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Trial record 11 of 376 for:    LENALIDOMIDE AND Dexamethasone

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00179647
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : March 3, 2010
Last Update Posted : March 16, 2010
Sponsor:
Collaborator:
Prologue Research International
Information provided by:
Celgene

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: lenalidomide Drug: dexamethasone Phase 3

Expanded Access : Celgene Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1913 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009


Arm Intervention/treatment
Lenalidomide 5-25 mg, w/wo dexamethasone
single-arm, open-label, lenalidomide, 5-25 mg, 21/28 days, with/without dexamethasone
Drug: lenalidomide
Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone
Other Name: Revlimid

Drug: dexamethasone
Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens
Other Name: Decadron




Primary Outcome Measures :
  1. Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment. [ Time Frame: Median time-on-study=18.3 weeks ]
    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.

  2. Overall Incidence of Adverse Events [ Time Frame: Median time-on-study=18.3 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179647


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Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Alta Bates Cancer Center
Berkeley, California, United States, 94704
Scripps Cancer Center
La Jolla, California, United States, 93037
Cedar Sinai Medical CenterDept of Medicine
Los Angeles, California, United States, 90048
Kaiser Permanente Medical Group
San Diego, California, United States, 32120
Stanford Cancer Center
Stanford, California, United States, 94305-5750
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
United States, Colorado
University of ColoradoHealth Science Center
Aurora, Colorado, United States, 80045-0510
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, United States, 80218
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Hematology Oncology, PC
Stamford, Connecticut, United States, 06902
United States, Delaware
Delaware Clinical & Laboratory Physicians, PA
Newark, Delaware, United States, 19713
United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
University of Miami Medical School
Miami, Florida, United States, 33136
Gulf Coast Oncology
St. Petersburg, Florida, United States, 33705
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497
The Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Med CtrDivision of Hem/Onc
Chicago, Illinois, United States, 60611-2927
Rush Cancer Institute
Chicago, Illinois, United States, 60612-3824
United States, Indiana
Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research Institute
Indianapolis, Indiana, United States, 46202-5254
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7233
Wichita CCOP
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland Medical Center Greenbaum Cancer Ctr
Baltimore, Maryland, United States, 21201-1595
Center for Cancer And Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Montana
Deaconess Billings Clinic
Billings, Montana, United States, 59102
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Dartmouth Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
New York Medical Center, MBCCOP
Bronx, New York, United States, 10466
SUNY Health Science Center - Brooklyn
Brooklyn, New York, United States, 11203
North Shore Hematology/Oncology Associates, PC
East Setauket, New York, United States, 11733
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
NY Presbyterian Hospital/Weill Medical College-Cornell University
New York, New York, United States, 10021
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States, 28203
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157-1023
United States, North Dakota
Dakota Cancer Institute
Fargo, North Dakota, United States, 58108-6001
United States, Ohio
Mid Ohio Oncology & Hematology, Inc.
Columbus, Ohio, United States, 43215
United States, Oregon
Kaiser Permanente Northwest RegionCenter for Health Research
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston Hematology/Oncology P.A.
Charleston, South Carolina, United States, 29403
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
South Carolina Oncology Assoc
Columbia, South Carolina, United States, 29210
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9016
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Intermountain Hematology/Oncology
Salt Lake City, Utah, United States, 84124
United States, Virginia
Medical College of Virginis, North Hospital
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
United States, Wisconsin
Gunderson Clinic
LaCrosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Oncology Alliance
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, 2N 4N1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
Vancouver, British Columbia, Canada, V5Z 4E3
Canada, Nova Scotia
Dalhousie University Queen Elizabeth II Health Services Centre
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5J 2M9
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Celgene Corporation
Prologue Research International
Investigators
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Study Director: Robert Knight, MD Celgene Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Knight, MD / Vice President, Clinical Research - Hematology, Celgene Corporation
ClinicalTrials.gov Identifier: NCT00179647     History of Changes
Obsolete Identifiers: NCT00331903
Other Study ID Numbers: CC-5013-MM-016
First Posted: September 16, 2005    Key Record Dates
Results First Posted: March 3, 2010
Last Update Posted: March 16, 2010
Last Verified: March 2010
Keywords provided by Celgene:
Multiple Myeloma
MM
Revlimid
CC5013
celgene
cc-5013
relapsed/refractory
lenalidomide
dexamethasone
Decadron
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors