Can a pill after transplant keep myeloma at bay?

NCT ID NCT00114101

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

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This phase 3 trial studies whether taking lenalidomide (Revlimid) after an autologous stem cell transplant can delay the return of multiple myeloma compared to a placebo. About 460 patients with active myeloma who had a stem cell transplant are involved. The main goal is to see how long it takes for the cancer to progress.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Lenalidomide (Revlimid)
What this could lead to: If successful, this could show that taking lenalidomide after a stem cell transplant helps keep multiple myeloma from coming back for a longer time.
What could go wrong: This is a maintenance therapy, not a cure. Patients may still need ongoing treatment, and lenalidomide can cause side effects like low blood counts or blood clots.

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

460 people

The number who actually took part.

Started

Dec 2004

Expected to finish

Mar 2027

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 to 70 years

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 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)

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm Smoldering Multiple 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 Refractory multiple myeloma Smoldering multiple myeloma

Contacts and locations

Locations

AdventHealth Porter

Denver, Colorado, 80210, United States
AdventHealth Shawnee Mission

Shawnee Mission, Kansas, 66204, United States
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
Aurora Cancer Care-Glendale

Glendale, Wisconsin, 53212, United States
Banner North Colorado Medical Center

Greeley, Colorado, 80631, United States
Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, 80539, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States
Beebe Medical Center

Lewes, Delaware, 19958, United States
Boulder Community Foothills Hospital

Boulder, Colorado, 80303, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Carle BroMenn Medical Center

Normal, Illinois, 61761, United States
Carle Cancer Institute Normal

Normal, Illinois, 61761, United States
Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Centerpoint Medical Center LLC

Independence, Missouri, 64057, United States
Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, 05602, United States
Christiana Care - Union Hospital

Elkton, Maryland, 21921, United States
Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
CommonSpirit Saint Anthony Hospital Cancer Center

Lakewood, Colorado, 80228, United States
Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Eureka Hospital

Eureka, Illinois, 61530, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Group

State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States
George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States
Graham Hospital Association

Canton, Illinois, 61520, United States
Heartland Cancer Research NCORP

Decatur, Illinois, 62526, United States
Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States
Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States
Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Illinois Valley Hospital

Peru, Illinois, 61354, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, 80401, United States
Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, 60612, United States
Kewanee Hospital

Kewanee, Illinois, 61443, United States
LDS Hospital

Salt Lake City, Utah, 84143, United States
Lahey Clinic

Burlington, Massachusetts, 01805, United States
Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States
Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States
Liberty Hospital

Liberty, Missouri, 64068, United States
Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States
Longmont United Hospital

Longmont, Colorado, 80501, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Mason District Hospital

Havana, Illinois, 62644, 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
Mcdonough District Hospital

Macomb, Illinois, 61455, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Hospital

Carthage, Illinois, 62321, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Menorah Medical Center

Overland Park, Kansas, 66209, United States
Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States
MetroHealth Medical Center

Cleveland, Ohio, 44109, United States
Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States
Montefiore Medical Center-Wakefield Campus

The Bronx, New York, 10466, United States
Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States
Mount Sinai Hospital

New York, New York, 10029, United States
NYP/Weill Cornell Medical Center

New York, New York, 10065, United States
North Kansas City Hospital

Kansas City, Missouri, 64116, United States
North Shore University Hospital

Manhasset, New York, 11030, United States
North Suburban Medical Center

Thornton, Colorado, 80229, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
Northwell Health NCORP

Lake Success, New York, 11042, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554, United States
OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, 61350, United States
Pekin Hospital

Pekin, Illinois, 61554, United States
Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States
Perry Memorial Hospital

Princeton, Illinois, 61356, United States
Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States
Proctor Hospital

Peoria, Illinois, 61614, United States
Providence Medical Center

Kansas City, Kansas, 66112, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Radiation Oncology Practice Corporation - North

Kansas City, Missouri, 64154, United States
Radiation Oncology Practice Corporation South

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

Overland Park, Kansas, 66210, United States
Research Medical Center

Kansas City, Missouri, 64132, United States
Rose Medical Center

Denver, Colorado, 80220, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
Saint Francis Hospital

Greenville, South Carolina, 29601, United States
Saint Francis Hospital - Wilmington

Wilmington, Delaware, 19805, United States
Saint Joseph Health Center

Kansas City, Missouri, 64114, United States
Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, 80218, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States
Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
Saint Margaret's Hospital

Spring Valley, Illinois, 61362, United States
Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States
Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States
Saint Mary's Medical Center

Huntington, West Virginia, 25702, United States
Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Swedish Medical Center

Englewood, Colorado, 80113, United States
The Jewish Hospital

Cincinnati, Ohio, 45236, United States
The Medical Center of Aurora

Aurora, Colorado, 80012, United States
UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States
UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States
UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
University Health Truman Medical Center

Kansas City, Missouri, 64108, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center

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

Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, 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
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Virginia Oncology Associates-Hampton

Hampton, Virginia, 23666, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States
Western States Cancer Research NCORP

Denver, Colorado, 80222, United States

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