NCT00114101Active, not recruitingPhase 3
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 460 (actual)
- First submitted
- 13 Jun 2005
- Start date
- 15 Dec 2004
- Primary completion date
- 31 Dec 2012
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Multiple myeloma
- NCT number
- NCT00114101
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 460
- From 15 Dec 2004 to the primary completion date, 31 Dec 2012
- 140 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (140)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Northside Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| The Medical Center of Aurora Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Central Vermont Medical Center/National Life Cancer Treatment Coordinator of this site? Confirm its status | Berlin Corners | United States | Unknown status |
| Walter Reed National Military Medical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| OSF Saint Joseph Medical Center Coordinator of this site? Confirm its status | Bloomington | United States | Unknown status |
| Saint Luke's Cancer Institute - Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Boulder Community Foothills Hospital Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Vermont and State Agricultural College Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Lahey Clinic Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Cooper Hospital University Medical Center Coordinator of this site? Confirm its status | Camden | United States | Unknown status |
| Graham Hospital Association Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Memorial Hospital Coordinator of this site? Confirm its status | Carthage | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Jesse Brown Veterans Affairs Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The Jewish Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| MetroHealth Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Penrose-Saint Francis Healthcare Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Heartland Cancer Research NCORP Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Rose Medical Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| AdventHealth Porter Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Western States Cancer Research NCORP Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Saint Joseph Hospital - Cancer Centers of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Presbyterian - Saint Lukes Medical Center - Health One Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Christiana Care - Union Hospital Coordinator of this site? Confirm its status | Elkton | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Eureka Hospital Coordinator of this site? Confirm its status | Eureka | United States | Unknown status |
| UF Health Cancer Institute - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Illinois CancerCare-Galesburg Coordinator of this site? Confirm its status | Galesburg | United States | Unknown status |
| Galesburg Cottage Hospital Coordinator of this site? Confirm its status | Galesburg | United States | Unknown status |
| Aurora Cancer Care-Glendale Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Saint Mary's Hospital and Regional Medical Center Coordinator of this site? Confirm its status | Grand Junction | United States | Unknown status |
| Banner North Colorado Medical Center Coordinator of this site? Confirm its status | Greeley | United States | Unknown status |
| Saint Francis Hospital Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Prisma Health Greenville Memorial Hospital Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Prisma Health Cancer Institute - Eastside Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Virginia Oncology Associates-Hampton Coordinator of this site? Confirm its status | Hampton | United States | Unknown status |
| Mason District Hospital Coordinator of this site? Confirm its status | Havana | United States | Unknown status |
| Geisinger Medical Center-Cancer Center Hazleton Coordinator of this site? Confirm its status | Hazleton | United States | Unknown status |
| Hopedale Medical Complex - Hospital Coordinator of this site? Confirm its status | Hopedale | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UT MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Saint Mary's Medical Center Coordinator of this site? Confirm its status | Huntington | United States | Unknown status |
| Centerpoint Medical Center LLC Coordinator of this site? Confirm its status | Independence | United States | Unknown status |
| Indiana University/Melvin and Bren Simon Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Radiation Oncology Practice Corporation South Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Saint Joseph Health Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Providence Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Research Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University Health Truman Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| North Kansas City Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Radiation Oncology Practice Corporation - North Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Kewanee Hospital Coordinator of this site? Confirm its status | Kewanee | United States | Unknown status |
| Northwell Health NCORP Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| CommonSpirit Saint Anthony Hospital Cancer Center Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Lawrence Memorial Hospital Coordinator of this site? Confirm its status | Lawrence | United States | Unknown status |
| Saint Luke's East - Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Unknown status |
| Beebe Medical Center Coordinator of this site? Confirm its status | Lewes | United States | Unknown status |
| Liberty Hospital Coordinator of this site? Confirm its status | Liberty | United States | Unknown status |
| Sky Ridge Medical Center Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
| Longmont United Hospital Coordinator of this site? Confirm its status | Longmont | United States | Unknown status |
| Banner North Colorado Medical Center - Loveland Campus Coordinator of this site? Confirm its status | Loveland | United States | Unknown status |
| Mcdonough District Hospital Coordinator of this site? Confirm its status | Macomb | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Christiana Care Health System-Christiana Hospital Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Carle BroMenn Medical Center Coordinator of this site? Confirm its status | Normal | United States | Unknown status |
| Carle Cancer Institute Normal Coordinator of this site? Confirm its status | Normal | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Ottawa Regional Hospital and Healthcare Center Coordinator of this site? Confirm its status | Ottawa | United States | Unknown status |
| Illinois CancerCare-Ottawa Clinic Coordinator of this site? Confirm its status | Ottawa | United States | Unknown status |
| Menorah Medical Center Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Radiation Oncology Practice Corporation Southwest Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| OSF Saint Francis Radiation Oncology at Pekin Coordinator of this site? Confirm its status | Pekin | United States | Unknown status |
| Pekin Hospital Coordinator of this site? Confirm its status | Pekin | United States | Unknown status |
| Proctor Hospital Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Methodist Medical Center of Illinois Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Illinois CancerCare-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Illinois Valley Hospital Coordinator of this site? Confirm its status | Peru | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| West Penn Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Legacy Good Samaritan Hospital and Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Perry Memorial Hospital Coordinator of this site? Confirm its status | Princeton | United States | Unknown status |
| Saint Mary Corwin Medical Center Coordinator of this site? Confirm its status | Pueblo | United States | Unknown status |
| Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Coordinator of this site? Confirm its status | Rhinelander | United States | Unknown status |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Unknown status |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Heartland Regional Medical Center Coordinator of this site? Confirm its status | Saint Joseph | United States | Unknown status |
| LDS Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UC San Diego Medical Center - Hillcrest Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| UCSF Medical Center-Mount Zion Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| AdventHealth Shawnee Mission Coordinator of this site? Confirm its status | Shawnee Mission | United States | Unknown status |
| Saint Margaret's Hospital Coordinator of this site? Confirm its status | Spring Valley | United States | Unknown status |
| Geisinger Medical Group Coordinator of this site? Confirm its status | State College | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center-Wakefield Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center-Weiler Hospital Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| North Suburban Medical Center Coordinator of this site? Confirm its status | Thornton | United States | Unknown status |
| George Washington University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Intermountain Health Lutheran Hospital Coordinator of this site? Confirm its status | Wheat Ridge | United States | Unknown status |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Unknown status |
| Saint Francis Hospital - Wilmington Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.