Clinical Trial: Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

This study is no longer recruiting patients.

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

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: dexamethasone
 Drug: pamidronate
 Drug: thalidomide
 Drug: zoledronate
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: growth factor antagonist therapy
 Procedure: hypercalcemia therapy
 Procedure: supportive care/therapy
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Dexamethasone With or Without Thalidomide in Patients With Newly Diagnosed Multiple Myeloma

Further Study Details: 

OBJECTIVES:

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

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 194 patients (97 per treatment arm) will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed symptomatic multiple myeloma confirmed by the following:
  • Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis
  • Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis
  • No smoldering myeloma or monoclonal gammopathy of undetermined significance

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 50,000/mm^3
  • Hemoglobin greater than 7 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine less than 3 mg/dL

Cardiovascular:

  • No prior or concurrent deep venous thrombosis

Other:

  • Prior malignancy allowed provided the following criteria are met:
  • Received prior treatment with curative intent
  • Free of disease for the time period appropriate for cure of the specific cancer
  • No grade 2 or greater peripheral neuropathy due to other medical conditions
  • No active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • No prior biologic therapy for multiple myeloma
  • No other concurrent biologic therapy for multiple myeloma

Chemotherapy:

Endocrine therapy:

Radiotherapy:

Surgery:

  • Not specified

Other:

  • No prior systemic therapy for multiple myeloma, except bisphosphonates
  • No concurrent anticoagulant therapy for deep vein thrombosis
  • No concurrent barbiturates or alcohol (thalidomide arm)

Location Information


Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States

      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States

      Veterans Affairs Medical Center - Palo Alto, Palo Alto,  California,  94304-1290,  United States

Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80224,  United States

Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States

District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States

      UF Shands Cancer Center, Gainesville,  Florida,  32610-0277,  United States

      Veterans Affairs Medical Center - Gainesville, Gainesville,  Florida,  32608-1197,  United States

      Veterans Affairs Medical Center - Miami, Miami,  Florida,  33125,  United States

      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States

      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States

      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States

      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611-4494,  United States

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States

      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States

      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States

Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States

      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States

      Hematology Oncology Associates of the Quad Cities, Bettendorf,  Iowa,  52722,  United States

      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States

Kansas
      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States

Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States

      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States

      Tuft-New England Medical Center, Boston,  Massachusetts,  02111,  United States

Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States

      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417-2399,  United States

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States

      Veterans Affairs Medical Center - Omaha, Omaha,  Nebraska,  68105,  United States

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States

New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08903,  United States

      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States

      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07019,  United States

New York
      Albert Einstein Clinical Cancer Center, Bronx,  New York,  10461,  United States

      James P. Wilmot Cancer Center, Rochester,  New York,  14642,  United States

      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States

      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

      Veterans Affairs Medical Center - Brooklyn, Brooklyn,  New York,  11209,  United States

      Veterans Affairs Medical Center - New York, New York,  New York,  10010,  United States

North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States

Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States

      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States

      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States

Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States

      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States

      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States

      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213-3489,  United States

      Veterans Affairs Medical Center - Pittsburgh, Pittsburgh,  Pennsylvania,  15240-0001,  United States

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States

Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6307,  United States

      Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville,  Tennessee,  37212-2637,  United States

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

Wisconsin
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States

      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States

      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226-3596,  United States

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States

      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705-2286,  United States

      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States

Puerto Rico
      MBCCOP - San Juan, San Juan,  00927-5800,  Puerto Rico

      Veterans Affairs Medical Center - San Juan, San Juan,  00927-5800,  Puerto Rico

South Africa
      Pretoria Academic Hospitals, Pretoria,  0001,  South Africa

Study chairs or principal investigators

S. Vincent Rajkumar, MD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

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

Study ID Numbers:  CDR0000069274; E-E1A00
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  April 9, 2002
ClinicalTrials.gov Identifier:  NCT00033332
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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