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ACTIVE NOT RECRUITING

NCT00602641

PHASE3

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.

Official title: An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

306

Start Date

2008-02-29

Completion Date

2026-02-22

Last Updated

2026-03-03

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

DRUG

Lenalidomide

Given PO

DRUG

Melphalan

Given PO

DRUG

Prednisone

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Thalidomide

Given PO

Inclusion Criteria: * Patients must have a confirmed diagnosis of symptomatic myeloma; for the original diagnosis of myeloma patients should have met the following criteria at one point in their disease course: * Bone marrow plasmacytosis with \>= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma * Patient must have had symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis namely; at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction * NOTE: Patients with asymptomatic smoldering myeloma (serum m protein \>= 3 gm/dL or bone marrow plasma cells \>= 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein \< 3 gm/dL and bone marrow plasma cells \< 10% plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible * Patients must be \> 65 and have declined alternative treatment OR patients who are \>= 18 \< 65 are eligible if they: * Are not a candidate for autologous stem cell transplantation in the opinion of the treating physician OR * Have declined transplant or other alternative treatment * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * All tests below must be performed within 28 days prior to randomization: * Serum free light chain assay * Kappa free light chain * Lambda free light chain * NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine; measurable disease in the serum is defined as having a serum M-spike \>= 1 g/dL; measurable disease in the urine is defined as having a urine M-spike \>= 200 mg/24 hr * NOTE: urine protein electrophoresis (UPEP) (on a 24 hour collection) is required, no substitute method is acceptable; urine must be followed monthly if the baseline urine M-spike is \>= 200 mg/24 hr; 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 * Total 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 * Patients must be previously untreated for myeloma, although prior treatment for myeloma with prednisone or dexamethasone for less than 4 weeks total dosing alone or in combination with thalidomide or lenalidomide for less than 2 weeks total dosing is allowable * Patients may be receiving bisphosphonates or growth factors (erythropoietin) for multiple myeloma; although erythropoietin is allowed, it is strongly discouraged due to increased risk of thrombosis when employed alongside thalidomide and/or lenalidomide therapy * 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 * 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 and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; 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; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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 must not have uncontrolled inter-current illness that would limit compliance with the study including: * Uncontrolled hypertension * Symptomatic congestive heart failure * Unstable angina * Uncontrolled cardiac arrhythmia * Uncontrolled psychiatric illness or social situation * Prior history of Stevens Johnson syndrome * Patients must not have grade 2 or higher peripheral neuropathy * Patients must not have an active, uncontrolled infection * Female patients MUST NOT be pregnant or breastfeeding; the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED; for women of childbearing potential, a negative serum pregnancy test is required within 10-14 days prior to randomization; for female patients of childbearing potential a negative serum pregnancy test must be repeated within 24 hours prior to initiation of treatment, weekly for the first 4 weeks of treatment and then every 4 weeks if the patient's periods are regular or every 2 weeks if they are not; women of childbearing potential must be willing to refrain from sexual intercourse or must be willing to employ a dual method of contraception, one of which is highly effective \[intrauterine device (IUD), birth control pills, tubal ligation or partner's vasectomy\] and another additional method (condom, diaphragm or cervical cap) starting 4 weeks prior to and while taking lenalidomide and thalidomide and for four weeks after discontinuing this therapy; the male partner of a female using a single form of birth control should use a condom regardless of his vasectomy status * Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking lenalidomide and thalidomide and for 4 weeks after stopping treatment * Patients must not have had a second active malignancy requiring treatment within the last 2 years, with the exceptions of basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix

Locations (392)

Providence Hospital

Mobile, Alabama, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

San Diego VA Medical Center

San Diego, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Atlanta Regional CCOP

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Emory Decatur Hospital

Decatur, Georgia, United States

Dublin Hematology Oncology Care PC

Dublin, Georgia, United States

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Northside Hospital - Gwinnett

Lawrenceville, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Southern Regional Medical Center

Riverdale, Georgia, United States

Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, United States

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Mount Sinai Hospital Medical Center

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Swedish Covenant Hospital

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Saint Francis Hospital

Evanston, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Illinois CancerCare-Cottage

Galesburg, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Illinois CancerCare-Havana

Havana, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Duly Health and Care Joliet

Joliet, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Kewanee Hospital

Kewanee, Illinois, United States

AMITA Health Adventist Medical Center

La Grange, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Spector, David MD (UIA Investigator)

Moline, Illinois, United States

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Trinity Medical Center

Moline, Illinois, United States

Holy Family Medical Center

Monmouth, Illinois, United States

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Carle BroMenn Medical Center

Normal, Illinois, United States

Carle Cancer Institute Normal

Normal, Illinois, United States

Illinois CancerCare-Community Cancer Center

Normal, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

Pekin Hospital

Pekin, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois Valley Hospital

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

Swedish American Hospital

Rockford, Illinois, United States

Illinois CancerCare-Spring Valley

Spring Valley, Illinois, United States

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, United States

IU Health Arnett Cancer Care

Lafayette, Indiana, United States

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

The Community Hospital

Munster, Indiana, United States

Reid Health

Richmond, Indiana, United States

McFarland Clinic - Ames

Ames, Iowa, United States

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

MercyOne Genesis Davenport Medical Center

Davenport, Iowa, United States

MercyOne Genesis Davenport Cancer Center

Davenport, Iowa, United States

Mercy Capitol