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

August 27, 2026 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare progression-free survival between patients receiving melphalan, prednisone, and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple myeloma patients who are not candidates for high-dose therapy.

SECONDARY OBJECTIVES:

I. To compare overall survival between the arms. II. To compare response rates and depth of response. III. To compare the incidence of toxicities. IV. To validate the translocation classification (TC) of myeloma as a prognostic tool using gene expression profiling at diagnosis.

TERTIARY OBJECTIVES:

I. To compare quality-of-life (QOL) change between arms based on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Trial Outcome Index (TOI) from registration (prior to initiation of treatment) to the end of cycle 24 (maintenance therapy).

II. To examine the impact of differential treatment response (PFS), if observed, on QOL based on the FACT-Ntx TOI up to cycle 38 (maintenance therapy).

III. To obtain prospective data on myeloma specific QOL attributes.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I:

INDUCTION THERAPY: Patients receive melphalan orally (PO) and prednisone PO once daily (QD) on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression.

ARM II:

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression.

After completion of study treatment, patients are followed up periodically for 10 years.

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Providence Hospital
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Marysville, California, United States, 95901
        • Fremont - Rideout Cancer Center
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center - Hillcrest
      • San Diego, California, United States, 92161
        • San Diego VA Medical Center
      • San Diego, California, United States, 92108
        • Kaiser Permanente-Rio San Diego
      • Truckee, California, United States, 96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80303
        • Boulder Community Foothills Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80222
        • Western States Cancer Research NCORP
      • Denver, Colorado, United States, 80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Denver, Colorado, United States, 80210
        • AdventHealth Porter
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Grand Junction, Colorado, United States, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • Banner North Colorado Medical Center
      • Lakewood, Colorado, United States, 80228
        • CommonSpirit Saint Anthony Hospital Cancer Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80401
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Putney Memorial Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30342
        • Atlanta Regional CCOP
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
      • Austell, Georgia, United States, 30106
        • Wellstar Cobb Hospital
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Emory Decatur Hospital
      • Dublin, Georgia, United States, 31021
        • Dublin Hematology Oncology Care PC
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Lawrenceville, Georgia, United States, 30046
        • Northside Hospital - Gwinnett
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Medical Oncology and Clinical Research
    • Illinois
      • Alton, Illinois, United States, 62002
        • OSF Saint Anthony's Health Center
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, United States, 61701
        • OSF Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Canton, Illinois, United States, 61520
        • Graham Hospital Association
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60608
        • Mount Sinai Hospital Medical Center
      • Chicago, Illinois, United States, 60625
        • Swedish Covenant Hospital
      • Decatur, Illinois, United States, 62526
        • Heartland Cancer Research NCORP
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Evanston, Illinois, United States, 60202
        • Saint Francis Hospital
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Cottage
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Havana, Illinois, United States, 62644
        • Illinois CancerCare-Havana
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates Incorporated
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex - Hospital
      • Joliet, Illinois, United States, 60435
        • Duly Health and Care Joliet
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Kewanee, Illinois, United States, 61443
        • Kewanee Hospital
      • La Grange, Illinois, United States, 60525
        • AMITA Health Adventist Medical Center
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Macomb, Illinois, United States, 61455
        • McDonough District Hospital
      • Moline, Illinois, United States, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Porubcin, Michael MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Spector, David MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Trinity Medical Center
      • Moline, Illinois, United States, 61265
        • Sharis, Christine M MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Stoffel, Thomas J MD (UIA Investigator)
      • Monmouth, Illinois, United States, 61462
        • Illinois CancerCare-Monmouth
      • Monmouth, Illinois, United States, 61462
        • Holy Family Medical Center
      • Mount Vernon, Illinois, United States, 62864
        • SSM Health Good Samaritan
      • Normal, Illinois, United States, 61761
        • Carle Cancer Institute Normal
      • Normal, Illinois, United States, 61761
        • Illinois CancerCare-Community Cancer Center
      • Normal, Illinois, United States, 61761
        • Carle BroMenn Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, United States, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, United States, 61554
        • Pekin Hospital
      • Pekin, Illinois, United States, 61554
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Peru, Illinois, United States, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Rockford, Illinois, United States, 61104
        • Swedish American Hospital
      • Spring Valley, Illinois, United States, 61362
        • Saint Margaret's Hospital
      • Spring Valley, Illinois, United States, 61362
        • Illinois CancerCare-Spring Valley
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Franciscan Saint Francis Health-Beech Grove
      • Lafayette, Indiana, United States, 47904
        • IU Health Arnett Cancer Care
      • Michigan City, Indiana, United States, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Richmond, Indiana, United States, 47374
        • Reid Health
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Bettendorf, Iowa, United States, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Bettendorf, Iowa, United States, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Clive, Iowa, United States, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Davenport, Iowa, United States, 52804
        • MercyOne Genesis Davenport Cancer Center
      • Davenport, Iowa, United States, 52803
        • MercyOne Genesis Davenport Medical Center
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, United States, 50307
        • Mercy Capitol
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, United States, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Iowa City, Iowa, United States, 52246
        • Iowa City VA Healthcare System
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
      • Ottumwa, Iowa, United States, 52501
        • Ottumwa Regional Health Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51102
        • Mercy Medical Center-Sioux City
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
      • Waterloo, Iowa, United States, 50701
        • Cedar Valley Medical Specialists
      • Waterloo, Iowa, United States, 50702
        • MercyOne Waterloo Cancer Center
    • Kansas
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Cancer Center / Stormont Vail Health
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Doctors Carrol, Sheth, Raghavan
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Health Mitchell Memorial Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Health Center-Summa
      • Covington, Louisiana, United States, 70433
        • Ochsner Health Center-Covington
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
    • Maine
      • Portland, Maine, United States, 04101
        • Mercy Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
