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For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline.
Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter.
Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CC-5013 - oral - 30mg daily on days 1-21 every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-5013 | Drug | CC-5013 - oral - 30mg daily on days 1-21 every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myeloma response | randomization to progression |
| Measure | Description | Time Frame |
|---|---|---|
| Time to tumor progression | randomization to progression | |
| Duration of response | randomization to progression | |
| Survival (1-year and overall survival) |
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Inclusion Criteria:
Exclusion Criteria:
A) Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L) B) Platelet count <75,000/mm^3 (75 x 10^9/L) C) Serum creatinine >2.5 mg/dL (221 umol/L) D) Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) E) Serum total bilirubin >2.0 mg/dL (34 umol/L)
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knight, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Verde Hematology Oncology | Glendale | Arizona | 85304 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19471019 | Background | Richardson P, Jagannath S, Hussein M, Berenson J, Singhal S, Irwin D, Williams SF, Bensinger W, Badros AZ, Vescio R, Kenvin L, Yu Z, Olesnyckyj M, Zeldis J, Knight R, Anderson KC. Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma. Blood. 2009 Jul 23;114(4):772-8. doi: 10.1182/blood-2008-12-196238. Epub 2009 May 26. |
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| 1 year and ongoing |
| Time to first skeletal-related event (SRE) (clinical need for radiation or surgery to bone) | randomization to progression |
| Safety (type, frequency, severity, and relationship of adverse events to study drug) | ongoing |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Alta Bates Comprehensive Cancer Center | Berkeley | California | 94704 | United States |
| Providence St. Joseph Medical Center/Cancer Center | Burbank | California | 91505 | United States |
| Wilshire Oncology Medical Group, Inc. | La Verne | California | 91750 | United States |
| Institute for Myeloma and Bone | Los Angeles | California | 90067 | United States |
| Cancer Care Associates | Redondo Beach | California | 90277 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Northwest Georgia Oncology Centers | Marietta | Georgia | 30060 | United States |
| Atlanta Cancer Care-Roswell | Roswell | Georgia | 30076 | United States |
| Northwestern University Med Ctr | Chicago | Illinois | 60611-2927 | United States |
| Midwest Cancer Research Group | Skokie | Illinois | 60077 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201-1595 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20717 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Nevada Cancer Center | Las Vegas | Nevada | 89109 | United States |
| SUNY Health Science Center at Brooklyn | Brooklyn | New York | 11203 | United States |
| St. Vincent's Comprehensive Cancer Center | New York | New York | 10011 | United States |
| Carolina Hematology-Oncology Associates | Charlotte | North Carolina | 28203 | United States |
| Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35 | Cleveland | Ohio | 44195 | United States |
| Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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