Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Biomarker/Laboratory analysis, Natural history/Epidemiology, Treatment	Active	18 and over	NCI	ECOG-E1A06 E1A06, NCT00602641

Special Category: CTSU trial

Objectives

Primary

1. 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

1. To compare overall survival between both arms.
2. To compare response rates and depth of response in these patients.
3. To compare the incidence of toxicities in these patients.
4. To validate the TC classification of myeloma as a prognostic tool using gene expression profiling at diagnosis.

Tertiary

1. To compare quality-of-life (QOL) change between arms based on the FACT-Ntx TOI from baseline to the end of course 24 (maintenance therapy).
2. To examine the impact of differential treatment responses on QOL based on the FACT-Ntx TOI up to course 38.
3. To obtain prospective data on myeloma specific QOL attributes.

Entry Criteria

Disease Characteristics:

• Newly diagnosed multiple myeloma (MM), meeting the following criteria:
  • Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
  • Symptomatic disease with evidence of end-organ damage at initial diagnosis that prompted the initiation of therapy, including ≥ 1 of the following:
    • Anemia
    • Hypercalcemia
    • Bone disease (lytic bone lesions or pathologic fracture)
    • Renal dysfunction
• No smoldering MM, defined by all of the following:
  • Serum monoclonal protein ≥ 3 g/dL
  • Bone marrow plasma cells ≥ 10% or greater
  • Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction
• No monoclonal gammopathy of undetermined significance, defined by all of the following:
  • Serum monoclonal protein < 3 g/dL
  • Bone marrow plasma cells ≤ 10%
  • Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction
• Previously untreated for MM
• Patients 18 to 64 years old must not be a candidate for autologous stem cell transplantation or have declined transplantation or other alternative treatment

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior treatment for myeloma except for either of the following:
  • Prednisone or dexamethasone treatment for myeloma for a duration of less than 4 weeks
  • Prednisone or dexamethasone in combination with thalidomide or lenalidomide for a duration of less than 2 weeks total
• Concurrent bisphosphonates or growth factors (i.e., erythropoietin) for MM allowed
• Concurrent localized radiation therapy is allowed for pain control at the physician’s discretion

Patient Characteristics:

• ECOG performance status 0-2
• Hemoglobin > 7 g/dL
• Platelet count > 75,000/mm³
• ANC > 1,000/mm³
• Creatinine < 2.5 mg/dL AND creatinine clearance (measured or calculated) ≥ 60 mL/min
• Direct bilirubin ≤ 1.5 mg/dL
• ALT and AST ≤ 2.5 times upper limit of normal
• No uncontrolled intercurrent illness that would limit compliance with the study including, but not limited to, any of the following:
  • Uncontrolled hypertension
  • Symptomatic congestive heart failure
  • Unstable angina
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled psychiatric illness or social situation
  • Prior history of Stevens Johnson syndrome
• No peripheral neuropathy ≥ grade 2
• No active uncontrolled infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-barrier contraception 4 weeks prior to, during, and 4 weeks after completion of study treatment
• Must be able to take prophylactic aspirin 325mg/day or low-molecular weight heparin or coumadin
• No second active malignancy requiring treatment within the past 2 years, except for basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix

Expected Enrollment

Outcomes

Progression-free survival
Overall survival

Response rates and depth of response comparison
Toxicity
Quality-of-life (QOL) change comparison of arms measured by FACT-Ntx TOI from baseline to course 24
Differential treatment response on QOL measured by FACT-Ntx TOI from baseline to course 38
TC classification validation of myeloma as a prognostic tool using gene expression profiling

Outline

This is a multicenter study. Patients are stratified according to ISS stage (I-II vs III) and age (< 65 vs ≥ 65). Patients are randomized to 1 of 2 treatment arms.

• Arm I:
  • Induction therapy: Patients receive oral melphalan and oral prednisone once daily on days 1-4, and oral thalidomide once daily 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 oral thalidomide once daily and continue in the absence of disease progression.
• Arm II:
  • Induction therapy: Patients receive oral melphalan and oral prednisone once daily on days 1-4, and oral lenalidomide 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 oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression.

Quality of life is assessed at baseline and periodically during treatment.

