Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT01632826
Last Updated: 2019-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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Pomalidomide
4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Sternas, MD, PhD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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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
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
Québec, Quebec, Canada
Celgene Study Site
Saskatoon, Saskatchewan, Canada
Countries
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References
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Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.
Other Identifiers
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CC-4047-MM-009
Identifier Type: -
Identifier Source: org_study_id
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