Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified January 2026 by National Cancer Institute (NCI)
Sponsor
National Cancer Institute (NCI)
Information Provided by (Responsible Party)
National Cancer Institute (NCI)
Clinicaltrials.gov Identifier
NCT00114101
Other Study ID Numbers:
NCI-2009-00439
First Submitted
June 12, 2005
First Posted
June 13, 2005
Results First Posted
March 27, 2013
Last Update Posted
July 1, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

PRIMARY OBJECTIVE:

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.

Condition or DiseaseIntervention/Treatment
DS Stage I Multiple MyelomaDS Stage II Multiple MyelomaDS Stage III Multiple MyelomaRefractory Multiple MyelomaSmoldering Multiple Myeloma
Procedure: Autologous Hematopoietic Stem Cell TransplantationProcedure: Autologous Hematopoietic Stem Cell Transplantation

Study Design

Study TypeInterventional
Actual Enrollment460 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma
Study Start DateDecember 14, 2004
Actual Primary Completion DateDecember 30, 2012
Actual Study Completion Date7mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Procedure: Autologous Hematopoietic 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.
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSCT

Outcome Measures

Primary Outcome Measures
  1. Time to Progression
    Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas * Development of hypercalcemia
Secondary Outcome Measures
  1. Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
    Response was defined according to International Myeloma Working Group criteria (2006) * Complete Response: Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Partial Response: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels * Marginal Response: 25-49% reduction in serum M-component \& urine M-component by 50-89% which still exceeds 200mg/24hour * Progressive Disease: Defined in primary outcome measure * Stable Disease: Not meeting any of the criteria above

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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)
Exclusion Criteria
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)

