NCT00602641

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P50-P75 for phase_3 multiple-myeloma

Timeline
10mo left

Started Feb 2008

Longer than P75 for phase_3 multiple-myeloma

Geographic Reach
2 countries

392 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Feb 2008Feb 2027

First Submitted

Initial submission to the registry

January 18, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

February 29, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 29, 2015

Completed
11.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Expected
Last Updated

April 29, 2026

Status Verified

February 1, 2026

Enrollment Period

5.9 years

First QC Date

January 18, 2008

Results QC Date

May 5, 2015

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    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 Outcomes (3)

  • Overall Survival

    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

    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

    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.

Study Arms (2)

Arm I (thalidomide)

ACTIVE COMPARATOR

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: Laboratory Biomarker AnalysisDrug: MelphalanDrug: PrednisoneOther: Quality-of-Life AssessmentDrug: Thalidomide

Arm II (lenalidomide)

EXPERIMENTAL

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.

Other: Laboratory Biomarker AnalysisDrug: LenalidomideDrug: MelphalanDrug: Prednisone

Interventions

Optional correlative studies

Arm I (thalidomide)Arm II (lenalidomide)

Given PO

Also known as: CC 5013, CC-5013, CC5013, CDC 501, Revlimid
Arm II (lenalidomide)

Given PO

Also known as: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalan for Injection-Hepatic Delivery System, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813
Arm I (thalidomide)Arm II (lenalidomide)

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone
Arm I (thalidomide)Arm II (lenalidomide)

Ancillary studies

Also known as: Quality of Life Assessment
Arm I (thalidomide)

Given PO

Also known as: (+)-Thalidomide, (-)-Thalidomide, .alpha.-Phthalimidoglutarimide, 2, 6-Dioxo-3-phthalimidopiperidine, Alpha-Phthalimidoglutarimide, Contergan, Distaval, Kevadon, 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, Sedoval K17, Softenon, Synovir, Talimol, Thalomid
Arm I (thalidomide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (392)

Providence Hospital

Mobile, Alabama, 36608, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Sparks Regional Medical Center

Fort Smith, Arkansas, 72901, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

Kaiser Permanente-San Diego Mission

San Diego, California, 92108, United States

Location

San Diego VA Medical Center

San Diego, California, 92161, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Boulder Community Foothills Hospital

Boulder, Colorado, 80303, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

AdventHealth Porter

Denver, Colorado, 80210, United States

Location

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

Location

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Western States Cancer Research NCORP

Denver, Colorado, 80222, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States

Location

Banner North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, 80539, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, 80401, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Atlanta Regional CCOP

Atlanta, Georgia, 30342, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

John B Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

Location

Dublin Hematology Oncology Care PC

Dublin, Georgia, 31021, United States

Location

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

Location

Northside Hospital - Gwinnett

Lawrenceville, Georgia, 30046, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Location

Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, 30165, United States

Location

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Mount Sinai Hospital Medical Center

Chicago, Illinois, 60608, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Heartland Cancer Research NCORP

Decatur, Illinois, 62526, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Saint Francis Hospital

Evanston, Illinois, 60202, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Cottage

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Havana

Havana, Illinois, 62644, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, 60521, United States

Location

Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States

Location

Duly Health and Care Joliet

Joliet, Illinois, 60435, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

AMITA Health Adventist Medical Center

La Grange, Illinois, 60525, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, 61265, United States

Location

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, 61265, United States

Location

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, 61265, United States

Location

Spector, David MD (UIA Investigator)

Moline, Illinois, 61265, United States

Location

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, 61265, United States

Location

Trinity Medical Center

Moline, Illinois, 61265, United States

Location

Holy Family Medical Center

Monmouth, Illinois, 61462, United States

Location

Illinois CancerCare-Monmouth

Monmouth, Illinois, 61462, United States

Location

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

Location

Carle BroMenn Medical Center

Normal, Illinois, 61761, United States

Location

Carle Cancer Institute Normal

Normal, Illinois, 61761, United States

Location

Illinois CancerCare-Community Cancer Center

Normal, Illinois, 61761, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554, United States