Peripheral blood and bone marrow samples are collected at baseline for gene expression profiling analysis.

After completion of study treatment, patients will be followed periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

A. Keith Stewart, MD, Protocol chair		Ph: 480-301-4411
S. Rajkumar, MD, Protocol co-chair		Ph: 507-538-0591 Email: rajkumar.vincent@mayo.edu

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
California
	Marysville
	Tibotec Therapeutics - Division of Ortho Biotech Products, LP
		Joseph Tuscano, MD	Ph:  916-734-3771
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	San Diego
	Kaiser Permanente Medical Office -Vandever Medical Office
		Han Koh	Ph:  619-528-2596
	Truckee
	Tahoe Forest Cancer Center
		Joseph Tuscano, MD	Ph:  916-734-3771
Colorado
	Fort Collins
	Front Range Cancer Specialists
		Robert Marschke, Jr.	Ph:  970-212-7600
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
District of Columbia
	Washington
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Rogerio Lilenbaum, MD	Ph:  305-535-3310
Georgia
	Albany
	Phoebe Cancer Center at Phoebe Putney Memorial Hospital
		Clinical Trials Office - Phoebe Cancer Center	Ph:  229-312-2251
	Altanta
	Winship Cancer Institute of Emory University
		Leonard Heffner, MD	Ph:  404-778-4348
	Atlanta
	CCOP - Atlanta Regional
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Northside Hospital Cancer Center
		Clinical Trials Office - Northside Hospital Cancer Center	Ph:  404-303-3355
	Piedmont Hospital
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Saint Joseph's Hospital of Atlanta
		Clinical Trials Office - Saint Joseph's Hospital of Atlanta	Ph:  404-851-7115
	Augusta
	MBCCOP - Medical College of Georgia Cancer Center
		Anand Jillella, MD	Ph:  706-721-2505
	Austell
	WellStar Cobb Hospital
		Clinical Trials Office - WellStar Cobb Hospital	Ph:  770-793-5980
	Columbus
	John B. Amos Cancer Center
		Clinical Trials Office - John B. Amos Cancer Center	Ph:  706-660-6404
	Decatur
	Charles B. Eberhart Cancer Center at DeKalb Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Lawrenceville
	Gwinnett Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Marietta
	Kennestone Cancer Center at Wellstar Kennestone Hospital
		Clinical Trials Office - Kennestone Cancer Center	Ph:  770-793-5980
	Riverdale
	Southern Regional Medical Center
		Clinical Trials Office - Southern Regional Medical Center	Ph:  770-991-8611
	Rome
	Harbin Clinic Cancer Center - Medical Oncology
		Thomas Seay, MD, PhD	Ph:  404-851-2340
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3605
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Evanston
	Evanston Hospital
		Clinical Trials Office - Evanston Hospital	Ph:  847-570-1381
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3605
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3605
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Hinsdale
	Hinsdale Hematology Oncology Associates
		Elyse Schneiderman, MD	Ph:  630-654-1790
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3605
	Moline
		Costas Constantinou, MD	Ph:  563-359-9876
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas Constantinou, MD	Ph:  563-359-9876
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3605
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3605
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3605
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3605
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3605
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3605
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3605
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3605
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3605
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  937-832-1093
	Munster
	Community Hospital
		Erwin Robin, MD	Ph:  219-836-2860
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  937-832-1093
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Bettendorf
		Costas Constantinou, MD	Ph:  563-359-9876
	Hematology Oncology Associates of the Quad Cities
		Shobha Chitneni, MD, MBBS	Ph:  563-355-7733
	Clive
	Medical Oncology and Hematology Associates - West Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Davenport
	Genesis Medical Center - West Campus
		George Kovach, MD	Ph:  563-421-1960
	Genesis Regional Cancer Center at Genesis Medical Center
		George Kovach, MD	Ph:  563-421-1960
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-282-2921
