subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available

Condition	Intervention	Phase
Multiple Myeloma	Drug: CC-5013  Drug: Dexamethasone	Phase IV

Further Study Details: 

Primary Outcomes: To provide lenalidomide to subjects with a high likelihood of benefit.
Secondary Outcomes: To obtain additional safety data.
Expected Total Enrollment:  12000

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Must understand and voluntarily sign an informed consent form.
2. Must be > or = to 18 years of age at the time of signing the informed consent form.
3. Must be able to adhere to the study visit schedule and other protocol requirements.
4. Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment (see Appendix 21.4).
5. Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.
6. Measurable levels of myeloma paraprotein in serum (>/=0.5 g/dL) or urine (>/=0.2 g excreted in a 24-hour collection sample).
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Appendix 21.3).
8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study medication.

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or lactating females.
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

4. Any of the following laboratory abnormalities:

   1. Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L)
   2. Platelet count <75,000/mm3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
   3. Platelet count <30,000/mm3 (30x109/L) for subjects in whom >/= 50% of bone marrow nucleated cells are plasma cells.
   4. Serum creatinine >2.5 mg/dL (221 mmol/L)
   5. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
   6. Serum total bilirubin >2.0 mg/dL (34 mmol/L)
5. Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >/= 1 year.
6. Known hypersensitivity to thalidomide or dexamethasone.
7. Prior history of uncontrollable side effects to dexamethasone therapy.
8. The development of a desquamating rash while taking thalidomide.
9. Use of any standard/experimental anti-myeloma drug therapy within 28 days of the initiation of study drug treatment or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of the initiation of study drug treatment.

Please refer to this study by ClinicalTrials.gov identifier  NCT00179647

Arizona
      Mayo Clinic, Scottsdale,  Arizona,  85259,  United States
California
      Cedar Sinai Medical Center Dept of Medicine, Los Angeles,  California,  90048,  United States
      UCSF California, San Francisco,  California,  94143,  United States
      Alta Bates Cancer Center, Berkeley,  California,  94704,  United States
      Kaiser Permanente Medical Group, San Diego,  California,  32120,  United States
      Stanford Cancer Center, Stanford,  California,  94305-5750,  United States
      Comprehensive Cancer Centers of the Desert, Palm Springs,  California,  92262,  United States
      Scripps Cancer Center, La Jolla,  California,  93037,  United States
Colorado
      Rocky Mountain Cancer Center-Midtown, Denver,  Colorado,  80218,  United States
      University of Colorado Health Science Center, Aurora,  Colorado,  80045-0510,  United States
Connecticut
      Yale University School of Medicine, New Haven,  Connecticut,  06520,  United States
Florida
      H Lee Moffitt Cancer Center, Tampa,  Florida,  33612-9497,  United States
      Mount Sinai Comprehensive Cancer Center, Miami Beach,  Florida,  33140,  United States
Georgia
      Emory University, Atlanta,  Georgia,  30322,  United States
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      Northwestern University Med Ctr Division of Hem/Onc, Chicago,  Illinois,  60611-2927,  United States
      Rush Cancer Institute, Chicago,  Illinois,  60612-3824,  United States
Indiana
      Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research Institute, Indianapolis,  Indiana,  46202-5254,  United States
Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7233,  United States
      Wichita CCOP, Wichita,  Kansas,  67214,  United States
Louisiana
      Ochsner Clinical Foundation, New Orleans,  Louisiana,  70121,  United States
Maryland
      University of Maryland Medical Center Greenbaum Cancer Ctr, Baltimore,  Maryland,  21201-1595,  United States
      Center for Cancer And Blood Disorders, Bethesda,  Maryland,  20817,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Missouri
      Siteman Cancer Center, St. Louis,  Missouri,  63110,  United States
Nevada
      Nevada Cancer Center, Las Vegas,  Nevada,  89109,  United States
New Jersey
      The Cancer Center at Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States
New York
      NY Presbyterian Hospital/Weill Medical College-Cornell University, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute Dept of Medicine, Buffalo,  New York,  14263,  United States
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States
      St. Vincent''''s Comprehensive Cancer Center, New York,  New York,  10011,  United States
      New York Medical Center, MBCCOP, Bronx,  New York,  10466,  United States
North Carolina
      Carolinas Hematology-Oncology Associates, Charlotte,  North Carolina,  28203,  United States
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157-1023,  United States
North Dakota
      Dakota Cancer Institute, Fargo,  North Dakota,  58108-6001,  United States
Oklahoma
      University of Oklahoma, Oklahoma City,  Oklahoma,  73104,  United States
Oregon
      Kaiser Permanente Northwest Region Center for Health Research, Portland,  Oregon,  97227,  United States
Pennsylvania
      University of Pittsburgh VA Pittsburgh Health Care System, Pittsburgh,  Pennsylvania,  15240,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
South Carolina
      Charleston Hematology/Oncology P.A., Charleston,  South Carolina,  29403,  United States
      South Carolina Oncology Assoc, Columbia,  South Carolina,  29210,  United States
South Dakota
      Avera Research Institute, Sioux Falls,  South Dakota,  57105,  United States
Tennessee
      The Vanderbilt Clinic, Nashville,  Tennessee,  37232,  United States
Texas
      University of Texas Southwestern Medical Center, Dallas,  Texas,  75390-9016,  United States
      MD Anderson Cancer Center, Houston,  Texas,  77030,  United States
      UT-Health Sciences Center of San Antonio, San Antonio,  Texas,  78229,  United States
Utah
      Intermountain Hematology/Oncology, Salt Lake City,  Utah,  84124,  United States
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States
Washington
      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States
Wisconsin
      Gunderson Clinic, LaCrosse,  Wisconsin,  54601,  United States
      Marshfield Clinic, Marshfield,  Wisconsin,  54449,  United States
      Oncology Alliance, Milwaukee,  Wisconsin,  53215,  United States
Canada, Alberta
      University of Calgary, Calgary,  Alberta,  2N 4N1,  Canada
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, British Columbia
      Leukemia/BMT Program of BC Div of Hem, Vancouver Gen Hosp, Vancouver,  British Columbia,  V5Z 4E3,  Canada
Canada, Nova Scotia
      Dalhousie University Queen Elizabeth II Health Services Centre, Halifax,  Nova Scotia,  B3H2Y9,  Canada
Canada, Ontario
      Princess Margaret Hospital, Toronto,  Ontario,  M5J 2M9,  Canada
Canada, Quebec
      McGill University, Montreal,  Quebec,  H2W 1S6,  Canada

Study ID Numbers:  CC-5013-MM--016
Last Updated:  September 15, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00179647
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20