Location

Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Illinois Valley Hospital

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

Swedish American Hospital

Rockford, Illinois, 61104, United States

Location

Illinois CancerCare-Spring Valley

Spring Valley, Illinois, 61362, United States

Location

Saint Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, 46107, United States

Location

IU Health Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, 46360, United States

Location

The Community Hospital

Munster, Indiana, 46321, United States

Location

Reid Health

Richmond, Indiana, 47374, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, 52722, United States

Location

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, 52722, United States

Location

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

Clive, Iowa, 50325, United States

Location

MercyOne Genesis Davenport Medical Center

Davenport, Iowa, 52803, United States

Location

MercyOne Genesis Davenport Cancer Center

Davenport, Iowa, 52804, United States

Location

Mercy Capitol

Des Moines, Iowa, 50307, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, 50309, United States

Location

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Iowa City VA Healthcare System

Iowa City, Iowa, 52246, United States

Location

Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Ottumwa Regional Health Center

Ottumwa, Iowa, 52501, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center-Sioux City

Sioux City, Iowa, 51102, United States

Location

Saint Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cedar Valley Medical Specialists

Waterloo, Iowa, 50701, United States

Location

MercyOne Waterloo Cancer Center

Waterloo, Iowa, 50702, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, 66606, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Doctors Carrol, Sheth, Raghavan

Louisville, Kentucky, 40215, United States

Location

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, 42303, United States

Location

Ochsner Health Center-Summa

Baton Rouge, Louisiana, 70809, United States

Location

Ochsner Health Center-Covington

Covington, Louisiana, 70433, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Mercy Hospital

Portland, Maine, 04101, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930, United States

Location

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States

Location

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Beacon Kalamazoo

Kalamazoo, Michigan, 49048, United States

Location

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

Lake Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

Location

Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States

Location

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

Location

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

Miller-Dwan Hospital

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Lake Region Healthcare Corporation-Cancer Care

Fergus Falls, Minnesota, 56537, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Litchfield, Minnesota, 55355, United States

Location

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Saint Joseph's Hospital - Healtheast

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Fairview Cancer Center - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

Location

Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

Cox Cancer Center Branson

Branson, Missouri, 65616, United States

Location

Southeast Missouri Hospital

Cape Girardeau, Missouri, 63701, United States

Location

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Saint Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65804, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Care PC

St Louis, Missouri, 63141, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, 63141, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

Saint Vincent Healthcare

Billings, Montana, 59101, United States

Location

Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States

Location

Saint Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Northern Montana Hospital

Havre, Montana, 59501, United States

Location

Saint Peter's Community Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Logan Health Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States

Location

Community Medical Center

Missoula, Montana, 59804, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

CHI Health Good Samaritan

Kearney, Nebraska, 68847, United States

Location

Nebraska Cancer Research Center

Lincoln, Nebraska, 68510, United States

Location

Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Alegent Health Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, 89120, United States

Location

Nevada Cancer Institute-Summerlin Campus

Las Vegas, Nevada, 89135, United States

Location

Veterans Adminstration New Jersey Health Care System

East Orange, New Jersey, 07018-1095, United States

Location

Virtua Memorial

Mount Holly, New Jersey, 08060, United States

Location

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

Virtua Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Kings County Hospital

Brooklyn, New York, 11203, United States

Location

State University of New York Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, 13057, United States

Location

Veterans Affairs New York Harbor Healthcare System-Manhattan Campus

New York, New York, 10010, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Syracuse Veterans Administration Medical Center

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center-Wakefield Campus

The Bronx, New York, 10466, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

ECU Health Oncology Kinston

Kinston, North Carolina, 28501, United States

Location

UNC Health Cancer Care Raleigh

Raleigh, North Carolina, 27607, United States

Location

Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

Saint Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

Location

Summa Health System - Akron Campus

Akron, Ohio, 44304, United States

Location

Summa Health System - Barberton Campus

Barberton, Ohio, 44203, United States

Location

Mary Rutan Hospital

Bellefontaine, Ohio, 43311, United States

Location

Cleveland Clinic Mercy Hospital

Canton, Ohio, 44708, United States

Location

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Columbus NCI Community Oncology Research Program