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Veterans Affairs Medical Center - Iowa City
		Daniel Vaena	Ph:  319-338-0581 800-637-0128
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa	Ph:  641-422-6304
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Robert Behrens	Ph:  641-684-2946
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Waterloo
	Covenant Cancer Treatment Center
		Clinical Trials Office - Covenant Cancer Treatment Center	Ph:  319-272-2070
Kansas
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
	Wichita
	Wesley Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Maine
	Portland
	Mercy Hospital
		Roger Inhorn, MD, PhD	Ph:  207-879-3030
Massachusetts
	Burlington
	Lahey Clinic Medical Center - Burlington
		Clinical Trials Office - Lahey Clinic Medical Center - Burlington	Ph:  781-744-8027
Michigan
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
Minnesota
	Bemidji
	MeritCare Bemidji
		Preston Steen, MD	Ph:  701-234-2397
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Fergus Falls
	Fergus Falls Medical Group, PA
		Preston Steen, MD	Ph:  701-234-2397
	Hutchinson
	Hutchinson Area Health Care
		Patrick Flynn, MD	Ph:  612-863-8585
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Veterans Affairs Medical Center - Minneapolis
		Clinical Trials Office - Veterans Affairs Medical Center - Minneapolis	Ph:  612-467-2800
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Chesterfield
	Saint Luke's Hospital
		Donald Busiek, MD	Ph:  314-205-6737
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-7057
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	Midwest Hematology Oncology Group, Incorporated
		Bethany Sleckman, MD	Ph:  314-251-7057
	Springfield
	CCOP - Cancer Research for the Ozarks
		Robert Carolla	Ph:  417-269-4520
	St. John's Regional Health Center
		Robert Carolla	Ph:  417-820-2000
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
		Benjamin Marchello, MD	Ph:  406-238-6290
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-238-6290
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
Nebraska
	Kearney
	Good Samaritan Cancer Center at Good Samaritan Hospital
		Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital	Ph:  308-865-7963
	Lincoln
	Cancer Resource Center - Lincoln
		Alan Berg, MD	Ph:  402-420-7000
	Omaha
	Alegant Health Cancer Center at Bergan Mercy Medical Center
		Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center	Ph:  402-398-6060
	CCOP - Missouri Valley Cancer Consortium
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	Creighton University Medical Center
		Clinical Trials Office - Creighton University Medical Center	Ph:  402-280-4100
	Immanuel Medical Center
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Ellerton, MD, CM	Ph:  702-384-0013
	University Medical Center of Southern Nevada
		John Ellerton, MD, CM	Ph:  702-384-0013
New Jersey
	East Orange
	Veterans Affairs Medical Center - East Orange
		Basil Kasimis, MD, DSc	Ph:  973-395-7809
	Marlton
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
		Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Ph:  888-847-8823
	New Brunswick
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
		Clinical Trials Office - Cancer Institute of New Jersey	Ph:  732-235-8675
	Voorhees
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Michael Entmacher, MD	Ph:  609-702-1900
New York
	Bronx
	Our Lady of Mercy Medical Center Comprehensive Cancer Center
		Peter Wiernik, MD	Ph:  718-304-7200
	Brooklyn
	Kings County Hospital Center
		Olcay Batuman	Ph:  718-245-3901
	SUNY Downstate Medical Center
		Olcay Batuman	Ph:  718-270-4293
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Richard Fisher, MD	Ph:  585-275-0842
	Syracuse
	Veterans Affairs Medical Center - Syracuse
		Jane Hudson	Ph:  315-425-4400 800-792-4334
North Carolina
	Charlotte
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
	Goldsboro
	Southeastern Medical Oncology Center - Goldsboro
		James Atkins, MD	Ph:  919-580-0000
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Raleigh
	Rex Cancer Center at Rex Hospital
		Clinical Trials Office - Rex Cancer Center	Ph:  919-784-7209
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Mid Dakota Clinic, PC
		Clinical Trials Office - Mid Dakota Clinic, PC	Ph:  701-530-6950
	St. Alexius Medical Center Cancer Center
		Clinical Trials Office - St. Alexius Medical Center Cancer Center	Ph:  701-530-6950
	Fargo
	CCOP - MeritCare Hospital
		Preston Steen, MD	Ph:  701-234-2397
	MeritCare Broadway
		Preston Steen, MD	Ph:  701-234-2397
