Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

APPROVED_FOR_MARKETING

Conditions studied: Multiple Myeloma

In brief

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

Key facts

Study ID

NCT01632826

Run by

Celgene

Last updated by the study team

2019-11-12

Who can join

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

You may qualify if…

• Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine M-protein)
• Age ≥ 18 years
• Must have had at least ≥ 2 prior anti-myeloma therapies
• Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination
• Must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen
• Must have documented disease progression during or after the last antimyeloma regimen
• Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting drug, while participating in the study and for at least 28 days after study treatment discontinuation.
• Males must agree to use a latex condom during sexual contact with FCBP while participating in the study and for 28 days following discontinuation from study treatment.

You may not qualify if…

• Peripheral Neuropathy ≥ Grade 2
• Non-secretory multiple myeloma
• Previous therapy with pomalidomide
• Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment
• Subjects with conditions requiring chronic steroid or immunosuppressive treatment.
• Hypersensitivity to thalidomide, lenalidomide or dexamethasone
• Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C
• Pregnant or breastfeeding females
• Unacceptable hematological or biochemical laboratory abnormalities

Where it is running

• Celgene Study Site — Duarte, California, United States
• Celgene Study Site — Greenbrae, California, United States
• Celgene Study Site — Los Angeles, California, United States
• Celgene Study Site — Denver, Colorado, United States
• Celgene Study Site — West Palm Beach, Florida, United States
• Celgene Study Site — Marietta, Georgia, United States
• Celgene Study Site — Peoria, Illinois, United States
• Celgene Study Site — Indianapolis, Indiana, United States
• Celgene Study Site — Iowa City, Iowa, United States
• Celgene Study Site — Baltimore, Maryland, United States
• Celgene Study Site — Hyannis, Massachusetts, United States
• Celgene Study Site — St Louis, Missouri, United States
• Celgene Study Site — Omaha, Nebraska, United States
• Celgene Study Site — Hackensack, New Jersey, United States
• Celgene Study Site — New York, New York, United States
• Celgene Study Site — New York, New York, United States
• Celgene Study Site — Philadelphia, Pennsylvania, United States
• Celgene Study Site — Sellersville, Pennsylvania, United States
• Celgene Study Site — Greenville, South Carolina, United States
• Celgene Study Site — Sioux Falls, South Dakota, United States
• Celgene Study Site — Dallas, Texas, United States
• Celgene Study Site — Houston, Texas, United States
• Celgene Study Site — Salt Lake City, Utah, United States
• Celgene Study Site — Morgantown, West Virginia, United States
• Celgene Study Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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