New combo shows promise in myeloma battle

NCT ID NCT00098475

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tested two different doses of dexamethasone combined with lenalidomide in 452 people newly diagnosed with multiple myeloma. The goal was to see which dose worked better at shrinking tumors. If the first treatment didn't work, patients could switch to a thalidomide-based backup. The study found that both combinations helped control the cancer, but patients need ongoing treatment to manage the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

452 people

The number who actually took part.

Started

Nov 2004

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma smoldering plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DS stage I multiple myeloma DS stage II multiple myeloma DS stage III multiple myeloma

Contacts and locations

Locations

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States
Alegent Health Immanuel Medical Center

Omaha, Nebraska, 68122, United States
Ascension Alexian Brothers - Elk Grove Village

Elk Grove Village, Illinois, 60007, United States
Atlanta Regional CCOP

Atlanta, Georgia, 30342, United States
Atrium Health Navicent

Macon, Georgia, 31201, United States
Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States
Augusta Oncology Associates PC-D'Antignac

Augusta, Georgia, 30901, United States
Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, 80539, United States
Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
Centra Alan B Pearson Regional Cancer Center

Lynchburg, Virginia, 24501, United States
Danbury Hospital

Danbury, Connecticut, 06810, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Duly Health and Care Joliet

Joliet, Illinois, 60435, United States
Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States
Edward H Kaplan MD and Associates

Skokie, Illinois, 60076, United States
Edward Hines Jr VA Hospital

Hines, Illinois, 60141, United States
Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, 19141, United States
El Camino Hospital

Mountain View, California, 94040, United States
Elkhart General Hospital

Elkhart, Indiana, 46515, United States
Emory Decatur Hospital

Decatur, Georgia, 30033, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103, United States
Fairview Southdale Hospital

Edina, Minnesota, 55435, United States
Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, 46845, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States
Garnet Health Medical Center

Middletown, New York, 10940, United States
Grand View Hospital

Sellersville, Pennsylvania, 18960, United States
Great Falls Clinic

Great Falls, Montana, 59405, United States
Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Harold Alfond Center for Cancer Care

Augusta, Maine, 04330, United States
HealthAlliance Hospital - Leominster

Leominster, Massachusetts, 01453, United States
Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States
Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States
Huntsville Hospital

Huntsville, Alabama, 35801, United States
IU Health Arnett Cancer Care

Lafayette, Indiana, 47904, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Jefferson Abington Hospital

Abington, Pennsylvania, 19001, United States
Jersey Shore Medical Center

Neptune City, New Jersey, 07753, United States
John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States
Kaiser Permanente Northwest

Portland, Oregon, 97227, United States
Kaiser Permanente-Rio San Diego

San Diego, California, 92108, United States
Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, 66208, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States
Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Martin Hospital South

Stuart, Florida, 34997, United States
Mayo Clinic in Arizona

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

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

Rochester, Minnesota, 55905, United States
McFarland Clinic - Ames

Ames, Iowa, 50010, United States
McLeod Regional Medical Center

Florence, South Carolina, 29506, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States
MercyOne Waterloo Cancer Center

Waterloo, Iowa, 50702, 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
Midlands Community Hospital

Papillion, Nebraska, 68046, United States
Midwest Center for Hematology Oncology

Joliet, Illinois, 60432, United States
Mission Hospital

Asheville, North Carolina, 28801, United States
Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States
Morristown Medical Center

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

State College, Pennsylvania, 16803, United States
Mount Sinai Union Square

New York, New York, 10003, United States
NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States
Nebraska Cancer Research Center

Lincoln, Nebraska, 68510, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
Northwestern University

Chicago, Illinois, 60611, United States
OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States
Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States
Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States
Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States
ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States
ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States
ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States
Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States
Rapid City Regional Hospital

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

West Reading, Pennsylvania, 19611, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
SSM Health Dean Medical Group - South Madison Campus

Madison, Wisconsin, 53715, United States
Saint Charles Hospital

Oregon, Ohio, 43616, United States
Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States
Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, 80218, United States
Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, 46545, United States
Saint Jude Medical Center

Fullerton, California, 92835, United States
Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, 63141, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Mary Medical and Regional Cancer Center

Langhorne, Pennsylvania, 19047, United States
Sanford Bismarck Medical Center

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

Fargo, North Dakota, 58122, United States
Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Sentara Martha Jefferson Hospital

Charlottesville, Virginia, 22911, United States
Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States
Southeast Clinical Oncology Research Consortium NCORP

Winston-Salem, North Carolina, 27104, United States
Stony Brook University Medical Center

Stony Brook, New York, 11794, United States
Summa Health System - Akron Campus

Akron, Ohio, 44304, United States
Swedish American Hospital

Rockford, Illinois, 61104, United States
Swedish Medical Center

Englewood, Colorado, 80113, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
Temple Health - Chestnut Hill Hospital

Philadelphia, Pennsylvania, 19118, United States
The Cancer Institute of New Jersey Hamilton

Hamilton, New Jersey, 08690, United States
The Medical Center of Aurora

Aurora, Colorado, 80012, United States
ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States
Toledo Community Hospital Oncology Program CCOP

Toledo, Ohio, 43617, United States
UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States
UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114, United States
United Hospital

Saint Paul, Minnesota, 55102, United States
Unity Hospital

Fridley, Minnesota, 55432, United States
University of Alabama at Birmingham Cancer Center

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

Honolulu, Hawaii, 96813, United States
University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, 52722, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States
Virtua Memorial

Mount Holly, New Jersey, 08060, United States
Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States
WellSpan Health-York Hospital

York, Pennsylvania, 17403, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

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