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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00602641
First received: January 18, 2008
Last updated: July 30, 2014
Last verified: May 2014
  Purpose

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 or by stopping them from dividing. 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.


Condition Intervention Phase
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Drug: melphalan
Drug: prednisone
Drug: thalidomide
Drug: lenalidomide
Other: quality-of-life assessment
Other: laboratory biomarker analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid™) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: From randomization to the earlier of progression or death of any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
    Tested using one-sided 0.95 confidence limits.

  • Mean change of the FACT-Ntx TOI score and the multiple myeloma specific subscale instruments (MMS) [ Time Frame: Baseline to up to week 96 ] [ Designated as safety issue: No ]
    Differences between treatment arms are detected by 2-sample t-test, with 80% power, at a two-sided 0.05 significance level. Analyzed according to the methods described in Schluchter and in Schluchter, Greene and Beck.


Secondary Outcome Measures:
  • Response rates (complete response + very good partial response + partial response) based on International Uniform Response Criteria for Multiple Myeloma [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Compared between arms using the Fisher's exact test.

  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Estimated using the method of Kaplan and Meier. Compared between the two arms using two-sided stratified log-rank test.

  • Toxicity (rates of grade 3 or higher serious adverse events on the two arms), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Compared using the Fisher's exact test.

  • Change in the FACT-Ntx TOI mean scores between patients that experience disease progression (PD) [ Time Frame: Baseline up to week 152 ] [ Designated as safety issue: No ]
    Evaluated using mixed effects model.

  • Change in the FACT-Ntx TOI mean scores between patients that do not experience PD [ Time Frame: Baseline up to week 152 ] [ Designated as safety issue: No ]
    Evaluated using mixed effects model. Analyzed according to the methods described in Schluchter and in Schluchter, Greene and Beck.


Other Outcome Measures:
  • Reliability between the MMS subscales [ Time Frame: Up to week 96 ] [ Designated as safety issue: No ]
    Provided with descriptive statistics and calculated using Chronbach's alpha.

  • Reliability between the Ntx subscales [ Time Frame: Up to week 96 ] [ Designated as safety issue: No ]
    Provided with descriptive statistics and calculated using Chronbach's alpha.


Estimated Enrollment: 304
Study Start Date: February 2008
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: melphalan
Given PO
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: thalidomide
Given PO
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: laboratory biomarker analysis
Optional correlative studies
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: melphalan
Given PO
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: lenalidomide
Given PO
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Other: laboratory biomarker analysis
Optional correlative studies

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 (TC) classification 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 baseline to the end of course 24 (maintenance therapy).

II. To examine the impact of differential treatment responses, 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 will be followed periodically for 10 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602641

