Clinical Trial: Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

This study is currently recruiting patients.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

PURPOSE: This randomized phase III trial is studying lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: dexamethasone
 Drug: lenalidomide
 Drug: thalidomide
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: endocrine therapy
 Procedure: growth factor antagonist therapy
 Procedure: hormone therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: steroid therapy
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Lenalidomide With Standard-Dose Versus Low-Dose Dexamethasone With or Without Salvage Therapy Comprising Thalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Further Study Details: 

OBJECTIVES: Primary

  • Compare the response rate in patients with newly diagnosed multiple myeloma treated with lenalidomide and standard-dose vs low-dose dexamethasone.
  • Compare the toxicity of these regimens in these patients.

Secondary

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral lenalidomide once daily on days 1-21 and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20.
  • Arm II: Patients receive oral lenalidomide as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. In both arms, courses repeat every 28 days for up to 1 year in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 courses of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on arms I or II have the option to register on salvage therapy arms III or IV respectively.
  • Arm III (patients with no response after treatment on arm I): Patients receive oral thalidomide once daily on days 1-28 and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20.
  • Arm IV (patients with no response after treatment on arm II): Patients receive oral thalidomide as in arm III and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. In both salvage therapy arms, courses repeat every 28 days for up to 1 year in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 412 patients (206 per treatment arm) will be accrued for this study within 24 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma within the past 90 days, confirmed by the following criteria:
  • Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells OR biopsy-proven plasmacytoma within the past 4 weeks
  • Measurable monoclonal protein ≥ 1.0 g/dL by serum protein electrophoresis OR monoclonal light chain ≥ 200 mg by 24-hour urine protein electrophoresis within the past 4 weeks
  • Symptomatic disease
  • Prior plasmacytoma treated with curative-intent radiotherapy allowed provided disease progressed to active multiple myeloma
  • No smoldering myeloma
  • No monoclonal gammopathy of undetermined significance

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin > 7 g/dL
  • Platelet count > 75,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine < 2.5 mg/dL

Cardiovascular

  • No uncontrolled hypertension
  • No uncontrolled cardiac arrhythmia
  • No symptomatic congestive heart failure
  • No unstable angina
  • No prior or concurrent deep vein thrombosis

Pulmonary

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception (1 highly effective and one additional method) for 4 weeks prior, during, and for 4 weeks after completion of study treatment
  • No other active malignancy
  • Prior malignancy with a low expectation of recurrence within the next 6 months allowed
  • No prior Stevens Johnson syndrome
  • No active uncontrolled seizure disorder
  • No seizures within the past 6 months
  • No active uncontrolled infection
  • No uncontrolled psychiatric illness or social situation that would preclude study compliance
  • No peripheral neuropathygrade 2 due to other medical conditions
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

  • Not specified

Endocrine therapy

  • No prior glucocorticosteroid therapy for multiple myeloma
  • The following treatments for non-malignant disorders are allowed:
  • Prior systemic glucocorticosteroids
  • Prior or concurrent topical or localized glucocorticosteroids
  • Concurrent systemic glucocorticosteroids at a dose of ≤ 10 mg of prednisone per day (or equivalent)

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior palliative and/or localized radiotherapy

Surgery

  • Not specified

Other


Location and Contact Information


Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States; Recruiting
Contact Person  504-284-8430 

California
      Providence Saint Joseph Medical Center - Burbank, Burbank,  California,  91505,  United States; Recruiting
Raul R. Mena, MD  818-847-3220    raul.mena@providence.org 

Colorado
      Boulder Community Hospital, Boulder,  Colorado,  80301-9019,  United States; Recruiting
Eduardo R. Pajon, MD  303-440-2273    erpajon@aol.com 

      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States; Recruiting
Eduardo R. Pajon, MD  303-777-2663    erpajon@aol.com 

      Hope Cancer Care Center at Longmont United Hospital, Longmont,  Colorado,  80501,  United States; Recruiting
Eduardo R. Pajon, MD  303-651-5252    erpajon@aol.com 

      Medical Center of Aurora - South Campus, Aurora,  Colorado,  80012-0000,  United States; Recruiting
Eduardo R. Pajon, MD  303-368-2600    erpajon@aol.com 

