Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098475
First received: December 7, 2004
Last updated: July 25, 2016
Last verified: June 2016
  Purpose
This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Condition Intervention Phase
DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Thalidomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-responders

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of Patients With Objective Response (First Phase, Step 1) [ Time Frame: Assessed every 4 weeks for 16 weeks during Step 1 ] [ Designated as safety issue: No ]

    Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).

    As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.



Secondary Outcome Measures:
  • Proportion of Patients With Objective Response (First Phase, Step 2) [ Time Frame: Assessed every 4 weeks for 16 weeks during Step 2 ] [ Designated as safety issue: No ]

    Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).

    As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.



Enrollment: 452
Study Start Date: October 2004
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
Experimental: 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.
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
Active Comparator: 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
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Thalidomide
Given PO
Other Names:
  • (+)-Thalidomide
  • (-)-Thalidomide
  • .alpha.-Phthalimidoglutarimide
  • 2, 6-Dioxo-3-phthalimidopiperidine
  • Alpha-Phthalimidoglutarimide
  • Contergan
  • Distaval
  • Kevadon
  • N-(2,6-Dioxo-3-piperidyl)phthalimide
  • N-Phthaloylglutamimide
  • N-Phthalylglutamic Acid Imide
  • Neurosedyn
  • Pantosediv
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-
  • Sedalis
  • Sedoval K-17
  • Softenon
  • Synovir
  • Talimol
  • Thalomid
Experimental: 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.
Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Thalidomide
Given PO
Other Names:
  • (+)-Thalidomide
  • (-)-Thalidomide
  • .alpha.-Phthalimidoglutarimide
  • 2, 6-Dioxo-3-phthalimidopiperidine
  • Alpha-Phthalimidoglutarimide
  • Contergan
  • Distaval
  • Kevadon
  • N-(2,6-Dioxo-3-piperidyl)phthalimide
  • N-Phthaloylglutamimide
  • N-Phthalylglutamic Acid Imide
  • Neurosedyn
  • Pantosediv
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-
  • Sedalis
  • Sedoval K-17
  • Softenon
  • Synovir
  • Talimol
  • Thalomid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be diagnosed with symptomatic multiple myeloma within the past 90 days confirmed by the following:

    • 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
  • No prior systemic therapy with the exception of bisphosphonates for multiple myeloma
  • 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
  • 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
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098475

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Huntsville Hospital
Huntsville, Alabama, United States, 35801
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Saint Jude Medical Center
Fullerton, California, United States, 92835
El Camino Hospital
Mountain View, California, United States, 94040
Kaiser Permanente-San Diego Mission
San Diego, California, United States, 92108
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
McKee Medical Center
Loveland, Colorado, United States, 80539
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
University of Florida
Gainesville, Florida, United States, 32610
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Martin Hospital South
Stuart, Florida, United States, 34997
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Atlanta Regional CCOP
Atlanta, Georgia, United States, 30342
Augusta Oncology Associates PC-Saint Sebastian
Augusta, Georgia, United States, 30901
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Saint Anthony's Health
Alton, Illinois, United States, 62002
Northwestern University
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
AMITA Health Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Hines Veterans Administration Hospital
Hines, Illinois, United States, 60141
Midwest Center for Hematology Oncology
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Swedish American Hospital
Rockford, Illinois, United States, 61104
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61114
Edward H Kaplan MD and Associates
Skokie, Illinois, United States, 60076
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
IU Health Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States, 52722
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Covenant Medical Center
Waterloo, Iowa, United States, 50702
United States, Kansas
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States, 66208
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
HealthAlliance Hospital - Leominster
Leominster, Massachusetts, United States, 01453
United States, Michigan
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Mayo Clinic
Rochester, Minnesota, United States, 55905
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
United States, Montana
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59101
Great Falls Clinic
Great Falls, Montana, United States, 59405
United States, Nebraska
Nebraska Cancer Research Center
Lincoln, Nebraska, United States, 68510
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Midlands Community Hospital
Papillion, Nebraska, United States, 68046
United States, New Jersey
Hackensack University Medical CCOP
Hackensack, New Jersey, United States, 07601
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, United States, 08690
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Virtua Memorial
Mount Holly, New Jersey, United States, 08060
Jersey Shore Medical Center
Neptune, New Jersey, United States, 07753
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08876
United States, New York
Orange Regional Medical Center
Middletown, New York, United States, 10940
Winthrop University Hospital
Mineola, New York, United States, 11501
Beth Israel Medical Center
New York, New York, United States, 10003
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States, 27104
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Kettering Medical Center
Kettering, Ohio, United States, 45429
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Chestnut Hill Health System
Philadelphia, Pennsylvania, United States, 19118
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17403
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22901
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Lynchburg Hematology-Oncology Clinic
Lynchburg, Virginia, United States, 24501
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
United States, West Virginia
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Fox Valley Hematology and Oncology SC-Appleton
Appleton, Wisconsin, United States, 54913
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: S. Rajkumar ECOG-ACRIN Cancer Research Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098475     History of Changes
Other Study ID Numbers: NCI-2012-03150  NCI-2012-03150  CDR0000404161  E4A03  E4A03  U10CA180820  U10CA021115 
Study First Received: December 7, 2004
Results First Received: August 30, 2013
Last Updated: July 25, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
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

ClinicalTrials.gov processed this record on September 23, 2016