Phase
Condition
Multiple Myeloma
Platelet Disorders
Leukemia
Treatment
Laboratory Biomarker Analysis
Peripheral Blood Stem Cell Transplantation
Placebo Administration
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have active multiple myeloma requiring treatment (Durie-Salmon stage >= 1) and have stable disease or be responsive to at least 2 months of any induction therapy; patients with smoldering myeloma are not eligible unless the disease has progressed to >= stage 1
No more than 12 months of any prior therapy, including CC-5013 and thalidomide
Within 12 months of initiation of induction therapy
No prior progression after initial therapy; in addition, no more than two regimens will be allowed excluding dexamethasone alone
No prior peripheral blood, bone marrow, or solid organ transplant
Patients must have peripheral blood stem cell collection of >= 2 x 10^6 cluster of differentiation (CD)34+ cells/kg (patient body weight) and preferably 5 x 10^6 cells/kg (patient body weight); stem cells may be collected at any time prior to transplant; peripheral blood stem cell collection may occur before or after registration
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Patients must have diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease
Patients must have left ventricular ejection fraction (LVEF) >= 40% by multi gated acquisition scan (MUGA) or echocardiogram
Patients must not have uncontrolled diabetes mellitus
Patients must not have an active serious infection
Patients must not be human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSag), or hepatitis (Hep) C positive
Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL 10-14 days prior to registration and repeated within 24 hours prior to the first dose of lenalidomide; in addition, women of childbearing potential taking lenalidomide must have a pregnancy test performed by the doctor weekly during the first 4 weeks of treatment, and then every 4 weeks if menses are regular and every 2 weeks if menses are irregular, and then 30 days following the last dose of lenalidomide; women of childbearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (intrauterine device [IUD], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (latex condom, diaphragm, or cervical cap) - at the same time, at least 4 weeks before she begins lenalidomide therapy; "women of childbearing" potential is defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months; men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy
Absolute neutrophil count (ANC) >= 1000/uL
Platelets >= 100,000/uL
Creatinine clearance* >= 40 cc/min
To be calculated by method of Cockcroft-Gault or after 24-hour urine collection
Creatinine =< 2 mg/dL
Total bilirubin =< 2 mg/dL
Aspartate aminotransferase (AST) =< 3 x upper limits of normal
Alkaline phosphatase =< 3 x upper limits of normal
Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative (if patient of childbearing potential)
Study Design
Study Description
Connect with a study center
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United StatesSite Not Available
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United StatesSite Not Available
Rebecca and John Moores UCSD Cancer Center
La Jolla, California 92093-0658
United StatesSite Not Available
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United StatesSite Not Available
UC San Diego Medical Center - Hillcrest
San Diego, California 92103
United StatesSite Not Available
UCSF Medical Center-Mount Zion
San Francisco, California 94115
United StatesSite Not Available
The Medical Center of Aurora
Aurora, Colorado 80012
United StatesSite Not Available
Boulder Community Hospital
Boulder, Colorado 80301
United StatesSite Not Available
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
United StatesSite Not Available
AdventHealth Porter
Denver, Colorado 80210
United StatesSite Not Available
Porter Adventist Hospital
Denver, Colorado 80210
United StatesSite Not Available
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218
United StatesSite Not Available
Rose Medical Center
Denver, Colorado 80220
United StatesSite Not Available
SCL Health Saint Joseph Hospital
Denver, Colorado 80218
United StatesSite Not Available
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado 80218
United StatesSite Not Available
Western States Cancer Research NCORP
Denver, Colorado 80222
United StatesSite Not Available
Swedish Medical Center
Englewood, Colorado 80113
United StatesSite Not Available
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado 81501
United StatesSite Not Available
Banner North Colorado Medical Center
Greeley, Colorado 80631
United StatesSite Not Available
North Colorado Medical Center
Greeley, Colorado 80631
United StatesSite Not Available
Saint Anthony Hospital
Lakewood, Colorado 80228
United StatesSite Not Available
Sky Ridge Medical Center
Lone Tree, Colorado 80124
United StatesSite Not Available
Longmont United Hospital
Longmont, Colorado 80501
United StatesSite Not Available
Banner McKee Medical Center
Loveland, Colorado 80539
United StatesSite Not Available
McKee Medical Center
Loveland, Colorado 80539
United StatesSite Not Available
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
United StatesSite Not Available
North Suburban Medical Center
Thornton, Colorado 80229
United StatesSite Not Available
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado 80401
United StatesSite Not Available
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado 80033
United StatesSite Not Available
Beebe Medical Center
Lewes, Delaware 19958
United StatesSite Not Available
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United StatesSite Not Available
Saint Francis Hospital - Wilmington
Wilmington, Delaware 19805
United StatesSite Not Available
George Washington University Medical Center
Washington, District of Columbia 20037
United StatesSite Not Available
George Washington University Medical Center
Washington, D.C., District of Columbia 20037
United StatesSite Not Available
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
United StatesSite Not Available
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United StatesSite Not Available
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United StatesSite Not Available
Northside Hospital
Atlanta, Georgia 30342
United StatesSite Not Available
Augusta University Medical Center
Augusta, Georgia 30912
United StatesSite Not Available
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
United StatesSite Not Available
OSF Saint Joseph Medical Center
Bloomington, Illinois 61701
United StatesSite Not Available
Saint Joseph Medical Center
Bloomington, Illinois 61701
United StatesSite Not Available
Graham Hospital Association
Canton, Illinois 61520
United StatesSite Not Available
Memorial Hospital
Carthage, Illinois 62321
United StatesSite Not Available
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United StatesSite Not Available
University of Illinois
Chicago, Illinois 60612
United StatesSite Not Available
Heartland Cancer Research NCORP
Decatur, Illinois 62526
