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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632826
Expanded Access Status : Approved for marketing
First Posted : July 3, 2012
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Pomalidomide

Detailed Description:
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.

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Study Type : Expanded Access
Official Title: 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



Intervention Details:
  • Drug: Pomalidomide
    4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632826


Locations
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United States, California
Celgene Study Site
Duarte, California, United States, 91010
Celgene Study Site
Greenbrae, California, United States, 94904
Celgene Study Site
Los Angeles, California, United States, 90048
United States, Colorado
Celgene Study Site
Denver, Colorado, United States, 80218
United States, Florida
Celgene Study Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Celgene Study Site
Marietta, Georgia, United States, 30060
United States, Illinois
Celgene Study Site
Peoria, Illinois, United States, 61615
United States, Indiana
Celgene Study Site
Indianapolis, Indiana, United States, 46202
United States, Iowa
Celgene Study Site
Iowa City, Iowa, United States, 52242
United States, Maryland
Celgene Study Site
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Celgene Study Site
Hyannis, Massachusetts, United States, 02601
United States, Missouri
Celgene Study Site
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Celgene Study Site
Omaha, Nebraska, United States, 68198
United States, New Jersey
Celgene Study Site
Hackensack, New Jersey, United States, 07601
United States, New York
Celgene Study Site
New York, New York, United States, 10016
Celgene Study Site
New York, New York, United States, 10029
United States, Pennsylvania
Celgene Study Site
Philadelphia, Pennsylvania, United States, 19107
Celgene Study Site
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Celgene Study Site
Greenville, South Carolina, United States, 29615
United States, South Dakota
Celgene Study Site
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Celgene Study Site
Dallas, Texas, United States, 75390
Celgene Study Site
Houston, Texas, United States, 77030
United States, Utah
Celgene Study Site
Salt Lake City, Utah, United States, 84106
United States, West Virginia
Celgene Study Site
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Celgene Study Site
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Celgene Study Site
Calgary, Alberta, Canada, T2N 4N2
Celgene Study Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Celgene Study Site
Vancouver, British Columbia, Canada, V5Z1M9
Celgene Study Site
Victoria, British Columbia, Canada, V8R6V5
Canada, Manitoba
Celgene Study Site
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Celgene Study Site
St. John's, Newfoundland and Labrador, Canada, A1B3V6
Canada, Nova Scotia
Celgene Study Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Celgene Study Site
Hamilton, Ontario, Canada, L8V 5C2
Celgene Study Site
London, Ontario, Canada, N6A 4G5
Celgene Study Site
Ottawa, Ontario, Canada, K1H 8L6
Celgene Study Site
Toronto, Ontario, Canada, M5G 2M9
Celgene Study Site
Windsor, Ontario, Canada, N8W1L9
Canada, Quebec
Celgene Study Site
Montreal, Quebec, Canada, H1T 2M4
Celgene Study Site
Montreal, Quebec, Canada, H3A 1A1
Celgene Study Site
Montreal, Quebec, Canada, H3T 1E2
Celgene Study Site
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Celgene Study Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Lars Sternas, MD, PhD Celgene Corporation
Publications:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01632826    
Other Study ID Numbers: CC-4047-MM-009
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Keywords provided by Celgene:
Relapsed
refractory multiple myeloma
pomalidomide
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Pomalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents