Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, MM, Revlimid, CC5013, celgene, cc-5013, relapsed/refractory, lenalidomide, dexamethasone, Decadron
Eligibility Criteria
Inclusion Criteria: Must understand and voluntarily sign an informed consent form. Must be > or = to 18 years of age at the time of signing the informed consent form. Must be able to adhere to the study visit schedule and other protocol requirements. 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. 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. Measurable levels of myeloma paraprotein in serum (>/=0.5 g/dL) or urine (>/=0.2 g excreted in a 24-hour collection sample). Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 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: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or lactating females. 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. Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L) Platelet count <75,000/mm3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells. Platelet count <30,000/mm3 (30x109/L) for subjects in whom >/= 50% of bone marrow nucleated cells are plasma cells. Serum creatinine >2.5 mg/dL (221 mmol/L) Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT]) >3.0 x upper limit of normal (ULN) Serum total bilirubin >2.0 mg/dL (34 mmol/L) 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. Known hypersensitivity to thalidomide or dexamethasone. Prior history of uncontrollable side effects to dexamethasone therapy. The development of a desquamating rash while taking thalidomide. 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.
Sites / Locations
- Mayo Clinic
- Alta Bates Cancer Center
- Scripps Cancer Center
- Cedar Sinai Medical CenterDept of Medicine
- Kaiser Permanente Medical Group
- Stanford Cancer Center
- Kaiser Permanente Medical Center
- University of ColoradoHealth Science Center
- Rocky Mountain Cancer Center-Midtown
- Yale University School of Medicine
- Hematology Oncology, PC
- Delaware Clinical & Laboratory Physicians, PA
- Mount Sinai Comprehensive Cancer Center
- University of Miami Medical School
- Gulf Coast Oncology
- H Lee Moffitt Cancer Center
- The Palm Beach Cancer Institute
- Emory University
- Northwestern University Med CtrDivision of Hem/Onc
- Rush Cancer Institute
- Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research Institute
- University of Kansas Medical Center
- Wichita CCOP
- Ochsner Clinic Foundation
- University of Maryland Medical Center Greenbaum Cancer Ctr
- Center for Cancer And Blood Disorders
- Dana-Farber Cancer Institute
- Mayo Clinic Cancer Center
- Jackson Oncology Associates
- Siteman Cancer Center
- Deaconess Billings Clinic
- Methodist Cancer Center
- Nevada Cancer Center
- Dartmouth Hitchcock Medical Center-Norris Cotton Cancer Center
- The Cancer Center at Hackensack University Medical Center
- New York Medical Center, MBCCOP
- SUNY Health Science Center - Brooklyn
- North Shore Hematology/Oncology Associates, PC
- St. Vincent's Comprehensive Cancer Center
- NY Presbyterian Hospital/Weill Medical College-Cornell University
- SUNY Upstate Medical University
- Carolinas Hematology-Oncology Associates
- Wake Forest University School of Medicine
- Dakota Cancer Institute
- Mid Ohio Oncology & Hematology, Inc.
- Kaiser Permanente Northwest RegionCenter for Health Research
- University of Pennsylvania Cancer Center
- Western Pennsylvania Cancer Institute
- University of Pittsburgh Medical Center
- Charleston Hematology/Oncology P.A.
- Medical University of South Carolina
- South Carolina Oncology Assoc
- Avera Research Institute
- University of Texas Southwestern Medical Center
- MD Anderson Cancer Center
- Huntsman Cancer Institute
- Intermountain Hematology/Oncology
- Medical College of Virginis, North Hospital
- Swedish Cancer Institute
- Fred Hutchinson Cancer Research Center
- Gunderson Clinic
- Marshfield Clinic
- Oncology Alliance
- University of Calgary
- Cross Cancer Institute
- Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
- Dalhousie University Queen Elizabeth II Health Services Centre
- Princess Margaret Hospital
- McGill University
Arms of the Study
Arm 1
Other
Lenalidomide 5-25 mg, w/wo dexamethasone
single-arm, open-label, lenalidomide, 5-25 mg, 21/28 days, with/without dexamethasone