DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: DS Stage I Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma; Smoldering Plasma Cell Myeloma

Intervention: Autologous Hematopoietic Stem Cell Transplantation (Procedure); Laboratory Biomarker Analysis (Other); Lenalidomide (Drug); Melphalan (Drug); Peripheral Blood Stem Cell Transplantation (Procedure); Placebo (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Philip McCarthy, Principal Investigator, Affiliation: Alliance for Clinical Trials in Oncology

Summary

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients who are undergoing autologous stem cell transplant for multiple myeloma. 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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to Progression

Secondary outcome: Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100

Detailed description: PRIMARY OBJECTIVES: 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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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)

Locations and Contacts

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

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

Colorado Cancer Research Program CCOP, Denver, Colorado 80224-2522, United States

Exempla Saint Joseph Hospital, Denver, Colorado 80218, United States

Porter Adventist Hospital, Denver, Colorado 80210, United States

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado 80218, United States

Rose Medical Center, Denver, Colorado 80220, United States

Swedish Medical Center, Englewood, Colorado 80113, United States

Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado 81502, 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

Exempla Lutheran Medical Center, Wheat Ridge, Colorado 80033, 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, Gainesville, Florida 32610, United States

Mayo Clinic in Florida, Jacksonville, Florida 32224-9980, United States

Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia 30342, United States

Georgia Regents University Medical Center, Augusta, Georgia 30912, 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 Chicago Comprehensive Cancer Center, Chicago, Illinois 60637, United States

University of Illinois, Chicago, Illinois 60612, 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

Community Cancer Center Foundation, 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

Pekin Cancer Treatment Center, Pekin, Illinois 61554, United States

Pekin Hospital, Pekin, Illinois 61554, United States

Illinois CancerCare-Peoria, Peoria, Illinois 61615, United States

Illinois Oncology Research Association CCOP, Peoria, Illinois 61615, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61603, United States

OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States

Proctor Hospital, Peoria, Illinois 61614, 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

Radiation Oncology Practice Corporation Southwest, Overland Park, Kansas 66210, United States

Walter Reed National Military Medical Center, Bethesda, Maryland 20889-5600, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota 55455, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States

Centerpoint Medical Center LLC, Independence, Missouri 64057, United States

Radiation Oncology Practice Corporation - North, Kansas City, Missouri 64154, United States

Radiation Oncology Practice Corporation South, Kansas City, Missouri 64114, United States

Saint Luke's Cancer Institute, Kansas City, Missouri 64111, United States

Liberty Radiation Oncology Center, Liberty, Missouri 64068, United States

Washington University School of Medicine, Saint Louis, Missouri 63110, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, United States

Albert Einstein College of Medicine, Bronx, New York 10461, United States

Montefiore Medical Center - Moses Campus, Bronx, New York 10467-2490, United States

Montefiore Medical Center-Wakefield Campus, Bronx, New York 10466, United States

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

North Shore University Hospital, Manhasset, New York 11030, United States

North Shore-LIJ Health System NCORP, Manhasset, New York 11030, United States

Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States

Mount Sinai Medical Center, New York, New York 10029, United States

Weill Medical College of Cornell University, 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

University of North Carolina at Chapel Hill, 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

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

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania 15232, United States

West Penn Hospital, Pittsburgh, Pennsylvania 15224, United States

Geisinger Medical Group, State College, Pennsylvania 16801, United States

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania 18711, United States

Greenville Memorial Hospital, Greenville, South Carolina 29605, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee 37232, 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 College of Medicine, Burlington, Vermont 05405, United States

University of Washington Medical Center, Seattle, Washington 98195, United States

Saint Mary's Medical Center, Huntington, West Virginia 25702, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53792, United States

Marshfield Clinic, Marshfield, Wisconsin 54449, United States

Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Marshfield Clinic at James Beck Cancer Center, Rhinelander, Wisconsin 54501, United States

Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin 54868, United States

Additional Information

Starting date: December 2004
Last updated: July 29, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017