- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005834
S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Mobile, Alabama, United States, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, United States, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, United States, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Medical Center
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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Florida
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Atlantis, Florida, United States, 33462
- Hematology Oncology Associates
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Georgia
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Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, United States, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
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New York
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, United States, 45219
- Barrett Cancer Center, The University Hospital
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Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, United States, 45429
- CCOP - Dayton
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Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
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Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center
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South Carolina
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Texas
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Dallas, Texas, United States, 75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
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Galveston, Texas, United States, 77555-0209
- University of Texas Medical Branch
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Lubbock, Texas, United States, 79423
- Texas Tech University Health Science Center
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San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: chemo with thalidomide
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Arms 1 and 2: 300 mcg (pts 60 kg), SC beginning day 5
Other Names:
Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4
Other Names:
Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4
Other Names:
Arms 1 and 2: 40 mg/d PO days 1-4
Other Names:
Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4
Other Names:
Arm 2: 800 mg/d (max dose) PO daily
Other Names:
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Active Comparator: chemo without thalidomide
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Arms 1 and 2: 300 mcg (pts 60 kg), SC beginning day 5
Other Names:
Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4
Other Names:
Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4
Other Names:
Arms 1 and 2: 40 mg/d PO days 1-4
Other Names:
Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 18 months
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Length of time until progression - 25% increase from the baseline in myeloma protein production of other signs of disease progression such as hypercalcemia.
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18 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Mohamad A. Hussein, MD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Dexamethasone
- Cyclophosphamide
- Etoposide
- Cisplatin
- Thalidomide
Other Study ID Numbers
- S9922 (Other Identifier: SWOG)
- U10CA032102 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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