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

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

Key facts

Study ID

NCT01734928

Run by

Celgene

People needed

559

Starts

2013-01-07

Expected to finish

2022-05-13

Last updated by the study team

2023-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be ≥ 18 years 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 may not qualify if…

• Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m\^2 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.

Where it is running

• Arizona Oncology — Tucson, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• University of California San Francisco Fresno Campus — Fresno, California, United States
• Marin Oncology Associates — Greenbrae, California, United States
• Moore UCSD Cancer Center — La Jolla, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Cancer Center of Central Connecticut — Southington, Connecticut, United States
• Local Institution - 153 — Southington, Connecticut, United States
• George Washington Medical Center — Washington D.C., District of Columbia, United States
• Lynn Cancer Institute — Boca Raton, Florida, United States
• University Cancer Institute — Boynton Beach, Florida, United States
• Broward Oncology Associates PA — Fort Lauderdale, Florida, United States
• Broward Oncology Assoc. — Fort Lauderdale, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Alves Domenech Oncology and Hematology Clinic — Hollywood, Florida, United States
• Palm Beach Cancer Institute, LLC — West Palm Beach, Florida, United States
• Local Institution - 135 — Marietta, Georgia, United States
• Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute — Marietta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Investigative Clinical Research of Indiana, LLC — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Southern Cancer Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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