Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
A Multicenter, Single-Arm, Open-Label, Expanded Access Program for Lenalidomide With or Without Dexamethasone in Previously Treated Subjects With Multiple Myeloma
1 other identifier
interventional
1,913
2 countries
69
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Sep 2005
Shorter than P25 for phase_3 multiple-myeloma
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
March 3, 2010
CompletedMarch 16, 2010
March 1, 2010
3.3 years
September 13, 2005
December 21, 2009
March 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.
Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Median time-on-study=18.3 weeks
Overall Incidence of Adverse Events
Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Median time-on-study=18.3 weeks
Study Arms (1)
Lenalidomide 5-25 mg, w/wo dexamethasone
OTHERsingle-arm, open-label, lenalidomide, 5-25 mg, 21/28 days, with/without dexamethasone
Interventions
Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone
Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgene Corporationlead
- Prologue Research Internationalcollaborator
Study Sites (69)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
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
University of Miami Medical School
Miami, Florida, 33136, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, 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
SUNY Health Science Center - Brooklyn
Brooklyn, New York, 11203, United States
North Shore Hematology/Oncology Associates, PC
East Setauket, New York, 11733, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
NY Presbyterian Hospital/Weill Medical College-Cornell University
New York, New York, 10021, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
New York Medical Center, MBCCOP
The Bronx, New York, 10466, 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
Mid Ohio Oncology & Hematology, Inc.
Columbus, Ohio, 43215, United States
Kaiser Permanente Northwest RegionCenter for Health Research
Portland, Oregon, 97227, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
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
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Gunderson Clinic
La Crosse, Wisconsin, 54601, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Oncology Alliance
Milwaukee, Wisconsin, 53215, United States
University of Calgary
Calgary, Alberta, 2N 4N1, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
Vancouver, British Columbia, V5Z 4E3, Canada
Dalhousie University Queen Elizabeth II Health Services Centre
Halifax, Nova Scotia, B3H2Y9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5J 2M9, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Related Publications (1)
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.
PMID: 19332768DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert D. Knight, M.D.
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Robert Knight, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
September 1, 2005
Primary Completion
December 1, 2008
Study Completion
April 1, 2009
Last Updated
March 16, 2010
Results First Posted
March 3, 2010
Record last verified: 2010-03