Clincosm LogoSign in Get a demo

S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma

Sponsor
Southwest Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00005834
Collaborator
National Cancer Institute (NCI) (NIH)
19
Enrollment
93
Locations
2
Arms
91
Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

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 chemotherapy with DCEP administered every 8 weeks for 3 additional courses. Arm II: Patients receive chemotherapy with DCEP 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients With Refractory Multiple Myeloma
Study Start Date :
Apr 1, 2000
Actual Primary Completion Date :
Nov 1, 2003
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: chemo with thalidomide

chemo with thalidomide

Biological: filgrastim
Arms 1 and 2: 300 mcg (pts </= 60 kg) or 480 mcg (pts > 60 kg), SC beginning day 5
Other Names:
  • G-CSF

    • Drug: cisplatin
    Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4
    Other Names:
  • platinol

    • Drug: cyclophosphamide
    Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4
    Other Names:
  • cytoxan

    • Drug: dexamethasone
    Arms 1 and 2: 40 mg/d PO days 1-4
    Other Names:
  • decadron

    • Drug: etoposide
    Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4
    Other Names:
  • VP-16

    • Drug: thalidomide
    Arm 2: 800 mg/d (max dose) PO daily
    Other Names:
  • thalomid

    		•
    Active Comparator: chemo without thalidomide

    chemo without thalidomide

    Biological: filgrastim
    Arms 1 and 2: 300 mcg (pts </= 60 kg) or 480 mcg (pts > 60 kg), SC beginning day 5
    Other Names:
  • G-CSF

    • Drug: cisplatin
    Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4
    Other Names:
  • platinol

    • Drug: cyclophosphamide
    Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4
    Other Names:
  • cytoxan

    • Drug: dexamethasone
    Arms 1 and 2: 40 mg/d PO days 1-4
    Other Names:
  • decadron

    • Drug: etoposide
    Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4
    Other Names:
  • VP-16

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PFS [18 months]

      Length of time until progression - 25% increase from the baseline in myeloma protein production of other signs of disease progression such as hypercalcemia.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I, II, or III multiple myeloma with protein criteria present Quantifiable M-components of IgG, IgA, IgD, IgE AND/OR Urinary kappa or lambda light chain excretion No IgM peaks Quantifiable monoclonal proteins Received at least 1, but no more than 4 prior treatment regimens, including the following: Chemotherapy Bone marrow transplantation Biologic therapy Radiotherapy Interferon therapy or steroid pulsing given as maintenance therapy after transplantation or chemotherapy is not considered a separate treatment regimen Progressive disease

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 (3-4 allowed if due solely to bone pain) Life expectancy: At least 3 months 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 for 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 grade 2 or greater preexisting peripheral neuropathy

    PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior thalidomide allowed if received less 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - Gulf Coast Mobile Alabama United States 36688
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona United States 85012
    4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    5 Arizona Cancer Center Tucson Arizona United States 85724
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    8 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
    9 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    10 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    11 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
    12 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    13 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    14 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    15 Chao Family Comprehensive Cancer Center Orange California United States 92868
    16 University of California Davis Medical Center Sacramento California United States 95817
    17 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    18 David Grant Medical Center Travis Air Force Base California United States 94535
    19 University of Colorado Cancer Center Denver Colorado United States 80010
    20 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    21 Hematology Oncology Associates Atlantis Florida United States 33462
    22 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    23 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    24 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    25 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
    26 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
    27 CCOP - Central Illinois Decatur Illinois United States 62526
    28 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    29 Loyola University Medical Center Maywood Illinois United States 60153
    30 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    31 CCOP - Wichita Wichita Kansas United States 67214-3882
    32 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    33 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
    34 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    35 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    36 Tulane University School of Medicine New Orleans Louisiana United States 70112
    37 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
    38 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    39 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
    40 Boston Medical Center Boston Massachusetts United States 02118
    41 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    42 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    43 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    44 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    45 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    46 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    47 Henry Ford Hospital Detroit Michigan United States 48202
    48 CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    49 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
    50 CCOP - Duluth Duluth Minnesota United States 55805
    51 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    52 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    53 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    54 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    55 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
    56 CCOP - Kansas City Kansas City Missouri United States 64131
    57 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    58 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    59 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    60 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    61 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    62 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    63 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    64 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    65 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    66 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    67 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    68 CCOP - Columbus Columbus Ohio United States 43206
    69 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    70 CCOP - Dayton Kettering Ohio United States 45429
    71 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    72 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
    73 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
    74 Oregon Cancer Center Portland Oregon United States 97201-3098
    75 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    76 CCOP - Columbia River Program Portland Oregon United States 97213
    77 CCOP - Greenville Greenville South Carolina United States 29615
    78 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    79 Veterans Affairs Medical Center - Dallas Dallas Texas United States 75216
    80 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    81 University of Texas Medical Branch Galveston Texas United States 77555-0209
    82 Texas Tech University Health Science Center Lubbock Texas United States 79423
    83 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    84 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
    85 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    86 CCOP - Scott and White Hospital Temple Texas United States 76508
    87 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    88 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    89 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    90 Swedish Cancer Institute Seattle Washington United States 98104
    91 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    92 CCOP - Northwest Tacoma Washington United States 98405-0986
    93 Madigan Army Medical Center Tacoma Washington United States 98431-5000

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Mohamad A. Hussein, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00005834
    Other Study ID Numbers:
    • S9922
    • S9922
    • U10CA032102
    First Posted:
    Mar 16, 2004
    Last Update Posted:
    Mar 6, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Southwest Oncology Group
    refractory multiple myeloma
    stage I multiple myeloma
    stage II multiple myeloma
    stage III multiple myeloma
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Thalidomide
    Dexamethasone
    Cyclophosphamide
    Etoposide

    Study Results

    No Results Posted as of Mar 6, 2015