  Hide Study Locations
Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
University of California San Diego
San Diego, California, United States, 92103
Kaiser Permanente
San Diego, California, United States, 92120
Veterans Administration-San Diego Medical Center
San Diego, California, United States, 92161
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Swedish Medical Center
Englewood, Colorado, United States, 80113
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States, 33140
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Northside Hospital
Atlanta, Georgia, United States, 30342
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Atlanta Regional CCOP
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Georgia Regents University
Augusta, Georgia, United States, 30912
Well Star Cobb Hospital
Austell, Georgia, United States, 30106
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Dublin Hematology Oncology Care PC
Dublin, Georgia, United States, 31021
Piedmont Fayette Hospital
Fayetteville, Georgia, United States, 30214
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States, 30165
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
University of Chicago
Chicago, Illinois, United States, 60637
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
University of Illinois
Chicago, Illinois, United States, 60612
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States, 60608
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Saint Francis Hospital
Evanston, Illinois, United States, 60202
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Cottage
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States, 60521
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Adventist La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Spector, David MD (UIA Investigator)
Moline, Illinois, United States, 61265
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, United States, 61265
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Trinity Medical Center
Moline, Illinois, United States, 61265
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Proctor Hospital
Peoria, Illinois, United States, 61614
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Swedish American Hospital
Rockford, Illinois, United States, 61104
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
IU Health Arnett
Lafayette, Indiana, United States, 47904
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States, 52722
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Genesis Medical Center - West Campus
Davenport, Iowa, United States, 52804
Genesis Medical Center - East Campus
Davenport, Iowa, United States, 52803
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Mercy Capitol
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Covenant Medical Center
Waterloo, Iowa, United States, 50702
United States, Kansas
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Doctors Carrol, Sheth, Raghavan
Louisville, Kentucky, United States, 40215
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States, 70809
Ochsner Health Center-Covington
Covington, Louisiana, United States, 70433
Ochsner Clinic CCOP
New Orleans, Louisiana, United States, 70121
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maine
Mercy Hospital
Portland, Maine, United States, 04101
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States, 56537
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States, 65613
CoxHealth Cancer Center
Branson, Missouri, United States, 65616
Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Comprehensive Cancer Care PC
Saint Louis, Missouri, United States, 63141
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
Nebraska Cancer Research Center
Lincoln, Nebraska, United States, 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Kings County Hospital
Brooklyn, New York, United States, 11203
University Hospital of Brooklyn
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York PC-East Syracuse
East Syracuse, New York, United States, 13057
Veterans Affairs New York Harbor Healthcare System-Manhattan Campus
New York, New York, United States, 10010
University of Rochester
Rochester, New York, United States, 14642
Syracuse Veterans Administration Medical Center
Syracuse, New York, United States, 13210
United States, North Carolina
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States, 27534
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Rex Cancer Center
Raleigh, North Carolina, United States, 27607
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Mercy Medical Center
Canton, Ohio, United States, 44708
Aultman Health Foundation
Canton, Ohio, United States, 44710
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Columbus CCOP
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
Doctors Hospital
Columbus, Ohio, United States, 43228
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Veteran Affairs Medical Center
Dayton, Ohio, United States, 45428
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Dayton CCOP
Dayton, Ohio, United States, 45420
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Adventist Medical Center
Portland, Oregon, United States, 97216
Compass Oncology Rose Quarter
Portland, Oregon, United States, 97227
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Central PA Hematology-Medical Oncology Associates PC
Lemoyne, Pennsylvania, United States, 17043
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Mainline Health CCOP
Wynnewood, Pennsylvania, United States, 19096
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health-York Cancer Center
York, Pennsylvania, United States, 17403
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Cookeville Regional Medical Center
Cookeville, Tennessee, United States, 38501
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
The Jackson Clinic PA
Jackson, Tennessee, United States, 38301
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States, 24115
United States, Washington
Auburn Regional Medical Center
Auburn, Washington, United States, 98001
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Saint Clare Hospital
Lakewood, Washington, United States, 98499
Providence - Saint Peter Hospital
Olympia, Washington, United States, 98506-5166
Good Samaritan Community Hospital
Puyallup, Washington, United States, 98372
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Multicare Health System
Tacoma, Washington, United States, 98415
Northwest CCOP
Tacoma, Washington, United States, 98405
Saint Joseph Medical Center
Tacoma, Washington, United States, 98405
Allenmore Hospital
Tacoma, Washington, United States, 98405
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26101
Princeton Community Hospital
Princeton, West Virginia, United States, 24740
United States, Wisconsin
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Agnesian Cancer Center
Fond Du Lac, Wisconsin, United States, 54935
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Israel
Rambam Medical Center
Haifa, Israel, 31096
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Investigators
Principal Investigator: Alexander Stewart ECOG-ACRIN Cancer Research Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00602641     History of Changes
Other Study ID Numbers: NCI-2009-00522, NCI-2009-00522, CDR0000583984, ECOG-E1A06, E1A06, E1A06, U10CA180820, U10CA021115
Study First Received: January 18, 2008
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Lenalidomide
Prednisone
Thalidomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 01, 2014