Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Phase: Phase 3
Diagnosis: Multiple Myeloma
NCT ID: NCT01734928
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:
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
Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital
Jacalyn Rosenblatt, MD,
Beth Israel Deaconess Medical Center
Paul Richardson, MD,
Dana-Farber Cancer Institute
Andrew Yee, MD,
Massachusetts General Hospital
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute:
Deborah Doss, 617-632-5672,
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- 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.