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|
TRIAL STATUS: Active
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
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
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
Non-secretory multiple myeloma.
Subjects with severe renal impairment requiring dialysis.
Previous therapy with pomalidomide.
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
USC / Norris Comprehensive Cancer Center
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Clayton Allan Smith
University of Chicago Comprehensive Cancer Center
Andrzej J. Jakubowiak
Beth Israel Deaconess Medical Center
Jacalyn M. Rosenblatt
Jacalyn M. Rosenblatt
Dana-Farber/Harvard Cancer Center
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 Identifier 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.