United StatesSite Not Available
Eureka Hospital
Eureka, Illinois 61530
United StatesSite Not Available
Galesburg Cottage Hospital
Galesburg, Illinois 61401
United StatesSite Not Available
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United StatesSite Not Available
Mason District Hospital
Havana, Illinois 62644
United StatesSite Not Available
Hopedale Medical Complex - Hospital
Hopedale, Illinois 61747
United StatesSite Not Available
Kewanee Hospital
Kewanee, Illinois 61443
United StatesSite Not Available
Mcdonough District Hospital
Macomb, Illinois 61455
United StatesSite Not Available
Bromenn Regional Medical Center
Normal, Illinois 61761
United StatesSite Not Available
Carle BroMenn Medical Center
Normal, Illinois 61761
United StatesSite Not Available
Carle Cancer Institute Normal
Normal, Illinois 61761
United StatesSite Not Available
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United StatesSite Not Available
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois 61350
United StatesSite Not Available
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois 61554
United StatesSite Not Available
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois 61554
United StatesSite Not Available
Pekin Hospital
Pekin, Illinois 61554
United StatesSite Not Available
Illinois CancerCare-Peoria
Peoria, Illinois 61615
United StatesSite Not Available
Methodist Medical Center of Illinois
Peoria, Illinois 61636
United StatesSite Not Available
OSF Saint Francis Medical Center
Peoria, Illinois 61637
United StatesSite Not Available
Proctor Hospital
Peoria, Illinois 61614
United StatesSite Not Available
Illinois Valley Hospital
Peru, Illinois 61354
United StatesSite Not Available
Perry Memorial Hospital
Princeton, Illinois 61356
United StatesSite Not Available
Saint Margaret's Hospital
Spring Valley, Illinois 61362
United StatesSite Not Available
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Providence Medical Center
Kansas City, Kansas 66112
United StatesSite Not Available
Lawrence Memorial Hospital
Lawrence, Kansas 66044
United StatesSite Not Available
Menorah Medical Center
Overland Park, Kansas 66209
United StatesSite Not Available
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas 66210
United StatesSite Not Available
Advent Health - Shawnee Mission Medical Center
Shawnee Mission, Kansas 66204
United StatesSite Not Available
AdventHealth Shawnee Mission
Shawnee Mission, Kansas 66204
United StatesSite Not Available
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
United StatesSite Not Available
Christiana Care - Union Hospital
Elkton, Maryland 21921
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Centerpoint Medical Center LLC
Independence, Missouri 64057
United StatesSite Not Available
North Kansas City Hospital
Kansas City, Missouri 64116
United StatesSite Not Available
Radiation Oncology Practice Corporation - North
Kansas City, Missouri 64154
United StatesSite Not Available
Radiation Oncology Practice Corporation South
Kansas City, Missouri 64114
United StatesSite Not Available
Research Medical Center
Kansas City, Missouri 64132
United StatesSite Not Available
Saint Joseph Health Center
Kansas City, Missouri 64114
United StatesSite Not Available
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United StatesSite Not Available
Truman Medical Centers
Kansas City, Missouri 64108
United StatesSite Not Available
University Health Truman Medical Center
Kansas City, Missouri 64108
United StatesSite Not Available
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri 64086
United StatesSite Not Available
Liberty Hospital
Liberty, Missouri 64068
United StatesSite Not Available
Liberty Radiation Oncology Center
Liberty, Missouri 64068
United StatesSite Not Available
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Cooper Hospital University Medical Center
Camden, New Jersey 08103
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United StatesSite Not Available
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United StatesSite Not Available
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
United StatesSite Not Available
Montefiore Medical Center-Wakefield Campus
Bronx, New York 10466
United StatesSite Not Available
Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesSite Not Available
Northwell Health NCORP
Lake Success, New York 11042
United StatesSite Not Available
North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
Long Island Jewish Medical Center
New Hyde Park, New York 11040
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
NYP/Weill Cornell Medical Center
New York, New York 10065
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
State University of New York Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
Montefiore Medical Center-Weiler Hospital
The Bronx, New York 10461
United StatesSite Not Available
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
The Jewish Hospital
Cincinnati, Ohio 45236
United StatesSite Not Available
Case Western Reserve University
Cleveland, Ohio 44106
United StatesSite Not Available
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Providence Portland Medical Center
Portland, Oregon 97213
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania 18201
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Geisinger Medical Group
State College, Pennsylvania 16801
United StatesSite Not Available
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
United StatesSite Not Available
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
United StatesSite Not Available
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
United StatesSite Not Available
Saint Francis Hospital
Greenville, South Carolina 29601
United StatesSite Not Available
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United StatesSite Not Available
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
M D Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
LDS Hospital
Salt Lake City, Utah 84143
United StatesSite Not Available
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
United StatesSite Not Available
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont 05602
United StatesSite Not Available
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United StatesSite Not Available
Virginia Oncology Associates-Hampton
Hampton, Virginia 23666
United StatesSite Not Available
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
United StatesSite Not Available
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United StatesSite Not Available
Saint Mary's Medical Center
Huntington, West Virginia 25702
United StatesSite Not Available
Aurora Cancer Care-Glendale
Glendale, Wisconsin 53212
United StatesSite Not Available
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United StatesSite Not Available
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin 54501
United StatesSite Not Available
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
United StatesSite Not Available
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
United StatesSite Not Available
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