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
Several clinical studies indicate that pomalidomide has activity in relapsed and refractory
multiple myeloma with response rates ranging between 30% and 60% at pomalidomide doses at 2
mg/day and/or 4 mg/day.
Drug: Pomalidomide
4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation
Inclusion Criteria:
1. Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and
have measurable disease (serum or urine M-protein)
2. Age ≥ 18 years
3. Must have had at least ≥ 2 prior anti-myeloma therapies
4. Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib,
either alone or in combination
5. Must have failed treatment with the last lenalidomide-containing regimen and the last
bortezomib-containing regimen
6. Must have documented disease progression during or after the last antimyeloma regimen
7. 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.
8. 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.
Exclusion Criteria:
1. Peripheral Neuropathy ≥ Grade 2
2. Non-secretory multiple myeloma
3. Previous therapy with pomalidomide
4. Use of any investigational agents within 28 days or 5 half lives (whichever is longer)
of initiating study treatment
5. Subjects with conditions requiring chronic steroid or immunosuppressive treatment.
6. Hypersensitivity to thalidomide, lenalidomide or dexamethasone
7. Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C
8. Pregnant or breastfeeding females
9. Unacceptable hematological or biochemical laboratory abnormalities
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
Saint 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
Celgene Study Site
Calgary, Alberta, Canada
Celgene Study Site
Edmonton, Alberta, Canada
Celgene Study Site
Vancouver, British Columbia, Canada
Celgene Study Site
Victoria, British Columbia, Canada
Celgene Study Site
Winnipeg, Manitoba, Canada
Celgene Study Site
St. John's, Newfoundland and Labrador, Canada
Celgene Study Site
Halifax, Nova Scotia, Canada
Celgene Study Site
Hamilton, Ontario, Canada
Celgene Study Site
London, Ontario, Canada
Celgene Study Site
Ottawa, Ontario, Canada
Celgene Study Site
Toronto, Ontario, Canada
Celgene Study Site
Windsor, Ontario, Canada
Celgene Study Site
Montreal, Quebec, Canada
Celgene Study Site
Montreal, Quebec, Canada
Celgene Study Site
Montreal, Quebec, Canada
Celgene Study Site
Quebec City, Quebec, Canada
Celgene Study Site
Saskatoon, Saskatchewan, Canada
Lars Sternas, MD, PhD, Study Director
Celgene Corporation