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Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: lenalidomide (Drug); dexamethasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Robert Knight, MD, Study Director, Affiliation: Celgene Corporation

Summary

Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for the indication of multiple myeloma.

Clinical Details

Official title: A Multicenter, Single-Arm, Open-Label, Expanded Access Program for Lenalidomide With or Without Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.

Overall Incidence of Adverse Events

Detailed description: This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Subjects had the following options for dexamethasone treatment at the discretion of the treating physician: Option A: No dexamethasone. Option B: Oral pulse dexamethasone administered at a dose of 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle. Option C: Oral pulse dexamethasone administered at a dose of 20 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle. Option D: Oral dexamethasone administered at a dose of 40 mg weekly on Days 1, 8, 15, and 22 for each 28-day cycle for all cycles. Treatment was to be continued as tolerated until disease progression developed. Doses of lenalidomide were allowed to be reduced first from 25 mg to 15 mg and then in 5-mg decrements due to lenalidomide toxicity. Subjects who could not tolerate a daily dose of 5 mg for 21 days every 28 days were discontinued from treatment. At the discretion of the investigator, doses of dexamethasone were modified due to dexamethasone toxicity. Dose reduction and discontinuation schemes for dexamethasone varied according to the treatment option administered. Study visits occurred every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression was documented, study drug was discontinued for another reason, or lenalidomide became commercially available for this indication.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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. 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. 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 glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [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.

Locations and Contacts

University of Calgary, Calgary, Alberta 2N 4N1, Canada

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Mayo Clinic, Scottsdale, Arizona 85259, United States

Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp, Vancouver, British Columbia V5Z 4E3, Canada

Alta Bates Cancer Center, Berkeley, California 94704, United States

Scripps Cancer Center, La Jolla, California 93037, United States

Cedar Sinai Medical CenterDept of Medicine, Los Angeles, California 90048, United States

Kaiser Permanente Medical Group, San Diego, California 32120, United States

Stanford Cancer Center, Stanford, California 94305-5750, United States

Kaiser Permanente Medical Center, Vallejo, California 94589, United States

University of ColoradoHealth Science Center, Aurora, Colorado 80045-0510, United States

Rocky Mountain Cancer Center-Midtown, Denver, Colorado 80218, United States

Yale University School of Medicine, New Haven, Connecticut 06520, United States

Hematology Oncology, PC, Stamford, Connecticut 06902, United States

Delaware Clinical & Laboratory Physicians, PA, Newark, Delaware 19713, United States

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida 33140, United States

University of Miami Medical School, Miami, Florida 33136, United States

Gulf Coast Oncology, St. Petersburg, Florida 33705, United States

H Lee Moffitt Cancer Center, Tampa, Florida 33612-9497, United States

The Palm Beach Cancer Institute, West Palm Beach, Florida 33401, United States

Emory University, Atlanta, Georgia 30322, United States

Northwestern University Med CtrDivision of Hem/Onc, Chicago, Illinois 60611-2927, United States

Rush Cancer Institute, Chicago, Illinois 60612-3824, United States

Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research Institute, Indianapolis, Indiana 46202-5254, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7233, United States

Wichita CCOP, Wichita, Kansas 67214, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

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

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Jackson Oncology Associates, Jackson, Mississippi 39202, United States

Siteman Cancer Center, St. Louis, Missouri 63110, United States

Deaconess Billings Clinic, Billings, Montana 59102, United States

Methodist Cancer Center, Omaha, Nebraska 68114, United States

Nevada Cancer Center, Las Vegas, Nevada 89109, United States

Dartmouth Hitchcock Medical Center-Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States

The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

New York Medical Center, MBCCOP, Bronx, New York 10466, United States

SUNY Health Science Center - Brooklyn, Brooklyn, New York 11203, United States

North Shore Hematology/Oncology Associates, PC, East Setauket, New York 11733, United States

NY Presbyterian Hospital/Weill Medical College-Cornell University, New York, New York 10021, United States

St. Vincent's Comprehensive Cancer Center, New York, New York 10011, United States

SUNY Upstate Medical University, Syracuse, New York 13210, United States

Carolinas Hematology-Oncology Associates, Charlotte, North Carolina 28203, United States

Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1023, United States

Dakota Cancer Institute, Fargo, North Dakota 58108-6001, United States

Dalhousie University Queen Elizabeth II Health Services Centre, Halifax, Nova Scotia B3H2Y9, Canada

Mid Ohio Oncology & Hematology, Inc., Columbus, Ohio 43215, United States

Princess Margaret Hospital, Toronto, Ontario M5J 2M9, Canada

Kaiser Permanente Northwest RegionCenter for Health Research, Portland, Oregon 97227, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15232, United States

Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania 15224, United States

McGill University, Montreal, Quebec H2W 1S6, Canada

Charleston Hematology/Oncology P.A., Charleston, South Carolina 29403, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

South Carolina Oncology Assoc, Columbia, South Carolina 29210, United States

Avera Research Institute, Sioux Falls, South Dakota 57105, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390-9016, United States

MD Anderson Cancer Center, Houston, Texas 77030, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84112, United States

Intermountain Hematology/Oncology, Salt Lake City, Utah 84124, United States

Medical College of Virginis, North Hospital, Richmond, Virginia 23298, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Gunderson Clinic, LaCrosse, Wisconsin 54601, United States

Marshfield Clinic, Marshfield, Wisconsin 54449, United States

Oncology Alliance, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: September 2005
Last updated: March 10, 2010

Page last updated: August 23, 2015

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