Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Basic Trial Information
|Phase III||Treatment||18 and over||CC-4047-MM-007|
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
All subjects must have received prior treatment with a lenalidomide containing
regimen for at least 2 consecutive cycles.
Must have documented disease progression during or after their last anti-myeloma
Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
Must have documented diagnosis of multiple myeloma and have measureable disease by
serum and urine protein electrophoresis.
Must be ≥ 18yrs at the time of signing informed consent.
Previous therapy with pomalidomide.
Subjects with severe renal impairment requiring dialysis.
Non-secretory multiple myeloma.
Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to
Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice
weekly dosing schedule.
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
USC / Norris Comprehensive Cancer Center
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Clayton Allan Smith
Beth Israel Deaconess Medical Center
Jacalyn M. Rosenblatt
Jacalyn M. Rosenblatt
Dana-Farber Cancer Institute
Paul Gerard Guy Richardson
Massachusetts General Hospital
Albert Einstein College of Medicine
Medical University of South Carolina
Luciano Jose Megale Costa
Vanderbilt University/Ingram Cancer Center
Madan Harikishin Jagasia
UT Southwestern/Simmons Cancer Center-Dallas
Larry D. Anderson
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01734928
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.