Contacts and Locations

Sponsors and CollaboratorsNational Cancer Institute (NCI)
Locations
Mayo Clinic in Arizona | Scottsdale Arizona, United States, 85259City of Hope Comprehensive Cancer Center | Duarte California, United States, 91010University of California Davis Comprehensive Cancer Center | Sacramento California, United States, 95817UC San Diego Medical Center - Hillcrest | San Diego California, United States, 92103UCSF Medical Center-Mount Zion | San Francisco California, United States, 94115The Medical Center of Aurora | Aurora Colorado, United States, 80012Boulder Community Foothills Hospital | Boulder Colorado, United States, 80303Penrose-Saint Francis Healthcare | Colorado Springs Colorado, United States, 80907AdventHealth Porter | Denver Colorado, United States, 80210Presbyterian - Saint Lukes Medical Center - Health One | Denver Colorado, United States, 80218Saint Joseph Hospital - Cancer Centers of Colorado | Denver Colorado, United States, 80218Rose Medical Center | Denver Colorado, United States, 80220Western States Cancer Research NCORP | Denver Colorado, United States, 80222Swedish Medical Center | Englewood Colorado, United States, 80113Saint Mary's Hospital and Regional Medical Center | Grand Junction Colorado, United States, 81501Banner North Colorado Medical Center | Greeley Colorado, United States, 80631CommonSpirit Saint Anthony Hospital Cancer Center | Lakewood Colorado, United States, 80228Sky Ridge Medical Center | Lone Tree Colorado, United States, 80124Longmont United Hospital | Longmont Colorado, United States, 80501Banner North Colorado Medical Center - Loveland Campus | Loveland Colorado, United States, 80539Saint Mary Corwin Medical Center | Pueblo Colorado, United States, 81004North Suburban Medical Center | Thornton Colorado, United States, 80229Intermountain Health Lutheran Hospital | Wheat Ridge Colorado, United States, 80401Beebe Medical Center | Lewes Delaware, United States, 19958Christiana Care Health System-Christiana Hospital | Newark Delaware, United States, 19718Saint Francis Hospital - Wilmington | Wilmington Delaware, United States, 19805George Washington University Medical Center | Washington D.C. District of Columbia, United States, 20037UF Health Cancer Institute - Gainesville | Gainesville Florida, United States, 32610Mayo Clinic in Florida | Jacksonville Florida, United States, 32224-9980University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami Florida, United States, 33136Northside Hospital | Atlanta Georgia, United States, 30342Augusta University Medical Center | Augusta Georgia, United States, 30912Saint Luke's Cancer Institute - Boise | Boise Idaho, United States, 83712OSF Saint Joseph Medical Center | Bloomington Illinois, United States, 61701Graham Hospital Association | Canton Illinois, United States, 61520Memorial Hospital | Carthage Illinois, United States, 62321Jesse Brown Veterans Affairs Medical Center | Chicago Illinois, United States, 60612University of Illinois | Chicago Illinois, United States, 60612University of Chicago Comprehensive Cancer Center | Chicago Illinois, United States, 60637Heartland Cancer Research NCORP | Decatur Illinois, United States, 62526Eureka Hospital | Eureka Illinois, United States, 61530Galesburg Cottage Hospital | Galesburg Illinois, United States, 61401Illinois CancerCare-Galesburg | Galesburg Illinois, United States, 61401Mason District Hospital | Havana Illinois, United States, 62644Hopedale Medical Complex - Hospital | Hopedale Illinois, United States, 61747Kewanee Hospital | Kewanee Illinois, United States, 61443Mcdonough District Hospital | Macomb Illinois, United States, 61455Carle BroMenn Medical Center | Normal Illinois, United States, 61761Carle Cancer Institute Normal | Normal Illinois, United States, 61761Illinois CancerCare-Ottawa Clinic | Ottawa Illinois, United States, 61350Ottawa Regional Hospital and Healthcare Center | Ottawa Illinois, United States, 61350OSF Saint Francis Radiation Oncology at Pekin | Pekin Illinois, United States, 61554Pekin Hospital | Pekin Illinois, United States, 61554Proctor Hospital | Peoria Illinois, United States, 61614Illinois CancerCare-Peoria | Peoria Illinois, United States, 61615Methodist Medical Center of Illinois | Peoria Illinois, United States, 61636OSF Saint Francis Medical Center | Peoria Illinois, United States, 61637Illinois Valley Hospital | Peru Illinois, United States, 61354Perry Memorial Hospital | Princeton Illinois, United States, 61356Saint Margaret's Hospital | Spring Valley Illinois, United States, 61362Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis Indiana, United States, 46202Providence Medical Center | Kansas City Kansas, United States, 66112Lawrence Memorial Hospital | Lawrence Kansas, United States, 66044Menorah Medical Center | Overland Park Kansas, United States, 66209Radiation Oncology Practice Corporation Southwest | Overland Park Kansas, United States, 66210AdventHealth Shawnee Mission | Shawnee Mission Kansas, United States, 66204Walter Reed National Military Medical Center | Bethesda Maryland, United States, 20889-5600Christiana Care - Union Hospital | Elkton Maryland, United States, 21921Brigham and Women's Hospital | Boston Massachusetts, United States, 02115Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02215Lahey Clinic | Burlington Massachusetts, United States, 01805University of Minnesota/Masonic Cancer Center | Minneapolis Minnesota, United States, 55455Mayo Clinic in Rochester | Rochester Minnesota, United