Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
NCT ID: NCT00114101
Last Updated: 2025-11-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
460 participants
INTERVENTIONAL
2004-12-15
2026-02-22
Brief Summary
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Detailed Description
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I. To determine the efficacy of CC-5013 (lenalidomide) in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant (ASCT).
SECONDARY OBJECTIVES:
I. To determine if CC-5013 will increase the complete response (CR) rate in patients with multiple myeloma following ASCT.
II. To compare the progression-free survival (PFS) and overall survival (OS) in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo.
III. To determine the feasibility of long-term administration of CC-5013 to multiple myeloma patients who have undergone ASCT.
OUTLINE:
PERIPHERAL BLOOD STEM CELL (PBSC) MOBILIZATION: Mobilization of autologous PBSC will be performed according to institutional guidelines.
AUTOLOGOUS PBSC TRANSPLANTATION (PBSCT): Patients receive melphalan intravenously (IV) over 30-60 minutes on day -2 or -1 or over 2 days on days -3 and -2 or -2 and -1. Patients undergo autologous PBSCT on day 0.
Patients are then randomized to 1 of 2 maintenance treatment arms. (Note: As of 12/17/09, no more patients will be randomized between lenalidomide and placebo. Patients who have not been randomized as of 12/17/09 will be assigned to lenalidomide.)
ARM I: Beginning between day 100-110, patients receive lenalidomide orally (PO) once daily.
ARM II: Beginning between day 100-110, patients receive placebo (PO) once daily.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (melphalan, autologous PBSCT, lenalidomide)
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSCT
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Melphalan
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo autologous PBSCT
Arm II (melphalan, autologous PBSCT, placebo)
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSCT
Laboratory Biomarker Analysis
Correlative studies
Melphalan
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo autologous PBSCT
Placebo Administration
Given PO
Interventions
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Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSCT
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Melphalan
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo autologous PBSCT
Placebo Administration
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
70 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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Philip L McCarthy
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western States Cancer Research NCORP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Saint Francis Hospital - Wilmington
Wilmington, Delaware, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Carle BroMenn Medical Center
Normal, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Providence Medical Center
Kansas City, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas, United States
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Christiana Care - Union Hospital
Elkton, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Centerpoint Medical Center LLC
Independence, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Radiation Oncology Practice Corporation South
Kansas City, Missouri, United States
Saint Joseph Health Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Radiation Oncology Practice Corporation - North
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Hospital
Liberty, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Mount Sinai Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center-Wakefield Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Jewish Hospital
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Virginia Oncology Associates-Hampton
Hampton, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Saint Mary's Medical Center
Huntington, West Virginia, United States
Aurora Cancer Care-Glendale
Glendale, 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
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Countries
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References
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Holstein SA, Jung SH, Richardson PG, Hofmeister CC, Hurd DD, Hassoun H, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, van Besien K, Gentile TG, Isola L, Maziarz RT, Bashey A, Landau H, Martin T, Qazilbash MH, Rodriguez C, McClune B, Schlossman RL, Smith SE, Hars V, Owzar K, Jiang C, Boyd M, Schultz C, Wilson M, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Linker C, Anderson KC, McCarthy PL. Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol. 2017 Sep;4(9):e431-e442. doi: 10.1016/S2352-3026(17)30140-0. Epub 2017 Aug 17.
McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, Giralt S, Stadtmauer EA, Weisdorf DJ, Vij R, Moreb JS, Callander NS, Van Besien K, Gentile T, Isola L, Maziarz RT, Gabriel DA, Bashey A, Landau H, Martin T, Qazilbash MH, Levitan D, McClune B, Schlossman R, Hars V, Postiglione J, Jiang C, Bennett E, Barry S, Bressler L, Kelly M, Seiler M, Rosenbaum C, Hari P, Pasquini MC, Horowitz MM, Shea TC, Devine SM, Anderson KC, Linker C. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1770-81. doi: 10.1056/NEJMoa1114083.
Other Identifiers
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NCI-2009-00439
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB 100104/ECOG 100104
Identifier Type: -
Identifier Source: secondary_id
CDR0000434845
Identifier Type: -
Identifier Source: secondary_id
CALGB-100104
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-100104
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00439
Identifier Type: -
Identifier Source: org_study_id
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