5392W-13: Celgene MM

CRC 13051: 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

Type of Study
Cancer (Oncology) - Multiple Myeloma
Swedish Cancer Institute
Short Description

Purpose: 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 or 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.

Open to Enrollment
Principal Investigator
Michael Milder, M.D.
Eligibility Notes
  • 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
  • No refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule
  • No peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization
  • No non-secretory multiple myeloma
  • No severe renal impairment requiring dialysis
  • No previous therapy with pomalidomide
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086