Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

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

Official Title

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

Keywords

Multiple Myeloma Pomalidomide Neoplasms, Plasma Cell Dexamethasone acetate Dexamethasone Bortezomib Thalidomide BB 1101

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • Moore UCSD Cancer Center
    La Jolla California 92083 United States
  • USC Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT01734928
Phase
Phase 3
Study Type
Interventional
Last Updated
May 30, 2018