Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
NCT ID: NCT00098475
Last Updated: 2025-11-28
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
452 participants
INTERVENTIONAL
2004-11-03
2026-10-23
Brief Summary
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Detailed Description
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I. To evaluate the response rate and toxicity of lenalidomide (CC-5013) plus dexamethasone (standard dose) versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity (First Phase).
SECONDARY OBJECTIVES:
I. To evaluate the response rate of thalidomide plus dexamethasone (Thal/Dex) in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms (First Phase).
II. To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade, on plasma cell labeling index (PCLI), and on the expression of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the marrow (First Phase).
III. To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells (MPCs) (First Phase).
IV. To evaluate in a separate expansion phase the efficacy of aspirin (325 mg/day) versus Coumadin (dose adjusted to maintain a target international normalized ratio \[INR\] of 2-3) in preventing deep vein thrombosis (DVT) in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Arm II: Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
In both arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 cycles of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively.
Arm III (patients with no response after treatment on Arm I): Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Arm IV (patients with no response after treatment on Arm II): Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
In both salvage therapy arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 cycles of therapy, patients may undergo stem cell harvest (using growth factors only) for cryopreservation.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (lenalidomide, dexamethasone)
Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Dexamethasone
Given PO
Laboratory Biomarker Analysis
Optional correlative studies
Lenalidomide
Given PO
Arm II (lenalidomide, low-dose dexamethasone)
Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Dexamethasone
Given PO
Laboratory Biomarker Analysis
Optional correlative studies
Lenalidomide
Given PO
Arm III (thalidomide, dexamethasone)
Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20
Dexamethasone
Given PO
Laboratory Biomarker Analysis
Optional correlative studies
Thalidomide
Given PO
Arm IV (thalidomide, low-dose dexamethasone)
Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Dexamethasone
Given PO
Laboratory Biomarker Analysis
Optional correlative studies
Thalidomide
Given PO
Interventions
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Dexamethasone
Given PO
Laboratory Biomarker Analysis
Optional correlative studies
Lenalidomide
Given PO
Thalidomide
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bone marrow plasmacytosis with \>= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma which must be obtained within 4 weeks prior to randomization
* Measurable levels of monoclonal protein (M protein): \>= 1.0 g/dL on serum protein electrophoresis or \>= 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization; both serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) are required to be performed within 28 days prior to randomization; please note that if both serum and urine m-components are present, both must be followed in order to evaluate response
* Hemoglobin \> 7 g/dL
* Platelet count \> 75,000 cells/mm\^3
* Absolute neutrophil count \> 1000 cells/mm\^3
* Creatinine \< 2.5 mg/dL and creatinine clearance (measured or calculated) \>= 60 mL/min
* Bilirubin =\< 1.5 mg/dL
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 times the upper limit of normal
* Prior palliative and/or localized radiation therapy is permitted provided at least 4 weeks have passed from date of last radiation therapy to date of registration; patients with prior solitary plasmacytoma treated with radiation therapy with curative intent are eligible if the disease has now progressed to active multiple myeloma meeting all the eligibility criteria for this protocol
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method (intrauterine device \[IUD\], birth control pills, tubal ligation or partner's vasectomy) and one additional effective method (condom, diaphragm or cervical cap); FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy starting 4 weeks prior to and while taking CC5013 or thalidomide and for four weeks after discontinuing this therapy; a FCBP is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
* Patients with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months
Exclusion Criteria
* Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted; prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day; prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted
* Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months
* Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome
* Patients with smoldering myeloma or monoclonal gammopathy of undetermined significance are not eligible
* Patients must not have grade 2 or higher peripheral neuropathy due to other medical conditions at the time of randomization
* Patients must not have active, uncontrolled infection
* Patients must not have a history of current or previous deep vein thrombosis or pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy
* For patients registered prior to activation of Addendum # 6; patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or Coumadin
* For patients registered after activation of Addendum # 6; patients entering the expansion phase of the protocol, which tests anticoagulant prophylaxis, must be able and willing to be randomized between aspirin at 325 mg/day and Coumadin
* Female patients MUST NOT be pregnant or breastfeeding; due to the potential teratogenic properties of CC 5013, and the known teratogenicity associated with thalidomide, the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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S. V Rajkumar
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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Kaiser Permanente-San Diego Mission
San Diego, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Saint Jude Medical Center
Fullerton, California, United States
El Camino Hospital
Mountain View, California, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Martin Hospital South
Stuart, Florida, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Atlanta Regional CCOP
Atlanta, Georgia, United States
Augusta Oncology Associates PC-D'Antignac
Augusta, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Atrium Health Navicent
Macon, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Northwestern University
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Ascension Alexian Brothers - Elk Grove Village
Elk Grove Village, Illinois, United States
Edward Hines Jr VA Hospital
Hines, Illinois, United States
Midwest Center for Hematology Oncology
Joliet, Illinois, United States
Duly Health and Care Joliet
Joliet, Illinois, United States
Swedish American Hospital
Rockford, Illinois, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, United States
Edward H Kaplan MD and Associates
Skokie, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
IU Health Arnett Cancer Care
Lafayette, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
McFarland Clinic - Ames
Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
MercyOne Waterloo Cancer Center
Waterloo, Iowa, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
HealthAlliance Hospital - Leominster
Leominster, Massachusetts, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Midlands Community Hospital
Papillion, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Garnet Health Medical Center
Middletown, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Mount Sinai Union Square
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Jefferson Abington Hospital
Abington, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple Health - Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Grand View Hospital
Sellersville, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Sentara Martha Jefferson Hospital
Charlottesville, Virginia, United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
SSM Health Dean Medical Group - South Madison Campus
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Countries
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References
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Baker A, Braggio E, Jacobus S, Jung S, Larson D, Therneau T, Dispenzieri A, Van Wier SA, Ahmann G, Levy J, Perkins L, Kim S, Henderson K, Vesole D, Rajkumar SV, Jelinek DF, Carpten J, Fonseca R. Uncovering the biology of multiple myeloma among African Americans: a comprehensive genomics approach. Blood. 2013 Apr 18;121(16):3147-52. doi: 10.1182/blood-2012-07-443606. Epub 2013 Feb 19.
Kumar SK, Uno H, Jacobus SJ, Van Wier SA, Ahmann GJ, Henderson KJ, Callander NS, Haug JL, Siegel DS, Greipp PR, Fonseca R, Rajkumar SV. Impact of gene expression profiling-based risk stratification in patients with myeloma receiving initial therapy with lenalidomide and dexamethasone. Blood. 2011 Oct 20;118(16):4359-62. doi: 10.1182/blood-2011-03-342089. Epub 2011 Aug 22.
Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, Abonour R, Siegel DS, Katz M, Greipp PR; Eastern Cooperative Oncology Group. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010 Jan;11(1):29-37. doi: 10.1016/S1470-2045(09)70284-0. Epub 2009 Oct 21.
Other Identifiers
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NCI-2012-03150
Identifier Type: REGISTRY
Identifier Source: secondary_id
E4A03
Identifier Type: -
Identifier Source: secondary_id
CDR0000404161
Identifier Type: -
Identifier Source: secondary_id
E4A03
Identifier Type: OTHER
Identifier Source: secondary_id
E4A03
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-03150
Identifier Type: -
Identifier Source: org_study_id
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