      North Suburban Medical Center, Thornton,  Colorado,  80229,  United States; Recruiting
Eduardo R. Pajon, MD  303-451-7800 

      Penrose Cancer Center at Penrose Hospital, Colorado Springs,  Colorado,  80933,  United States; Recruiting
Eduardo R. Pajon, MD  719-776-5271    erpajon@aol.com 

      Porter Adventist Hospital, Denver,  Colorado,  80210,  United States; Recruiting
Eduardo R. Pajon, MD  303-778-1955    erpajon@aol.com 

      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States; Recruiting
Eduardo R. Pajon, MD  303-839-6000 

      Rose Medical Center, Denver,  Colorado,  80220,  United States; Recruiting
Eduardo R. Pajon, MD  303-320-7127    erpajon@aol.com 

      Sky Ridge Medical Center, Lone Tree,  Colorado,  80124,  United States; Recruiting
Eduardo R. Pajon, MD  720-220-1000    erpajon@aol.com 

      St. Joseph Hospital, Denver,  Colorado,  80218-1191,  United States; Recruiting
Eduardo R. Pajon, MD  303-837-7111    erpajon@aol.com 

      St. Mary-Corwin Regional Medical Center, Pueblo,  Colorado,  81004,  United States; Recruiting
Eduardo R. Pajon, MD  719-560-4000    erpajon@aol.com 

      Swedish Medical Center, Englewood,  Colorado,  80113,  United States; Recruiting
Eduardo R. Pajon, MD  303-788-5860    erpajon@aol.com 

Connecticut
      Praxair Cancer Center at Danbury Hospital, Danbury,  Connecticut,  06810,  United States; Recruiting
Robert B. Cooper, MD  203-792-5303    Robert.cooper@danhosp.org 

Florida
      Baptist Cancer Institute - Jacksonville, Jacksonville,  Florida,  32207-8554,  United States; Recruiting
Neil Abramson, MD  904-202-7051    abrm1h@bellsouth.net 

      Martin Memorial Cancer Center, Stuart,  Florida,  34994,  United States; Recruiting
Wendy Ryzner  772-223-5945 ext. 3718 

      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Contact Person  507-284-8430 

Georgia
      Augusta Oncology Associates, Augusta,  Georgia,  30901,  United States; Recruiting
Mark Robert Keaton, MD  706-736-1830 

      Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah,  Georgia,  31403-3089,  United States; Recruiting
Harvey C. Lebos, MD  912-350-3090 

Illinois
      Carle Clinic Association, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-3010 

      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      Joliet Oncology Hematology Associates, Limited - West, Joliet,  Illinois,  60435,  United States; Recruiting
Kendrith M. Rowland, MD  815-725-1355 

      Rush-Copley Cancer Care Center, Aurora,  Illinois,  60504-4206,  United States; Recruiting
Kendrith M. Rowland, MD  630-978-6200 

      Saint Anthony's Hospital at Saint Anthony's Health Center, Alton,  Illinois,  62002,  United States; Recruiting
Bethany G. Sleckman, MD  618-465-2571 

      Swedish-American Regional Cancer Center, Rockford,  Illinois,  61104-2315,  United States; Recruiting
Lori Kline, RN, BS  815-489-4413    lkline@swedishamerican.org 

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
Bilal Ansari, MD  574-647-7370 

      Center for Cancer Therapy at LaPorte Hospital and Health Services, LaPorte,  Indiana,  46350,  United States; Recruiting
Bilal Ansari, MD  219-326-1234 

      Elkhart General Hospital, Elkhart,  Indiana,  46514-1329,  United States; Recruiting
Bilal Ansari, MD  574-294-2621 

      Memorial Hospital of South Bend, South Bend,  Indiana,  46601,  United States; Recruiting
Bilal Ansari, MD  574-647-3431 

      Saint Anthony Memorial Health Centers, Michigan City,  Indiana,  46360-4358,  United States; Recruiting
Kendrith M. Rowland, MD  219-879-8511 

      St. Francis Hospital and Health Centers, Beech Grove,  Indiana,  46107,  United States; Recruiting
Howard M. Gross, MD  317-787-3311 

