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.
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.
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)
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There are 130 Locations for this study
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
Sacramento California, 95817, United States
San Diego California, 92103, United States
San Francisco California, 94115, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80222, United States
Englewood Colorado, 80113, United States
Grand Junction Colorado, 81501, United States
Greeley Colorado, 80631, United States
Lakewood Colorado, 80228, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80501, United States
Loveland Colorado, 80539, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Wheat Ridge Colorado, 80033, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Wilmington Delaware, 19805, United States
Washington District of Columbia, 20037, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Boise Idaho, 83712, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Indianapolis Indiana, 46202, United States
Kansas City Kansas, 66112, United States
Lawrence Kansas, 66044, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66210, United States
Shawnee Mission Kansas, 66204, United States
Bethesda Maryland, 20889, United States
Elkton Maryland, 21921, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Burlington Massachusetts, 01805, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Jackson Mississippi, 39216, United States
Independence Missouri, 64057, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64132, United States
Kansas City Missouri, 64154, United States
Lee's Summit Missouri, 64086, United States
Liberty Missouri, 64068, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Camden New Jersey, 08103, United States
New Brunswick New Jersey, 08903, United States
Albuquerque New Mexico, 87106, United States
Bronx New York, 10461, United States
Bronx New York, 10466, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
Lake Success New York, 11042, United States
Manhasset New York, 11030, United States
New Hyde Park New York, 11040, United States
New York New York, 10029, United States
New York New York, 10065, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28203, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45236, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Danville Pennsylvania, 17822, United States
Hazleton Pennsylvania, 18201, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15232, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Greenville South Carolina, 29601, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84143, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05405, United States
Hampton Virginia, 23666, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98195, United States
Huntington West Virginia, 25702, United States
Glendale Wisconsin, 53212, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Rhinelander Wisconsin, 54501, United States
Rice Lake Wisconsin, 54868, United States
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