Clinical Trial: Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Southwest Oncology Group
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 tumor cells by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide for multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have refractory multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory plasma cell neoplasm
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: etoposide
 Drug: filgrastim
 Drug: thalidomide
Phase III

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin, and Filgrastim (G-CSF) With or Without Thalidomide in Patients With Refractory Multiple Myeloma

Further Study Details: 

Study start: April 2000

OBJECTIVES: I. Compare the overall and progression-free survival and remission rates in patients with refractory multiple myeloma treated with dexamethasone, cyclophosphamide, etoposide, cisplatin, and filgrastim (G-CSF) with or without thalidomide. II. Compare the qualitative and quantitative toxic effects of these regimens in these patients.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior transplantation (yes vs no), prior treatment failure (resistant vs relapsing), prior treatment regimens (1-2 vs 3-4), and prior thalidomide (no vs some). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral dexamethasone daily and cyclophosphamide, etoposide, and cisplatin (DCEP) IV continuously on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover. Treatment continues every 3-4 weeks for 3 courses. Patients achieving stable disease or better proceed to maintenance DCEP chemotherapy administered every 8 weeks for 3 additional courses. Arm II: Patients receive DCEP chemotherapy as in arm I plus oral thalidomide daily. Thalidomide continues with maintenance chemotherapy and then continues after chemotherapy is completed until disease progression. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: See Disease Characteristics; Prior thalidomide allowed if received no more than 3 months of therapy; Recovered from prior biologic therapy
  • Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy and recovered; No other concurrent chemotherapy
  • Endocrine therapy: See Disease Characteristics; No concurrent hormonal therapy
  • Radiotherapy: See Disease Characteristics; At least 3 weeks since prior extensive or limited radiotherapy and recovered; No concurrent radiotherapy
  • Surgery: Not specified

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Zubrod 0-2 (3-4 allowed if due solely to bone pain)
  • Life expectancy: Not specified
  • Hematopoietic: Absolute granulocyte count at least 1,000/mm3; Platelet count at least 50,000/mm3 (at least 50% plasma cells in bone marrow)
  • Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN
  • Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use 2 methods of effective contraception for 4 weeks before, during, and 4 weeks after study; No other prior or concurrent malignancies within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission; No preexisting peripheral neuropathy grade 2 or greater

Location Information


Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States

      Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix,  Arizona,  85012,  United States

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

      Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock,  Arkansas,  72205,  United States

California
      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  United States

      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States

      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      University of California Davis Medical Center, Sacramento,  California,  95817,  United States

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States

      Veterans Affairs Medical Center - Long Beach, Long Beach,  California,  90822,  United States

      Veterans Affairs Medical Center - West Los Angeles, Los Angeles,  California,  90073,  United States

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States

Florida
      Hematology Oncology Associates, Atlantis,  Florida,  33462,  United States

Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States

      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States

Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States

      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States

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

      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612-7323,  United States

      Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,  Illinois,  60141,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States

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

Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40511-1093,  United States

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States

      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71130,  United States

Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States

      Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain,  Massachusetts,  02130,  United States

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States

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

      CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids,  Michigan,  49503,  United States

      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States

      Providence Hospital - Southfield, Southfield,  Michigan,  48075-9975,  United States

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States

      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105,  United States

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States

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

Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

      Veterans Affairs Medical Center - Biloxi, Biloxi,  Mississippi,  39531-2410,  United States

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States

      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States

      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States

Ohio
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States

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

      CCOP - Dayton, Kettering,  Ohio,  45429,  United States

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

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

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428,  United States

Oklahoma
      Oklahoma Medical Research Foundation, Oklahoma City,  Oklahoma,  73104,  United States

      Veterans Affairs Medical Center - Oklahoma City, Oklahoma City,  Oklahoma,  73104,  United States

Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States

      Oregon Cancer Center, Portland,  Oregon,  97201-3098,  United States

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States

Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234,  United States

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

      Texas Tech University Health Science Center, Lubbock,  Texas,  79423,  United States

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States

      University of Texas Medical Branch, Galveston,  Texas,  77555-0209,  United States

      Veterans Affairs Medical Center - Dallas, Dallas,  Texas,  75216,  United States

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78284,  United States

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States

Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States

      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States

      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States

Study chairs or principal investigators

Mohamad Ahmed Hussein,  Study Chair,  Southwest Oncology Group   

More Information

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

Study ID Numbers:  CDR0000067848; SWOG-S9922
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005834
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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