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Barberton
	Barberton Citizens Hospital
		Jennifer Payne	Ph:  330-745-1611
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Mercy Cancer Center at Mercy Medical Center
		Mitchell Haut, MD	Ph:  330-453-9993
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Grandview Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-832-1093
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Greenville
	Wayne Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mercy Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Wilmington
	Clinton Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Oklahoma
	Lawson
	Cleo Craig Cancer Research Clinic
		Nadim Nimeh, MD	Ph:  580-536-2121ext.113
Oregon
	Milwaukie
	Providence Milwaukie Hospital
		Janet Ruzich	Ph:  503-513-8300
	Portland
	Adventist Medical Center
		Janet Ruzich	Ph:  503-257-2500
	CCOP - Columbia River Oncology Program
		Janet Ruzich	Ph:  503-216-6260
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center	Ph:  503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph:  503-215-6412
Pennsylvania
	Bryn Mawr
	Bryn Mawr Hospital
		Clinical Trials Office - Bryn Mawr Hospital	Ph:  610-645-2680
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Lemoyne
	Central Pennsylvania Hematology and Medical Oncology Associates, PC
		John Conroy, DO, FACP, FACOI	Ph:  717-737-5767
	Paoli
	Cancer Center of Paoli Memorial Hospital
		Clinical Trials Office - Cancer Center of Paoli Memorial Hospital	Ph:  610-648-1637
	Williamsport
	Susquehanna Cancer Center at Divine Providence Hospital
		Warren Robinson, Jr.	Ph:  570-326-8000
	Wynnewood
	CCOP - Main Line Health
		Paul Gilman, MD	Ph:  610-645-2000
	Lankenau Cancer Center at Lankenau Hospital
		Paul Gilman, MD	Ph:  610-645-2000
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Richard Tenglin	Ph:  605-719-2360
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  800-811-8480
Texas
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
Virginia
	Charlottesville
	University of Virginia Cancer Center
		John Densmore, MD	Ph:  434-924-9637
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
	Martinsville
	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
		Arthur Sleeper, MD	Ph:  276-666-7200
Washington
	Auburn
	Auburn Regional Center for Cancer Care
		Lauren Colman, MD	Ph:  253-403-1677
	Centralia
	Providence Centralia Hospital
		Clinical Trials Office - Providence Centralia Hospital	Ph:  360-493-4300
	Federal Way
	St. Francis Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	Olympia
	Providence St. Peter Hospital Regional Cancer Center
		Lauren Colman, MD	Ph:  253-403-1677
	Puyallup
	Good Samaritan Cancer Center
		Lauren Colman, MD	Ph:  253-403-1677
	Seattle
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	Tacoma
	Allenmore Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	CCOP - Northwest
		Lauren Colman, MD	Ph:  253-403-1677
	Franciscan Cancer Center at St. Joseph Medical Center
		Clinical Trials Office - Franciscan Cancer Center	Ph:  253-426-6914
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Clinical Trials Office - MultiCare Regional Cancer Center	Ph:  253-403-3229
	St. Clare Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Janet Ruzich	Ph:  360-514-2174
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Steven Jubelirer, MD	Ph:  304-388-8380
Wisconsin
	Johnson Creek
	UW Cancer Center Johnson Creek
		Natalie Callander, MD	Ph:  608-263-1836
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Oconomowoc
	Regional Cancer Center at Oconomowoc Memorial Hospital
		Clinical Trials Office - Regional Cancer Center at Oconomowoc Memorial Hospital	Ph:  262-928-7878
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Clinical Trials Office - Waukesha Memorial Hospital Regional Cancer Center	Ph:  262-928-7632
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Clinical Trials Office - University of Wisconsin Cancer Center	Ph:  608-262-5223
	Wisconsin Rapids
	Riverview UW Cancer Center at Riverview Hospital
		Ron Kirschling, MD, FACP	Ph:  715-421-7442
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
Israel
	Haifa
	Rambam Medical Center
		Jacob Rowe, MD	Ph:  972-4-854-2541

Registry Information
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
Trial Start Date		2008-02-29
Trial Completion Date		2009-08-24 (estimated)
Registered in ClinicalTrials.gov		NCT00602641
Date Submitted to PDQ		2008-01-03
Information Last Verified		2010-02-08
NCI Grant/Contract Number		CA21115

Back to Top