Multiple Myeloma Clinical Trial

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

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility 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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

460

Study ID:

NCT00114101

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 130 Locations for this study

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Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
UC San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
UCSF Medical Center-Mount Zion
San Francisco California, 94115, United States
The Medical Center of Aurora
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs Colorado, 80907, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
Western States Cancer Research NCORP
Denver Colorado, 80222, United States
Swedish Medical Center
Englewood Colorado, 80113, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction Colorado, 81501, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
Saint Anthony Hospital
Lakewood Colorado, 80228, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Longmont United Hospital
Longmont Colorado, 80501, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Saint Mary Corwin Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
SCL Health Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Saint Francis Hospital - Wilmington
Wilmington Delaware, 19805, United States
George Washington University Medical Center
Washington District of Columbia, 20037, United States
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Augusta University Medical Center
Augusta Georgia, 30912, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Saint Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital Association
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Jesse Brown Veterans Affairs Medical Center
Chicago Illinois, 60612, United States
University of Illinois
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Heartland Cancer Research NCORP
Decatur Illinois, 62526, United States
Eureka Hospital
Eureka Illinois, 61530, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale Illinois, 61747, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
Mcdonough District Hospital
Macomb Illinois, 61455, United States
Bromenn Regional Medical Center
Normal Illinois, 61761, United States
Carle Cancer Institute Normal
Normal Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa Illinois, 61350, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin Illinois, 61554, United States
Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
Saint Margaret's Hospital
Spring Valley Illinois, 61362, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Providence Medical Center
Kansas City Kansas, 66112, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Radiation Oncology Practice Corporation Southwest
Overland Park Kansas, 66210, United States
Advent Health - Shawnee Mission Medical Center
Shawnee Mission Kansas, 66204, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Christiana Care - Union Hospital
Elkton Maryland, 21921, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington Massachusetts, 01805, United States
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Centerpoint Medical Center LLC
Independence Missouri, 64057, United States
Truman Medical Centers
Kansas City Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Radiation Oncology Practice Corporation South
Kansas City Missouri, 64114, United States
Saint Joseph Health Center
Kansas City Missouri, 64114, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Radiation Oncology Practice Corporation - North
Kansas City Missouri, 64154, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Radiation Oncology Center
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Montefiore Medical Center-Weiler Hospital
Bronx New York, 10461, United States
Montefiore Medical Center-Wakefield Campus
Bronx New York, 10466, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Northwell Health NCORP
Lake Success New York, 11042, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Mount Sinai Hospital
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
NYP/Weill Cornell Medical Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
The Jewish Hospital
Cincinnati Ohio, 45236, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Legacy Good Samaritan Hospital and Medical Center
Portland Oregon, 97210, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton Pennsylvania, 18201, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh Pennsylvania, 15232, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States
Saint Francis Hospital
Greenville South Carolina, 29601, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
LDS Hospital
Salt Lake City Utah, 84143, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington Vermont, 05405, United States
Virginia Oncology Associates-Hampton
Hampton Virginia, 23666, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States
Saint Mary's Medical Center
Huntington West Virginia, 25702, United States
Aurora Cancer Care-Glendale
Glendale Wisconsin, 53212, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Ascension Saint Mary's Hospital
Rhinelander Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake Wisconsin, 54868, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

460

Study ID:

NCT00114101

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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