study Site, Jefferson City, Missouri, 65109
    • Celgene Study Site, St. Louis, Missouri, 63141
  • Iowa

    • Celgene Study Site, Iowa City, Iowa, 52242
  • Wisconsin

    • Celgene Study Site, Madison, Wisconsin, 53792
    • Celgene Study Site, Milwaukee, Wisconsin, 53226
  • Louisiana

    • Celgene Study Site, New Orleans, Louisiana, 70112
  • Kentucky

    • Celgene Study Site, Paducah, Kentucky, 42003
  • Tennessee

    • Celgene Study Site, Nashville, Tennessee, 37232
  • Indiana

    • Celgene Study Site, Indianapolis, Indiana, 46260
  • Michigan

    • Celgene Study Site, Grand Rapids, Michigan, 49503
    • Celgene Study Site, Lansing, Michigan, 48912
  • Georgia

    • Celgene Study Site, Marietta, Georgia, 30060
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