      • Gloucester, Massachusetts, United States, 01930
        • Addison Gilbert Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium NCORP
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Dearborn, Michigan, United States, 48124
        • Corewell Health Dearborn Hospital
      • Detroit, Michigan, United States, 48236
        • Henry Ford Health Saint John Hospital
      • Flint, Michigan, United States, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Beacon Kalamazoo
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Pontiac, Michigan, United States, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Port Huron, Michigan, United States, 48060
        • Lake Huron Medical Center
      • Saginaw, Michigan, United States, 48601
        • MyMichigan Medical Center Saginaw
      • Warren, Michigan, United States, 48093
        • Henry Ford Health Warren Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, United States, 56537
        • Lake Region Healthcare Corporation-Cancer Care
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, United States, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Saint Paul, Minnesota, United States, 55102
        • Saint Joseph's Hospital - Healtheast
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Woodbury, Minnesota, United States, 55125
        • Fairview Cancer Center - Woodbury
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Singing River Hospital
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, United States, 65616
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, United States, 63701
        • Southeast Missouri Hospital
      • Cape Girardeau, Missouri, United States, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Chesterfield, Missouri, United States, 63017
        • Saint Luke's Hospital
      • Jefferson City, Missouri, United States, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Springfield, Missouri, United States, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, United States, 63141
        • Comprehensive Cancer Care PC
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63141
        • Saint Louis-Cape Girardeau CCOP
      • St Louis, Missouri, United States, 63141
        • Center for Cancer Care and Research
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59102
        • Montana Cancer Consortium NCORP
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nebraska
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68510
        • Nebraska Cancer Research Center
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68106
        • Missouri Valley Cancer Consortium
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute-Summerlin Campus
      • Las Vegas, Nevada, United States, 89120
        • Nevada Cancer Research Foundation NCORP
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Adminstration New Jersey Health Care System
      • Mount Holly, New Jersey, United States, 08060
        • Virtua Memorial
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Newark, New Jersey, United States, 07101
        • Rutgers New Jersey Medical School
      • Voorhees Township, New Jersey, United States, 08043
        • Virtua Voorhees
    • New York
      • Brooklyn, New York, United States, 11203
        • Kings County Hospital
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • New York, New York, United States, 10010
        • Veterans Affairs New York Harbor Healthcare System-Manhattan Campus
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • Syracuse Veterans Administration Medical Center
      • The Bronx, New York, United States, 10466
        • Montefiore Medical Center-Wakefield Campus
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
      • Kinston, North Carolina, United States, 28501
        • ECU Health Oncology Kinston
      • Raleigh, North Carolina, United States, 27607
        • UNC Health Cancer Care Raleigh
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, United States, 58501
        • Saint Alexius Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System - Akron Campus
      • Barberton, Ohio, United States, 44203
        • Summa Health System - Barberton Campus
      • Bellefontaine, Ohio, United States, 43311
        • Mary Rutan Hospital
      • Canton, Ohio, United States, 44708
        • Cleveland Clinic Mercy Hospital
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, United States, 43215
        • Columbus NCI Community Oncology Research Program
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45405
        • Grandview Hospital
      • Dayton, Ohio, United States, 45459
        • Dayton NCI Community Oncology Research Program
      • Dayton, Ohio, United States, 45428
        • Dayton Veterans Affairs Medical Center
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Findlay, Ohio, United States, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Wayne Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45801
        • Saint Rita's Medical Center
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Springfield, Ohio, United States, 45504
        • Springfield Regional Medical Center
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Wilmington, Ohio, United States, 45177
        • Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
      • Xenia, Ohio, United States, 45385
        • Greene Memorial Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cancer Centers of Southwest Oklahoma Research
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Clackamas Radiation Oncology Center
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, United States, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital and Health Center
      • Portland, Oregon, United States, 97216
        • Adventist Medical Center
      • Portland, Oregon, United States, 97227
        • Compass Oncology Rose Quarter
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, United States, 17331
        • WellSpan Medical Oncology and Hematology
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lemoyne, Pennsylvania, United States, 17043
        • Central PA Hematology-Medical Oncology Associates PC
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center Philadelphia
      • Phoenixville, Pennsylvania, United States, 19460
        • Reading Hospital McGlinn Cancer Institute at Phoenixville
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
      • Williamsport, Pennsylvania, United States, 17701
        • UPMC Susquehanna
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health NCORP
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Cancer Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57117-5045
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Cookeville, Tennessee, United States, 38501
        • Cookeville Regional Medical Center
      • Jackson, Tennessee, United States, 38301
        • Jackson-Madison County General Hospital
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic PA
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, United States, 24112
        • Sovah Health Martinsville
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Olympia, Washington, United States, 98506-5166
        • Providence - Saint Peter Hospital
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, United States, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • Northwest NCI Community Oncology Research Program
      • Tacoma, Washington, United States, 98405
        • Saint Joseph Medical Center
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Charleston Division
      • Parkersburg, West Virginia, United States, 26101
        • Camden Clark Medical Center
      • Princeton, West Virginia, United States, 24740
        • Princeton Community Hospital
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • HSHS Sacred Heart Hospital
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Fond du Lac, Wisconsin, United States, 54935
        • Saint Agnes Hospital/Agnesian Cancer Center
      • Johnson Creek, Wisconsin, United States, 53038
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, United States, 53715
        • SSM Health Dean Medical Group - South Madison Campus
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Medical Center - Minocqua
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Rhinelander, Wisconsin, United States, 54501
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54481
        • Aspirus Cancer Care - Stevens Point
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Cancer Care-Wausau
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus Cancer Care - Wisconsin Rapids
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (thalidomide)

