Multiple Myeloma Clinical Trial

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

Summary

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.

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Full Description

PRIMARY OBJECTIVE:

I. To evaluate the response rate and toxicity of lenalidomide (CC-5013) 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, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 cycles 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, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 cycles 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.

View Eligibility Criteria

Eligibility Criteria

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

Exclusion Criteria:

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
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
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; due to the potential teratogenic properties of CC 5013, and the known teratogenicity associated with thalidomide, the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

452

Study ID:

NCT00098475

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 136 Locations for this study

See Locations Near You

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
SCL Health 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 Health Science Center - Gainesville
Gainesville Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Martin Hospital South
Stuart Florida, 34997, United States
Phoebe Putney Memorial Hospital
Albany Georgia, 31701, United States
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Atlanta Regional CCOP
Atlanta Georgia, 30342, United States
Augusta Oncology Associates PC-D'Antignac
Augusta Georgia, 30901, United States
Dekalb Medical Center
Decatur Georgia, 30033, United States
Medical Center of Central Georgia
Macon Georgia, 31201, 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 Cancer Institute - Boise
Boise Idaho, 83712, United States
Saint Anthony's Health
Alton Illinois, 62002, United States
Northwestern University
Chicago Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago Illinois, 60612, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Ascension Alexian Brothers - Elk Grove Village
Elk Grove Village Illinois, 60007, United States
Edward Hines Jr VA Hospital
Hines Illinois, 60141, United States
Midwest Center for Hematology Oncology
Joliet Illinois, 60432, United States
Duly Health and Care Joliet
Joliet Illinois, 60435, 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
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Franciscan Health Indianapolis
Indianapolis Indiana, 46237, 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 - Ames
Ames Iowa, 50010, United States
University of Iowa Healthcare Cancer Services 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
MercyOne Waterloo Medical Center
Waterloo Iowa, 50702, United States
Kansas City NCI Community Oncology Research Program
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
Ascension Saint John Hospital
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 in Rochester
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 NCORP
Billings Montana, 59102, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Nebraska Cancer Research Center
Lincoln Nebraska, 68510, United States
Nebraska Methodist Hospital
Omaha Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Midlands Community Hospital
Papillion Nebraska, 68046, United States
Hackensack University Medical Center
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
Virtua Memorial
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
Garnet Health Medical Center
Middletown New York, 10940, United States
NYU Winthrop Hospital
Mineola New York, 11501, United States
Mount Sinai Union Square
New York New York, 10003, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
Mission Hospital
Asheville North Carolina, 28801, United States
Wayne Memorial Hospital
Goldsboro North Carolina, 27534, United States
Southeast Clinical Oncology Research Consortium 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 Broadway Medical Center
Fargo North Dakota, 58122, United States
Summa Health System - Akron Campus
Akron Ohio, 44304, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Miami Valley Hospital
Dayton Ohio, 45409, United States
Miami Valley Hospital North
Dayton Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin Ohio, 45005, 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
ProMedica Flower Hospital
Sylvania Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin Ohio, 44883, United States
Toledo Community Hospital Oncology Program CCOP
Toledo Ohio, 43617, United States
Toledo Clinic Cancer Centers-Toledo
Toledo Ohio, 43623, United States
Kaiser Permanente Northwest
Portland Oregon, 97227, United States
Jefferson Abington Hospital
Abington Pennsylvania, 19001, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17602, United States
Saint Mary Medical and Regional Cancer Center
Langhorne Pennsylvania, 19047, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Chestnut Hill Health System
Philadelphia Pennsylvania, 19118, United States
Einstein Medical Center Philadelphia
Philadelphia Pennsylvania, 19141, 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, 17403, 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
Sentara Martha Jefferson Hospital
Charlottesville Virginia, 22901, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg Virginia, 24501, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States
West Virginia University Healthcare
Morgantown West Virginia, 26506, United States
ThedaCare Regional Cancer Center
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 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
ProHealth Oconomowoc Memorial Hospital
Oconomowoc Wisconsin, 53066, United States
ProHealth Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

452

Study ID:

NCT00098475

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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