Iowa
      Alegent Health Community Memorial Hospital, Missouri Valley,  Iowa,  51555-1199,  United States; Recruiting
James A. Mailliard, MD  712-642-2784 

      Alegent Health Mercy Hospital, Council Bluffs,  Iowa,  51503,  United States; Recruiting
James A. Mailliard, MD  712-328-5000 

      Burgess Health Center, Onawa,  Iowa,  51040,  United States; Recruiting
James A. Mailliard, MD  712-423-2311 

      Cancer Center at Ottumwa Regional Health Center, Ottumwa,  Iowa,  52501,  United States; Recruiting
Roscoe F. Morton, MD, FACP  641-684-2300 

      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-244-7586 

      Covenant Medical Center, Waterloo,  Iowa,  50702,  United States; Recruiting
Mohammed T. Masri, MD  319-272-2070    masri66@aol.com 

      John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-663-5612 

      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-241-4245 

      McFarland Clinic, P.C., Ames,  Iowa,  50010,  United States; Recruiting
Joseph James Merchant, MD  515-239-4401    jjmerchant@mcfarlandclinic.com 

      Medical Oncology and Hematology Associates - West Des Moines, West Des Moines,  Iowa,  50266,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-244-7586 

      Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines,  Iowa,  50309,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-282-2921    rmorton@interserv.com 

      Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines,  Iowa,  50314,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-247-3970 

      Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines,  Iowa,  50314,  United States; Recruiting
Roscoe F. Morton, MD, FACP  515-247-3121 

      Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City,  Iowa,  50401,  United States; Recruiting
Walter W. Bate, MD  641-422-6320    batew@mercyhealth.com 

      Saint Anthony Regional Hospital, Carroll,  Iowa,  51401,  United States; Recruiting
James A. Mailliard, MD  712-792-3581 

      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Donald Bruce Wender, MD, PhD  712-252-0088    shoaresearch@shoa-research.org 

      St. Luke's Regional Medical Center, Sioux City,  Iowa,  51104,  United States; Recruiting
Donald Bruce Wender, MD, PhD  712-252-9326 

Maryland
      Cancer Center at Greater Baltimore Medical Center, Baltimore,  Maryland,  21204,  United States; Recruiting
Paul Celano, MD  443-849-3051    pcelano@gbmc.org 

Michigan
      Borgess Medical Center, Kalamazoo,  Michigan,  49001-1666,  United States; Recruiting
Raymond Sterling Lord, MD  616-383-7007 

      Bronson Methodist Hospital, Kalamazoo,  Michigan,  49007-5364,  United States; Recruiting
Raymond Sterling Lord, MD  616-341-8967 

      Mercy Memorial Hospital System, Monroe,  Michigan,  48162,  United States; Recruiting
Bilal Ansari, MD  734-240-8400 

      West Michigan Cancer Center, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  616-373-7488    rlord@wmcc.org 

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
S. Vincent Rajkumar, MD  507-284-2511    rajks@mayo.edu 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg6847@sprg.smhs.com 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
Jorge C. Paradelo, MD, FACR  816-823-0555    kccop@kccop.org 

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
Bethany G. Sleckman, MD  314-569-6573 

      Cox Medical Center North, Springfield,  Missouri,  65802,  United States; Recruiting
John Wendall Goodwin, MD  417-889-8099 

      David C. Pratt Cancer Center at St. John's Mercy, Saint Louis,  Missouri,  63141,  United States; Recruiting
Bethany G. Sleckman, MD  314-251-7057    slecbg@stlo.mercy.net 

      Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau,  Missouri,  63701,  United States; Recruiting
Bethany G. Sleckman, MD  573-651-5550 

      St. Francis Medical Center, Cape Girardeau,  Missouri,  63701,  United States; Recruiting
Bethany G. Sleckman, MD  573-331-5853 

Montana
      Benefis Healthcare Hospital, Great Falls,  Montana,  59405,  United States; Recruiting
Thomas Alan Warr, MD  406-455-5000 

      Big Sky Oncology, Great Falls,  Montana,  59405,  United States; Recruiting
Grant William Harrer, MD, FACP, CCRI  406-455-2820    drharrer@benefis.net 

      Bozeman Deaconess Hospital, Bozeman,  Montana,  59715,  United States; Recruiting
Patrick W. Cobb, MD  406-585-5000 

