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Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With 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

Intervention: Dexamethasone (Drug); Laboratory Biomarker Analysis (Other); Lenalidomide (Drug); Thalidomide (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
S. Rajkumar, Principal Investigator, Affiliation: ECOG-ACRIN Cancer Research Group


This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Clinical Details

Official title: A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-responders

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

Primary outcome: Proportion of Patients With Objective Response (First Phase, Step 1)

Secondary outcome: Proportion of Patients With Objective Response (First Phase, Step 2)

Detailed description: PRIMARY OBJECTIVES: I. To evaluate the response rate and toxicity of CC-5013 (lenalidomide) plus dexamethasone (standard dose) versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity (First Phase). SECONDARY OBJECTIVES: I. To evaluate the response rate of thalidomide plus dexamethasone (Thal/Dex) in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms (First Phase). II. To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade, on plasma cell labeling index (PCLI), and on the expression of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the marrow (First Phase). III. To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells (MPCs) (First Phase). IV. To evaluate in a separate expansion phase the efficacy of aspirin (325 mg/day) versus Coumadin (dose adjusted to maintain a target international normalized ratio [INR] of 2-3) in preventing deep vein thrombosis (DVT) in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20. Arm II: Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22. In both arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 courses of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively. Arm III (patients with no response after treatment on Arm I): Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20. Arm IV (patients with no response after treatment on Arm II): Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22. In both salvage therapy arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 courses of therapy, patients may undergo stem cell harvest (using growth factors only) for cryopreservation. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients must be diagnosed with symptomatic multiple myeloma within the past 90 days

confirmed by the following:

- Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or

biopsy proven plasmacytoma which must be obtained within 4 weeks prior to randomization

- Measurable levels of monoclonal protein (M protein): >= 1. 0 g/dL on serum

protein electrophoresis or >= 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization; both serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) are required to be performed within 28 days prior to randomization; please note that if both serum and urine m-components are present, both must be followed in order to evaluate response

- Hemoglobin > 7 g/dL

- Platelet count > 75,000 cells/mm^3

- Absolute neutrophil count > 1000 cells/mm^3

- Creatinine < 2. 5 mg/dL and creatinine clearance (measured or calculated) >= 60 mL/min

- Bilirubin =< 1. 5 mg/dL

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and

serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2. 5 times the upper limit of normal

- No prior systemic therapy with the exception of bisphosphonates for multiple myeloma

- Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not

permitted; prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day; prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted

- Prior palliative and/or localized radiation therapy is permitted provided at least 4

weeks have passed from date of last radiation therapy to date of registration; patients with prior solitary plasmacytoma treated with radiation therapy with curative intent are eligible if the disease has now progressed to active multiple myeloma meeting all the eligibility criteria for this protocol

- Patients must not have active, uncontrolled seizure disorder; patients must have had

no seizures in the last 6 months

- Patients must not have uncontrolled intercurrent illness including uncontrolled

hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

- Patients with smoldering myeloma or monoclonal gammopathy of undetermined

significance are not eligible

- Patients must not have grade 2 or higher peripheral neuropathy due to other medical

conditions at the time of randomization

- Patients must not have active, uncontrolled infection

- Patients must not have a history of current or previous deep vein thrombosis or

pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy

- For patients registered prior to activation of Addendum # 6; patients must be

willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or Coumadin

- For patients registered after activation of Addendum # 6; patients entering the

expansion phase of the protocol, which tests anticoagulant prophylaxis, must be able and willing to be randomized between aspirin at 325 mg/day and Coumadin

- Female patients MUST NOT be pregnant or breastfeeding

- Females of childbearing potential (FCBP) must have a negative serum or urine

pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method (intrauterine device [IUD], birth control pills, tubal ligation or partner's vasectomy) and one additional effective method (condom, diaphragm or cervical cap); FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy starting 4 weeks prior to and while taking CC5013 or thalidomide and for four weeks after discontinuing this therapy; a FCBP is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i. e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure

- Patients with a history of prior malignancy are eligible provided there is no active

malignancy and a low expectation of recurrence within 6 months

Locations and Contacts

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233, United States

Huntsville Hospital, Huntsville, Alabama 35801, United States

Providence Alaska Medical Center, Anchorage, Alaska 99508, United States

Mayo Clinic in Arizona, Scottsdale, Arizona 85259, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California 91505, United States

