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

Description

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

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Drug: Pomalidomide

Specialties

  • Oncology: Myeloproliferative Dz,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials
  • Physician Assistant: Clinical Pharmacology,Hematology/Oncology

MeSH Terms

  • Multiple Myeloma
  • Plasma Cell

Study ID

Celgene Corporation -- CC-4047-MM-009

Status

Available

Trial ID

NCT01632826

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Celgene Corporation

Inclusion Criteria

    1. Histologically documented multiple myeloma 2. Age ? 18 years 3. Must have had at least ? 4 prior anti-myeloma therapies 4. Must have documented disease progression 5. 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 and for at least 28 days after study treatment discontinuation. 6. 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (25)

Study Location Distance Name Phone Email
Celgene Study Site - New York, New York 46.8 miles None None None
Celgene Study Site - Hackensack, New Jersey 47.6 miles None None None
Celgene Study Site - New York, New York 50.2 miles None None None
Celgene Study Site - Sellersville, Pennsylvania 122.9 miles None None None
Celgene Study Site - Philadelphia, Pennsylvania 133.3 miles None None None
Celgene Study Site - Hyannis, Massachusetts 156.5 miles None None None
Celgene Study Site - Baltimore, Maryland 223.1 miles None None None
Celgene Study Site - Morgantown, West Virginia 371.3 miles None None None
Celgene Study Site - Greenville, South Carolina 661.1 miles None None None
Celgene Study Site - Indianapolis, Indiana 686.4 miles None None None
Celgene Study Site - Milwaukee, Wisconsin 769.3 miles None None None
Celgene Study Site - Marietta, Georgia 797.5 miles None None None
Celgene Study Site - Peoria, Illinois 855.5 miles None None None
Celgene Study Site - St. Louis, Missouri 919.8 miles None None None
Celgene Study Site - Iowa City, Iowa 948.5 miles None None None
Celgene Study Site - West Palm Beach, Florida 1,077.8 miles None None None
Celgene Study Site - Omaha, Nebraska 1,182.2 miles None None None
Celgene Study Site - Sioux Falls, South Dakota 1,208.2 miles None None None
Celgene Study Site - Dallas, Texas 1,414.8 miles None None None
Celgene Study Site - Houston, Texas 1,475.7 miles None None None
Celgene Study Site - Denver, Colorado 1,665.3 miles None None None
Celgene Study Site - Salt Lake City, Utah 2,003.0 miles None None None
Celgene Study Site - Duarte, California 2,472.0 miles None None None
Celgene Study Site - Los Angeles, California 2,495.4 miles None None None
Celgene Study Site - Greenbrae, California 2,605.9 miles None None None

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