      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Patrick W. Cobb, MD  406-259-2245 

      Community Medical Center, Missoula,  Montana,  59801,  United States; Recruiting
Patrick W. Cobb, MD  406-728-4100 

      Deaconess Billings Clinic Cancer Center, Billings,  Montana,  59107-5100,  United States; Recruiting
Patrick W. Cobb, MD  406-238-5755 

      Eastern Montana Cancer Center, Miles City,  Montana,  59301,  United States; Recruiting
Patrick W. Cobb, MD  406-232-2666 

      Great Falls Clinic, Great Falls,  Montana,  59403,  United States; Recruiting
Thomas Alan Warr, MD  406-727-4584 

      Kalispell Regional Medical Center, Kalispell,  Montana,  59901,  United States; Recruiting
Patrick W. Cobb, MD  406-752-5111 

      Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula,  Montana,  59807,  United States; Recruiting
Patrick W. Cobb, MD  406-329-5655 

      Northern Rockies Radiation Oncology Center, Billings,  Montana,  59103,  United States; Recruiting
Patrick W. Cobb, MD  406-248-2212 

      St. James Community Hospital, Butte,  Montana,  59701,  United States; Recruiting
Patrick W. Cobb, MD  406-782-8361 

      St. Peter's Hospital, Helena,  Montana,  59601-4999,  United States; Recruiting
Patrick W. Cobb, MD  406-442-2480 

      St. Vincent Healthcare, Billings,  Montana,  59101,  United States; Recruiting
Patrick W. Cobb, MD  406-657-7000 

Nebraska
      Alegent Health - Immanuel Medical Center, Omaha,  Nebraska,  68122,  United States; Recruiting
James A. Mailliard, MD  402-572-2121 

      Bergan Mercy Medical Center, Omaha,  Nebraska,  68124,  United States; Recruiting
James A. Mailliard, MD  402-280-4364 

      Bryan LGH Medical Center - East, Lincoln,  Nebraska,  68506,  United States; Recruiting
Alan R. Berg, MD  402-484-4900 

      Bryan LGH Medical Center West, Lincoln,  Nebraska,  68502-3780,  United States; Recruiting
Alan R. Berg, MD  402-484-4900 

      Cancer Center at Creighton University Medical Center, Omaha,  Nebraska,  68131-2197,  United States; Recruiting
James A. Mailliard, MD  402-280-4367 

      Cancer Resource Center - Lincoln, Lincoln,  Nebraska,  68510-4844,  United States; Recruiting
Alan R. Berg, MD  402-483-2827 

      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

      Midlands Cancer Center at Midlands Community Hospital, Papillion,  Nebraska,  68128-4157,  United States; Recruiting
James A. Mailliard, MD  402-593-3000 

      St. Elizabeth Regional Medical Center, Lincoln,  Nebraska,  68510-2494,  United States; Recruiting
Alan R. Berg, MD  402-219-7700 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
John Allan Ellerton, MD, CM  702-384-0013    k.vanwagenen@sncrf.org 

      University Medical Center of Southern Nevada, Las Vegas,  Nevada,  89102-2386,  United States; Recruiting
John Allan Ellerton, MD, CM  702-383-2000 

New Jersey
      Booker Cancer Center at Riverview Medical Center, Red Bank,  New Jersey,  07701-9871,  United States; Recruiting
Denis B. Fitzgerald, MD  732-530-2382 

      Cancer Center at Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
Richard J. Rosenbluth, MD  201-569-3730 

      Somerset Medical Center, Somerville,  New Jersey,  08876,  United States; Recruiting
Hen-Vai Wu, MD  908-685-2481 

New York
      Comprehensive Cancer Center at Our Lady of Mercy Medical Center, Bronx,  New York,  10466-2604,  United States; Recruiting
Peter H. Wiernik, MD  718-920-1100    pwiernik@aol.com 

North Carolina
      Pardee Memorial Hospital, Hendersonville,  North Carolina,  28791,  United States; Recruiting
James E. Radford, MD  828-696-1000 

North Dakota
      Bismarck Cancer Center, Bismarck,  North Dakota,  58501-4445,  United States; Recruiting
Edward J. Wos, DO  701-222-6100 

