An Expanded Access Program For Lenalidomide Plus Dexamethasone In Previously Treated Subjects With Multiple Myeloma

Condition(s) targeted: Multiple Myeloma

Intervention: lenalidomide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Celgene Corporation

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 for multiple myeloma.

Official title: A Multicenter, Single-Arm Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: To provide lenalidomide to subjects with a high likelihood of benefit.

Secondary outcome: To obtain additional safety data.

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 (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.

University of Calgary, Calgary, Alberta 2N 4N1, Canada; Recruiting
Nizar Bahlis, Dr., Phone: 403-944-1564, Email: nbahlis@ucalgary.ca
Nizar Bahlis, Dr., Principal Investigator

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada; Recruiting
Tony Reiman, MD, Phone: 780-432-8757, Email: tonyreim@cacnerboard.ab.ca
Joanne Hewitt, Phone: 780-432-8791, Email: joannehe@cancerboard.ab.ca
Tony Reiman, MD, Principal Investigator

Mayo Clinic, Scottsdale, Arizona 85259, United States; Completed

Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp, Vancouver, British Columbia V5Z 4E3, Canada; Recruiting
Kevin Song, Dr., Phone: 608-875-4863, Email: ksong@bccancer.bc.ca
Kevin Song, Dr., Principal Investigator

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Emory University, Atlanta, Georgia 30322, United States; Completed

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

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

Indiana Univ Cancer CenterBone Marrow Transplantation ProgramIndiana Cancer Research Institute, Indianapolis, Indiana 46202-5254, United States; Completed

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

Wichita CCOP, Wichita, Kansas 67214, United States; Completed

University of Louisville, Louisville, Kentucky 40202, United States; Completed

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

Maine Center for Cancer Medicine/Blood Disorders, Scarborough, Maine 04074, United States; Completed

University of Maryland Medical Center Greenbaum Cancer Ctr, Baltimore, Maryland 21201-1595, United States; Completed

Center for Cancer And Blood Disorders, Bethesda, Maryland 20817, United States; Completed

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

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

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

Deaconess Billings Clinic, Billings, Montana 59102, United States; Completed

Methodist Cancer Center, Omaha, Nebraska 68114, United States; Completed

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

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

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

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

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

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

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

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

University of Rochester Medical Center, Rochester, New York 14642, United States; Completed

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

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

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

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

Dalhousie UniversityQueen Elizabeth II Health Services Centre, Halifax, Nova Scotia B3H2Y9, Canada; Recruiting
Darrell White, MD, Phone: 902-473-4642, Email: Susan.Pleasance@cdha.nshealth.ca
Susan Pleasance, Phone: 902-473-7585, Email: Susan.Pleasance@cdha.nshealth.ca
Darrell White, Dr., Principal Investigator

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

Princess Margaret Hospital, Toronto, Ontario M5J 2M9, Canada; Recruiting
Christine Chen, MD, Phone: 416-946-2824, Email: christine.chen@uhn.on.ca
Esther Masih-Khan, PhD, Phone: 416-946-4576, Email: esther.masih-khan@uhn.on.ca
Christine Chen, MD, Principal Investigator

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

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

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

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

McGill University, Montreal, Quebec H2W 1S6, Canada; Recruiting
Chaim Shustik, Dr., Phone: 514-842-1231, ext. 31558, Email: ShustikC@muhchem.mcgill.ca
Chaim Shustik, Dr., Principal Investigator

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

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

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

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

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

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

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

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

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

Swedish Cancer Institute, Seattle, Washington 98104, United States; Completed

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

Gunderson Clinic, LaCrosse, Wisconsin 54601, United States; Completed

Marshfield Clinic, Marshfield, Wisconsin 54449, United States; Completed

Oncology Alliance, Milwaukee, Wisconsin 53215, United States; Completed

Starting date: September 2005
Ending date: September 2008
Last updated: January 29, 2008