Saint Jude Medical Center, Fullerton, California 92835, United States

El Camino Hospital, Mountain View, California 94040, United States

Kaiser Permanente-San Diego Mission, San Diego, California 92108, United States

The Medical Center of Aurora, Aurora, Colorado 80012, United States

Penrose-Saint Francis Healthcare, Colorado Springs, Colorado 80907, United States

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

Swedish Medical Center, Englewood, Colorado 80113, United States

Poudre Valley Hospital, Fort Collins, Colorado 80524, United States

McKee Medical Center, Loveland, Colorado 80539, United States

Danbury Hospital, Danbury, Connecticut 06810, United States

Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut 06360, United States

Holy Cross Hospital, Fort Lauderdale, Florida 33308, United States

University of Florida, Gainesville, Florida 32610, United States

Baptist Cancer Institute, Jacksonville, Florida 32207, United States

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

Martin Hospital South, Stuart, Florida 34997, United States

Phoebe Putney Memorial Hospital, Albany, Georgia 31701, United States

Atlanta Regional CCOP, Atlanta, Georgia 30342, United States

Emory University/Winship Cancer Institute, Atlanta, Georgia 30322, United States

Augusta Oncology Associates PC-Saint Sebastian, Augusta, Georgia 30901, United States

Dekalb Medical Center, Decatur, Georgia 30033, United States

Medical Center of Central Georgia, Macon, Georgia 31208, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia 31405, United States

University of Hawaii Cancer Center, Honolulu, Hawaii 96813, United States

Saint Luke's Mountain States Tumor Institute, Boise, Idaho 83712, United States

Saint Anthony's Health, Alton, Illinois 62002, United States

John H Stroger Jr Hospital of Cook County, Chicago, Illinois 60612-3785, United States

Northwestern University, Chicago, Illinois 60611, United States

Decatur Memorial Hospital, Decatur, Illinois 62526, United States

Alexian Brothers Medical and Cancer Center, Elk Grove Village, Illinois 60007, United States

Hines Veterans Administration Hospital, Hines, Illinois 60141, United States

Joliet Oncology-Hematology Associates Limited, Joliet, Illinois 60435, United States

Midwest Center for Hematology Oncology, Joliet, Illinois 60432, United States

Swedish American Hospital, Rockford, Illinois 61104, United States

SwedishAmerican Regional Cancer Center/ACT, Rockford, Illinois 61114, United States

Edward H Kaplan MD and Associates, Skokie, Illinois 60076, United States

Elkhart General Hospital, Elkhart, Indiana 46515, United States

Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana 46845, United States

Franciscan Saint Francis Health-Indianapolis, Indianapolis, Indiana 46237, United States

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202, United States

IU Health Arnett Cancer Care, Lafayette, Indiana 47904, United States

Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana 46545, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa 50010, United States

Hematology Oncology Associates-Quad Cities, Bettendorf, Iowa 52722, United States

Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

Siouxland Regional Cancer Center, Sioux City, Iowa 51101, United States

Covenant Medical Center, Waterloo, Iowa 50702, United States

Kansas City CCOP, Prairie Village, Kansas 66208, United States

Harold Alfond Center for Cancer Care, Augusta, Maine 04330, United States

Greater Baltimore Medical Center, Baltimore, Maryland 21204, United States

HealthAlliance Hospital - Leominster, Leominster, Massachusetts 01453, United States

Saint John Hospital and Medical Center, Detroit, Michigan 48236, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States

Mercy Hospital, Coon Rapids, Minnesota 55433, United States

Fairview-Southdale Hospital, Edina, Minnesota 55435, United States

Unity Hospital, Fridley, Minnesota 55432, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota 55109, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Regions Hospital, Saint Paul, Minnesota 55101, United States

United Hospital, Saint Paul, Minnesota 55102, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri 63141, United States

Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri 63141, United States

Montana Cancer Consortium CCOP, Billings, Montana 59101, United States

Great Falls Clinic, Great Falls, Montana 59405, United States

Nebraska Cancer Research Center, Lincoln, Nebraska 68510, United States

Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States

Alegent Health Immanuel Medical Center, Omaha, Nebraska 68122, United States

Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States

Midlands Community Hospital, Papillion, Nebraska 68046, United States

Hackensack University Medical CCOP, Hackensack, New Jersey 07601, United States

The Cancer Institute of New Jersey Hamilton, Hamilton, New Jersey 08690, United States

Morristown Medical Center, Morristown, New Jersey 07960, United States

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County, Mount Holly, New Jersey 08060, United States

Jersey Shore Medical Center, Neptune, New Jersey 07753, United States

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

Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey 08876, United States

Orange Regional Medical Center, Middletown, New York 10940, United States

Winthrop University Hospital, Mineola, New York 11501, United States

Beth Israel Medical Center, New York, New York 10003, United States

Stony Brook University Medical Center, Stony Brook, New York 11794, United States

Mission Hospital-Memorial Campus, Asheville, North Carolina 28801, United States

Wayne Memorial Hospital, Goldsboro, North Carolina 27534, United States

Southeast Cancer Consortium-Upstate NCORP, Winston-Salem, North Carolina 27104, United States

Sanford Bismarck Medical Center, Bismarck, North Dakota 58501, United States

Essentia Health Cancer Center-South University Clinic, Fargo, North Dakota 58103, United States

Sanford Medical Center-Fargo, Fargo, North Dakota 58122, United States

Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio 44304, United States

MetroHealth Medical Center, Cleveland, Ohio 44109, United States

Miami Valley Hospital, Dayton, Ohio 45409, United States

Samaritan North Health Center, Dayton, Ohio 45415, United States

Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio 45005-1066, United States

Kettering Medical Center, Kettering, Ohio 45429, United States

Saint Charles Hospital, Oregon, Ohio 43616, United States

Firelands Regional Medical Center, Sandusky, Ohio 44870, United States

Flower Hospital, Sylvania, Ohio 43560, United States

Mercy Hospital of Tiffin, Tiffin, Ohio 44883, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio 43623, United States

Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio 43617, United States

Kaiser Permanente, Portland, Oregon 97227, United States

Abington Memorial Hospital, Abington, Pennsylvania 19001, United States

Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Lancaster General Hospital, Lancaster, Pennsylvania 17604, United States

Saint Mary Medical and Regional Cancer Center, Langhorne, Pennsylvania 19047, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States

Chestnut Hill Health System, Philadelphia, Pennsylvania 19118, United States

ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania 19103, United States

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

Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, United States

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

Guthrie Medical Group PC-Robert Packer Hospital, Sayre, Pennsylvania 18840, United States

Grand View Hospital, Sellersville, Pennsylvania 18960, United States

Mount Nittany Medical Center, State College, Pennsylvania 16803, United States

Reading Hospital, West Reading, Pennsylvania 19611, United States

Lankenau Medical Center, Wynnewood, Pennsylvania 19096, United States

WellSpan Health-York Hospital, York, Pennsylvania 17405, United States

McLeod Regional Medical Center, Florence, South Carolina 29506, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57701, United States

Sanford Cancer Center-Oncology Clinic, Sioux Falls, South Dakota 57104, United States

Martha Jefferson Hospital, Charlottesville, Virginia 22901, United States

University of Virginia Cancer Center, Charlottesville, Virginia 22908, United States

Lynchburg Hematology-Oncology Clinic, Lynchburg, Virginia 24501, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia 23298, United States

Swedish Medical Center-First Hill, Seattle, Washington 98122-4307, United States

West Virginia University Healthcare, Morgantown, West Virginia 26506, United States

Fox Valley Hematology and Oncology, Appleton, Wisconsin 54911, United States

Gundersen Lutheran Medical Center, La Crosse, Wisconsin 54601, United States

Dean Hematology and Oncology Clinic, Madison, Wisconsin 53717, 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

Oconomowoc Memorial Hospital-ProHealth Care Inc, Oconomowoc, Wisconsin 53066, United States

Waukesha Memorial Hospital, Waukesha, Wisconsin 53188, United States

Additional Information

Starting date: October 2004
Last updated: August 4, 2015

Page last updated: August 23, 2015

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