      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States; Recruiting
Edward J. Wos, DO  701-323-5741    ejwos@mohs.org 

      Mid Dakota Clinic, P.C., Bismarck,  North Dakota,  58501,  United States; Recruiting
Edward J. Wos, DO  701-221-6000 

      St. Alexius Medical Center, Bismarck,  North Dakota,  58502,  United States; Recruiting
Edward J. Wos, DO  701-530-7000 

Ohio
      Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark,  Ohio,  43055-2899,  United States; Recruiting
J. Philip Kuebler, MD, PhD  740-348-1422 

      Adena Regional Medical Center, Chillicothe,  Ohio,  45601,  United States; Recruiting
J. Philip Kuebler, MD, PhD  740-779-7240 

      Akron City Hospital at Summa Health System, Akron,  Ohio,  44309-2090,  United States; Recruiting
Ralph Douglas Trochelman, MD  330-375-4221 

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-488-2118 

      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

      Charles F. Kettering Memorial Hospital, Kettering,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-395-8658 

      Community Hospital of Springfield and Clark County, Springfield,  Ohio,  45505,  United States; Recruiting
J. Philip Kuebler, MD, PhD  937-325-0531 

      Doctors Hospital at Ohio Health, Columbus,  Ohio,  43228,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-297-4000 

      Fairfield Medical Center, Lancaster,  Ohio,  43130,  United States; Recruiting
J. Philip Kuebler, MD, PhD  740-687-8000 

      Genesis - Good Samaritan Hospital, Zanesville,  Ohio,  43701,  United States; Recruiting
J. Philip Kuebler, MD, PhD  740-454-5000 

      Good Samaritan Hospital, Dayton,  Ohio,  45406-1891,  United States; Recruiting
Howard M. Gross, MD  937-278-2612 

      Grady Memorial Hospital, Delaware,  Ohio,  43015,  United States; Recruiting
J. Philip Kuebler, MD, PhD  740-368-5383 

      Grandview Hospital, Dayton,  Ohio,  45405,  United States; Recruiting
Howard M. Gross, MD  937-226-3200 

      Mercy Medical Center Oncology Unit, Springfield,  Ohio,  45501,  United States; Recruiting
J. Philip Kuebler, MD, PhD  513-390-5032 

      Miami Valley Hospital, Dayton,  Ohio,  45409,  United States; Recruiting
Howard M. Gross, MD  937-208-3463 

      Middletown Regional Hospital, Middletown,  Ohio,  45044-4898,  United States; Recruiting
Howard M. Gross, MD  513-424-2111 

      Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville,  Ohio,  43081,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-234-5433 

      Mount Carmel West Hospital, Columbus,  Ohio,  43222,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-234-5000 

      Riverside Methodist Hospital Cancer Care, Columbus,  Ohio,  43214-3998,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-566-4804 

      Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia,  Ohio,  45385,  United States; Recruiting
Howard M. Gross, MD  937-372-8011 ext. 5323 

      Samaritan North Cancer Care Center, Dayton,  Ohio,  45415,  United States; Recruiting
Howard M. Gross, MD  937-279-5800 

      St. Rita's Medical Center, Lima,  Ohio,  45801,  United States; Recruiting
Henry Gerad, MD  419-227-3361 

      Strecker Cancer Center at Marietta Memorial Hospital, Marietta,  Ohio,  45750-1635,  United States; Recruiting
J. Philip Kuebler, MD, PhD  740-376-5000 

      UVMC Cancer Care Center at Upper Valley Medical Center, Troy,  Ohio,  45373-1300,  United States; Recruiting
Howard M. Gross, MD  937-440-4820 

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Howard M. Gross, MD  937-268-6511 

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States; Recruiting
Willard G. Andrews, MD  215-481-2400 

      Albert Einstein Cancer Center, Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
Alan Lee Friedman, MD  215-969-6960    friedmaal@einstein.edu 

      Bryn Mawr Hospital, Bryn Mawr,  Pennsylvania,  19010,  United States; Recruiting
Paul B. Gilman, MD  610-526-3000    pgilman@pol.net 

      Cancer Center at Paoli Memorial Hospital, Paoli,  Pennsylvania,  19301-1792,  United States; Recruiting
Paul B. Gilman, MD  610-648-1600    pgilman@pol.net 