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Prednisone
Given PO
Other Names:
  • Deltasone
  • Orasone
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Thalidomide
Given PO
Other Names:
  • Kevadon
  • Synovir
  • Thalomid
  • (+)-Thalidomide
  • (-)-Thalidomide
  • .alpha.-Phthalimidoglutarimide
  • 2, 6-Dioxo-3-phthalimidopiperidine
  • Alpha-Phthalimidoglutarimide
  • Contergan
  • Distaval
  • N-(2,6-Dioxo-3-piperidyl)phthalimide
  • N-Phthaloylglutamimide
  • N-Phthalylglutamic Acid Imide
  • Neurosedyn
  • Pantosediv
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-
  • Sedalis
  • Sedoval K-17
  • Softenon
  • Talimol
  • Sedoval K17
Drug: Melphalan
Given PO
Other Names:
  • CB-3025
  • L-PAM
  • L-Sarcolysin
  • Alanine Nitrogen Mustard
  • L-Phenylalanine Mustard
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine Nitrogen Mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813
  • Melphalan for Injection-Hepatic Delivery System
Experimental: Arm II (lenalidomide)

INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression.
Drug: Prednisone
Given PO
Other Names:
  • Deltasone
  • Orasone
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
  • CC 5013
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Melphalan
Given PO
Other Names:
  • CB-3025
  • L-PAM
  • L-Sarcolysin
  • Alanine Nitrogen Mustard
  • L-Phenylalanine Mustard
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine Nitrogen Mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813
  • Melphalan for Injection-Hepatic Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
PFS is defined as the time from randomization to the earlier of progression or death of any cause.
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
Overall survival was defined as time from randomization to death from any cause.
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.
Very Good Partial Response (VGPR) Rate
Time Frame: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.
Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria.
Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.
Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12
Time Frame: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.
A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome).
Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alexander K Stewart, ECOG-ACRIN Cancer Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2008

Primary Completion (Actual)

January 18, 2014

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimated)

January 28, 2008

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-00522 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH Grant/Contract)
  • U10CA021115 (U.S. NIH Grant/Contract)
  • ECOG-E1A06
  • CDR0000583984
  • E1A06 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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