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

NCT ID: NCT00179647

Last Updated: 2010-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1913 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-04-30

Brief 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.

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide 5-25 mg, w/wo dexamethasone

single-arm, open-label, lenalidomide, 5-25 mg, 21/28 days, with/without dexamethasone

Group Type: OTHER

lenalidomide

Intervention Type: DRUG

Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone

dexamethasone

Intervention Type: DRUG

Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens

Interventions

lenalidomide

Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone

Intervention Type: DRUG

dexamethasone

Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens

Intervention Type: DRUG

Other Intervention Names

Revlimid; Decadron

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prologue Research International

INDUSTRY

Sponsor Role: collaborator

Celgene Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Celgene Corporation

Principal Investigators

Robert Knight, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Alta Bates Cancer Center

Berkeley, California, United States

Scripps Cancer Center

La Jolla, California, United States

Cedar Sinai Medical CenterDept of Medicine

Los Angeles, California, United States

Kaiser Permanente Medical Group

San Diego, California, United States

Stanford Cancer Center

Stanford, California, United States

Kaiser Permanente Medical Center

Vallejo, California, United States

University of ColoradoHealth Science Center

Aurora, Colorado, United States

Rocky Mountain Cancer Center-Midtown

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Hematology Oncology, PC

Stamford, Connecticut, United States

Delaware Clinical & Laboratory Physicians, PA

Newark, Delaware, United States

University of Miami Medical School

Miami, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Gulf Coast Oncology

St. Petersburg, Florida, United States

H Lee Moffitt Cancer Center

Tampa, Florida, United States

The Palm Beach Cancer Institute

West Palm Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University Med CtrDivision of Hem/Onc

Chicago, Illinois, United States

Rush Cancer Institute

Chicago, Illinois, United States

Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research Institute

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Wichita CCOP

Wichita, Kansas, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Maryland Medical Center Greenbaum Cancer Ctr

Baltimore, Maryland, United States

Center for Cancer And Blood Disorders

Bethesda, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Jackson Oncology Associates

Jackson, Mississippi, United States

Siteman Cancer Center

St Louis, Missouri, United States

Deaconess Billings Clinic

Billings, Montana, United States

Methodist Cancer Center

Omaha, Nebraska, United States

Nevada Cancer Center

Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center-Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

SUNY Health Science Center - Brooklyn

Brooklyn, New York, United States

North Shore Hematology/Oncology Associates, PC

East Setauket, New York, United States

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

NY Presbyterian Hospital/Weill Medical College-Cornell University

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

New York Medical Center, MBCCOP

The Bronx, New York, United States

Carolinas Hematology-Oncology Associates

Charlotte, North Carolina, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Dakota Cancer Institute

Fargo, North Dakota, United States

Mid Ohio Oncology & Hematology, Inc.

Columbus, Ohio, United States

Kaiser Permanente Northwest RegionCenter for Health Research

Portland, Oregon, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Charleston Hematology/Oncology P.A.

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

South Carolina Oncology Assoc

Columbia, South Carolina, United States

Avera Research Institute

Sioux Falls, South Dakota, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Intermountain Hematology/Oncology

Salt Lake City, Utah, United States

Medical College of Virginis, North Hospital

Richmond, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Gunderson Clinic

La Crosse, Wisconsin, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Oncology Alliance

Milwaukee, Wisconsin, United States

University of Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp

Vancouver, British Columbia, Canada

Dalhousie University Queen Elizabeth II Health Services Centre

Halifax, Nova Scotia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

McGill University

Montreal, Quebec, Canada

Countries

United States; Canada

References

Reece D, Song KW, Fu T, Roland B, Chang H, Horsman DE, Mansoor A, Chen C, Masih-Khan E, Trieu Y, Bruyere H, Stewart DA, Bahlis NJ. Influence of cytogenetics in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone: adverse effect of deletion 17p13. Blood. 2009 Jul 16;114(3):522-5. doi: 10.1182/blood-2008-12-193458. Epub 2009 Mar 30.

Reference Type: DERIVED

PMID: 19332768 (View on PubMed)

Other Identifiers

CC-5013-MM-016

Identifier Type: -

Identifier Source: org_study_id

NCT00331903

Identifier Type: -

Identifier Source: nct_alias