States, 55905University of Mississippi Medical Center | Jackson Mississippi, United States, 39216Centerpoint Medical Center LLC | Independence Missouri, United States, 64057University Health Truman Medical Center | Kansas City Missouri, United States, 64108Saint Luke's Hospital of Kansas City | Kansas City Missouri, United States, 64111Radiation Oncology Practice Corporation South | Kansas City Missouri, United States, 64114Saint Joseph Health Center | Kansas City Missouri, United States, 64114North Kansas City Hospital | Kansas City Missouri, United States, 64116Research Medical Center | Kansas City Missouri, United States, 64132Radiation Oncology Practice Corporation - North | Kansas City Missouri, United States, 64154Saint Luke's East - Lee's Summit | Lee's Summit Missouri, United States, 64086Liberty Hospital | Liberty Missouri, United States, 64068Heartland Regional Medical Center | Saint Joseph Missouri, United States, 64506Washington University School of Medicine | St Louis Missouri, United States, 63110University of Nebraska Medical Center | Omaha Nebraska, United States, 68198Cooper Hospital University Medical Center | Camden New Jersey, United States, 08103Rutgers Cancer Institute of New Jersey | New Brunswick New Jersey, United States, 08903University of New Mexico Cancer Center | Albuquerque New Mexico, United States, 87106Roswell Park Cancer Institute | Buffalo New York, United States, 14263Northwell Health NCORP | Lake Success New York, United States, 11042North Shore University Hospital | Manhasset New York, United States, 11030Long Island Jewish Medical Center | New Hyde Park New York, United States, 11040Mount Sinai Hospital | New York New York, United States, 10029Memorial Sloan Kettering Cancer Center | New York New York, United States, 10065NYP/Weill Cornell Medical Center | New York New York, United States, 10065University of Rochester | Rochester New York, United States, 14642State University of New York Upstate Medical University | Syracuse New York, United States, 13210Montefiore Medical Center-Weiler Hospital | The Bronx New York, United States, 10461Montefiore Medical Center-Wakefield Campus | The Bronx New York, United States, 10466Montefiore Medical Center - Moses Campus | The Bronx New York, United States, 10467UNC Lineberger Comprehensive Cancer Center | Chapel Hill North Carolina, United States, 27599Carolinas Medical Center/Levine Cancer Institute | Charlotte North Carolina, United States, 28203Wake Forest University Health Sciences | Winston-Salem North Carolina, United States, 27157The Jewish Hospital | Cincinnati Ohio, United States, 45236Case Western Reserve University | Cleveland Ohio, United States, 44106MetroHealth Medical Center | Cleveland Ohio, United States, 44109Ohio State University Comprehensive Cancer Center | Columbus Ohio, United States, 43210Legacy Good Samaritan Hospital and Medical Center | Portland Oregon, United States, 97210Providence Portland Medical Center | Portland Oregon, United States, 97213Oregon Health and Science University | Portland Oregon, United States, 97239Geisinger Medical Center | Danville Pennsylvania, United States, 17822Geisinger Medical Center-Cancer Center Hazleton | Hazleton Pennsylvania, United States, 18201University of Pennsylvania/Abramson Cancer Center | Philadelphia Pennsylvania, United States, 19104Fox Chase Cancer Center | Philadelphia Pennsylvania, United States, 19111West Penn Hospital | Pittsburgh Pennsylvania, United States, 15224University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh Pennsylvania, United States, 15232Geisinger Medical Group | State College Pennsylvania, United States, 16801Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre Pennsylvania, United States, 18711Saint Francis Hospital | Greenville South Carolina, United States, 29601Prisma Health Greenville Memorial Hospital | Greenville South Carolina, United States, 29605Prisma Health Cancer Institute - Eastside | Greenville South Carolina, United States, 29615Vanderbilt University/Ingram Cancer Center | Nashville Tennessee, United States, 37232Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston Texas, United States, 77030Houston Methodist Hospital | Houston Texas, United States, 77030UT MD Anderson Cancer Center | Houston Texas, United States, 77030LDS Hospital | Salt Lake City Utah, United States, 84143Central Vermont Medical Center/National Life Cancer Treatment | Berlin Corners Vermont, United States, 05602University of Vermont and State Agricultural College | Burlington Vermont, United States, 05405Virginia Oncology Associates-Hampton | Hampton Virginia, United States, 23666VCU Massey Comprehensive Cancer Center | Richmond Virginia, United States, 23298University of Washington Medical Center - Montlake | Seattle Washington, United States, 98195Saint Mary's Medical Center | Huntington West Virginia, United States, 25702Aurora Cancer Care-Glendale | Glendale Wisconsin, United States, 53212University of Wisconsin Carbone Cancer Center - University Hospital | Madison Wisconsin, United States, 53792Marshfield Medical Center-Marshfield | Marshfield Wisconsin, United States, 54449Medical College of Wisconsin | Milwaukee Wisconsin, United States, 53226Aspirus Cancer Care-Rhinelander-James Beck Cancer Center | Rhinelander Wisconsin, United States, 54501Marshfield Medical Center-Rice Lake | Rice Lake Wisconsin, United States, 54868
Investigators
Principal Investigator: Philip L McCarthy, Alliance for Clinical Trials in Oncology