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Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Status: Recruiting
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

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Jacalyn Rosenblatt, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Paul Richardson, MD, Dana-Farber Cancer Institute
Andrew Yee, MD, Massachusetts General Hospital

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Deborah Doss, 617-632-5672, ddoss@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - 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. Exclusion Criteria: - 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.
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