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ACTIVE NOT RECRUITING

NCT00098475

PHASE3

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

452

Start Date

2004-11-03

Completion Date

2026-10-23

Last Updated

2026-08-28

Healthy Volunteers

Conditions

DS Stage I Multiple Myeloma DS Stage II Multiple Myeloma DS Stage III Multiple Myeloma

Interventions

DRUG

Dexamethasone

Given PO

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

DRUG

Lenalidomide

Given PO

DRUG

Thalidomide

Given PO

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

Locations (138)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Huntsville Hospital

Huntsville, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Saint Jude Medical Center

Fullerton, California, United States

El Camino Hospital

Mountain View, California, United States

Kaiser Permanente-Rio San Diego

San Diego, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

Danbury Hospital

Danbury, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Martin Hospital South

Stuart, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Atlanta Regional CCOP

Atlanta, Georgia, United States

Augusta Oncology Associates PC-D'Antignac

Augusta, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Atrium Health Navicent

Macon, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Northwestern University

Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Ascension Alexian Brothers - Elk Grove Village

Elk Grove Village, Illinois, United States

Edward Hines Jr VA Hospital

Hines, Illinois, United States

Midwest Center for Hematology Oncology

Joliet, Illinois, United States

Duly Health and Care Joliet

Joliet, Illinois, United States

Swedish American Hospital

Rockford, Illinois, United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Edward H Kaplan MD and Associates

Skokie, Illinois, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

IU Health Arnett Cancer Care

Lafayette, Indiana, United States

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

McFarland Clinic - Ames

Ames, Iowa, United States

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

MercyOne Waterloo Cancer Center

Waterloo, Iowa, United States

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, United States

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

HealthAlliance Hospital - Leominster

Leominster, Massachusetts, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, United States

Montana Cancer Consortium NCORP

Billings, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Nebraska Cancer Research Center

Lincoln, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Midlands Community Hospital

Papillion, Nebraska, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

The Cancer Institute of New Jersey Hamilton

Hamilton, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Virtua Memorial

Mount Holly, New Jersey, United States

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Garnet Health Medical Center

Middletown, New York, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

Mount Sinai Union Square

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Southeast Clinical Oncology Research Consortium NCORP

Winston-Salem, North Carolina, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Summa Health System - Akron Campus

Akron, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Miami Valley Hospital North

Dayton, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Saint Charles Hospital

Oregon, Ohio, United States

Firelands Regional Medical Center

Sandusky, Ohio, United States

And 38 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (138)