Columbus, Ohio, 43215, United States

Location

Grant Medical Center

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health Center West

Columbus, Ohio, 43222, United States

Location

Doctors Hospital

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

Location

Dayton Veterans Affairs Medical Center

Dayton, Ohio, 45428, United States

Location

Dayton NCI Community Oncology Research Program

Dayton, Ohio, 45459, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Blanchard Valley Hospital

Findlay, Ohio, 45840, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Saint Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Springfield Regional Medical Center

Springfield, Ohio, 45504, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

Saint Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center

Wilmington, Ohio, 45177, United States

Location

Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701, United States

Location

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

Location

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

Location

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Adventist Medical Center

Portland, Oregon, 97216, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Compass Oncology Rose Quarter

Portland, Oregon, 97227, United States

Location

Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

WellSpan Medical Oncology and Hematology

Hanover, Pennsylvania, 17331, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Central PA Hematology-Medical Oncology Associates PC

Lemoyne, Pennsylvania, 17043, United States

Location

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

Location

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

Reading Hospital McGlinn Cancer Institute at Phoenixville

Phoenixville, Pennsylvania, 19460, United States

Location

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

UPMC Susquehanna

Williamsport, Pennsylvania, 17701, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Main Line Health NCORP

Wynnewood, Pennsylvania, 19096, United States

Location

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403, United States

Location

WellSpan Health-York Hospital

York, Pennsylvania, 17403, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center

Sioux Falls, South Dakota, 57105, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57117-5045, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Cookeville Regional Medical Center

Cookeville, Tennessee, 38501, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

The Jackson Clinic PA

Jackson, Tennessee, 38301, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Sovah Health Martinsville

Martinsville, Virginia, 24112, United States

Location

MultiCare Auburn Medical Center

Auburn, Washington, 98001, United States

Location

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531, United States

Location

Saint Francis Hospital

Federal Way, Washington, 98003, United States

Location

Saint Clare Hospital

Lakewood, Washington, 98499, United States

Location

Providence - Saint Peter Hospital

Olympia, Washington, 98506-5166, United States

Location

MultiCare Good Samaritan Hospital

Puyallup, Washington, 98372, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States

Location

MultiCare Allenmore Hospital

Tacoma, Washington, 98405, United States

Location

MultiCare Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Northwest NCI Community Oncology Research Program

Tacoma, Washington, 98405, United States

Location

Saint Joseph Medical Center

Tacoma, Washington, 98405, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

Location

West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States

Location

Camden Clark Medical Center

Parkersburg, West Virginia, 26101, United States

Location

Princeton Community Hospital

Princeton, West Virginia, 24740, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

Location

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, 54701, United States

Location

Saint Agnes Hospital/Agnesian Cancer Center

Fond du Lac, Wisconsin, 54935, United States

Location

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, 53038, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

SSM Health Dean Medical Group - South Madison Campus

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Medical Center

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

Location

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

Location

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

Location

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

Location

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Rocky Mountain Oncology

Casper, Wyoming, 82609, United States

Location

Welch Cancer Center

Sheridan, Wyoming, 82801, United States

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

  • Stewart AK, Jacobus S, Fonseca R, Weiss M, Callander NS, Chanan-Khan AA, Rajkumar SV. Melphalan, prednisone, and thalidomide vs melphalan, prednisone, and lenalidomide (ECOG E1A06) in untreated multiple myeloma. Blood. 2015 Sep 10;126(11):1294-301. doi: 10.1182/blood-2014-12-613927. Epub 2015 Jul 8.

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

LenalidomideMelphalanPrednisonedeltacorteneprednylideneThalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Study Statistician
Organization
ECOG Statistical Office

Study Officials

  • Alexander K Stewart

    ECOG-ACRIN Cancer Research Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 28, 2008

Study Start

February 29, 2008

Primary Completion

January 18, 2014

Study Completion (Estimated)

February 20, 2027

Last Updated

April 29, 2026

Results First Posted

June 29, 2015

Record last verified: 2026-02

Locations