Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
PEXIUS
A Multicenter, Single-Arm, Open-Label Treatment Use Protocol for Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
1 other identifier
expanded_access
N/A
2 countries
42
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 3, 2012
CompletedNovember 12, 2019
November 1, 2019
June 29, 2012
November 7, 2019
Conditions
Keywords
Interventions
4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (42)
Celgene Study Site
Duarte, California, 91010, United States
Celgene Study Site
Greenbrae, California, 94904, United States
Celgene Study Site
Los Angeles, California, 90048, United States
Celgene Study Site
Denver, Colorado, 80218, United States
Celgene Study Site
West Palm Beach, Florida, 33401, United States
Celgene Study Site
Marietta, Georgia, 30060, United States
Celgene Study Site
Peoria, Illinois, 61615, United States
Celgene Study Site
Indianapolis, Indiana, 46202, United States
Celgene Study Site
Iowa City, Iowa, 52242, United States
Celgene Study Site
Baltimore, Maryland, 21215, United States
Celgene Study Site
Hyannis, Massachusetts, 02601, United States
Celgene Study Site
St Louis, Missouri, 63110, United States
Celgene Study Site
Omaha, Nebraska, 68198, United States
Celgene Study Site
Hackensack, New Jersey, 07601, United States
Celgene Study Site
New York, New York, 10016, United States
Celgene Study Site
New York, New York, 10029, United States
Celgene Study Site
Philadelphia, Pennsylvania, 19107, United States
Celgene Study Site
Sellersville, Pennsylvania, 18960, United States
Celgene Study Site
Greenville, South Carolina, 29615, United States
Celgene Study Site
Sioux Falls, South Dakota, 57105, United States
Celgene Study Site
Dallas, Texas, 75390, United States
Celgene Study Site
Houston, Texas, 77030, United States
Celgene Study Site
Salt Lake City, Utah, 84106, United States
Celgene Study Site
Morgantown, West Virginia, 26506, United States
Celgene Study Site
Milwaukee, Wisconsin, 53226, United States
Celgene Study Site
Calgary, Alberta, T2N 4N2, Canada
Celgene Study Site
Edmonton, Alberta, T6G 1Z2, Canada
Celgene Study Site
Vancouver, British Columbia, V5Z1M9, Canada
Celgene Study Site
Victoria, British Columbia, V8R6V5, Canada
Celgene Study Site
Winnipeg, Manitoba, R3E 0V9, Canada
Celgene Study Site
St. John's, Newfoundland and Labrador, A1B3V6, Canada
Celgene Study Site
Halifax, Nova Scotia, B3H 1V7, Canada
Celgene Study Site
Hamilton, Ontario, L8V 5C2, Canada
Celgene Study Site
London, Ontario, N6A 4G5, Canada
Celgene Study Site
Ottawa, Ontario, K1H 8L6, Canada
Celgene Study Site
Toronto, Ontario, M5G 2M9, Canada
Celgene Study Site
Windsor, Ontario, N8W1L9, Canada
Celgene Study Site
Montreal, Quebec, H1T 2M4, Canada
Celgene Study Site
Montreal, Quebec, H3A 1A1, Canada
Celgene Study Site
Montreal, Quebec, H3T 1E2, Canada
Celgene Study Site
Québec, Quebec, G1R 2J6, Canada
Celgene Study Site
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (1)
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.
PMID: 30068263BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars Sternas, MD, PhD
Celgene Corporation