      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
Paul B. Gilman, MD  610-645-2494 

      Guthrie Medical Center - Sayre, Sayre,  Pennsylvania,  18840,  United States; Recruiting
Goran Broketa, MD  570-882-2141 

      Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Bernard A. Mason, MD  215-829-3000    bmason@pahosp.com 

      John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown,  Pennsylvania,  18105-1556,  United States; Recruiting
Eliot Lawrence Friedman, MD  610-402-0500    eliotl.friedman@lvh.com 

      Lankenau Cancer Center at Lankenau Hospital, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
Paul B. Gilman, MD  610-645-2000    pgilman@pol.net 

      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States; Recruiting
Terrence P. Cescon, MD  610-378-6193 

South Dakota
      Avera McKennan Hospital and University Health Center, Sioux Falls,  South Dakota,  57105-1080,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8000 

      Medical X-Ray Center, Sioux Falls,  South Dakota,  57105,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8000 

      Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8000 

Vermont
      Community Cancer Center at Rutland Regional Medical Center, Rutland,  Vermont,  05701,  United States; Recruiting
Allan D. Eisemann, MD  802-747-1831    aeiseman@rrmc.org 

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting
John Densmore, MD  434-924-9637    jjd2g@virginia.edu 

      Lynchburg Hematology-Oncology Clinic, Lynchburg,  Virginia,  24501,  United States; Recruiting
John Leach MacNeill, MD  434-947-5925 

Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
Thomas J. Saphner, MD  920-432-5134 

      Dean Medical Center, Madison,  Wisconsin,  53715,  United States; Recruiting
Charles H. Diggs, MD  608-252-8288 

      Fox Valley Hematology and Oncology, Appleton,  Wisconsin,  54911,  United States; Recruiting
John Dale Swanson, MD  920-749-1171 

      Green Bay Oncology, Limited - Oconto Falls, Oconto Falls,  Wisconsin,  54154,  United States; Recruiting
Thomas J. Saphner, MD  800-432-6049 

      Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay,  Wisconsin,  54235,  United States; Recruiting
Thomas J. Saphner, MD  800-432-6049 

      Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay,  Wisconsin,  54303,  United States; Recruiting
Thomas J. Saphner, MD  920-884-3135 

      Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse,  Wisconsin,  54601-5494,  United States; Recruiting
Robert S. Witte, MD  608-775-2749    rwitte@gundluth.org 

      Marshfield Clinic - Lakeland Center, Minocqua,  Wisconsin,  54548,  United States; Recruiting
Matthias Weiss, MD  715-358-1266    weiss.matthias@marshfieldclinic.org 

      Marshfield Clinic - Marshfield Center, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Matthias Weiss, MD  715-387-5511    weiss.matthias@marshfieldclinic.org 

      Oconomowoc Memorial Hospital, Oconomowoc,  Wisconsin,  53066,  United States; Recruiting
Federico A. Sanchez, MD  414-569-0669 

      Regional Cancer Center at Sacred Heart Hospital, Eau Claire,  Wisconsin,  54701,  United States; Recruiting
Matthias Weiss, MD  715-839-3956 

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States; Recruiting
Natalie Callander, MD  608-265-1700    nsc@medicine.wisc.edu 

      Waukesha Memorial Hospital Regional Cancer Center, Waukesha,  Wisconsin,  53188,  United States; Recruiting
Federico A. Sanchez, MD  262-928-2570    federico.sanchez@phci.org 

Wyoming
      Cancer Center of Northern Wyoming, Sheridan,  Wyoming,  82801,  United States; Recruiting
Patrick W. Cobb, MD  307-674-6022 

Study chairs or principal investigators

S. Vincent Rajkumar, MD,  Study Chair,  Mayo Clinic Cancer Center   
Rafael Fonseca, MD,  Mayo Clinic Scottsdale   
David H. Vesole, MD, PhD,  Medical College of Wisconsin   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000404161; ECOG-E4A03; NCT00098475
Record last reviewed:  March 2005
Last Updated:  April 5, 2005
Record first received:  December 7, 2004
ClinicalTrials.gov Identifier:  NCT00098475
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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