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16M-13-2 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

Multiple myeloma (MM) is a rare and incurable progressive neoplastic disease that accounts for 10% of all hematological malignancies. the disease follows a relapsing course in the majority of patients, regardless of treatment regimen or initial response totreatment. MM remains incurable using conventional treatments, with median survival duration of approximately 5 years. Therefore, there is a need for more effective therapeutic options for the treatment of relapsed or refractory multiple myeloma. The main considerations for choosing an appropriate treatment for relapsed MM are: risk level, prior therapy, duration of response to prior therapy, residual toxicity, age, physical condition, and whether or not the patient is a candidate for allogeneic stem cell transplantation. Preclinical studies have shown that both thalidomide and lenalidomide potentiate the activity of bortezomib in combination of dexamethasone. This is a multicenter, randomized, open-label study. The principal objective of this study is to compare the efficacy of pomalidomide + bortezomib + low-dose dexamethasone with bortezomib + low-dose dexamethasone in study participants with relapsed or refractory MM. Study participants will be randomized in a 1:1 ratio to Treatment Arm A or B, respectively (Treatment Arm A: (POM + BTZ + LD-DEX) / Treatment Arm B: (BTZ + LD-DEX). All long-term follow-up phase participants will be contacted four (4) times a year (every 3 months) to obtain survival status for at least 5 years after randomization or longer if clinically indicated. PFS will be compared between treatment arms using a log-rank test stratified by the threebaseline factors used in the randomization. The Kaplan-Meier method will be used to estimate the survival distribution functions for each treatment arm. One interim analysis is planned when approximately 50% of the PFS information is reached, i.e., 254 out of the total of 508 PFS events required for the final PFS analysis.

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 ≥ 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.

  • 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.

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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