S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed multiple myeloma requiring treatment Smoldering myeloma with evidence of progressive disease requiring chemotherapy More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development Non-secretory patients with at least 30% bone marrow plasmacytosis No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions PATIENT CHARACTERISTICS: Age 18 to 65 Performance status Zubrod 0-2 OR Zubrod 3-4 based solely on bone pain Life expectancy Not specified Hematopoietic No untreated, unresolved symptomatic hyperviscosity Hepatic Hepatitis B negative Renal Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after hydration and/or correction of hypercalcemia) Cardiovascular No history of chronic cerebrovascular accident No myocardial infarction within the past 6 months No unstable angina No congestive heart failure that is difficult to control No uncontrollable hypertension No cardiac arrhythmia that is difficult to control Pulmonary No history of chronic obstructive or chronic restrictive pulmonary disease No untreated, unresolved pneumonia Pulmonary function tests (PFTs) at least 50% of predicted DLCO at least 50% of predicted Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to bone pain or fracture Other HIV negative No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No untreated, unresolved pathologic fractures Not pregnant or nursing Negative pregnancy test Fertile patients must use at least 2 highly effective methods of contraception for 4 weeks before, during, and for at least 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy No more than 8 weeks of prior thalidomide therapy Chemotherapy No prior chemotherapy for this disease Endocrine therapy Prior steroid therapy allowed provided treatment duration was no more than 2 weeks Radiotherapy No prior radiotherapy to more than 50% of the pelvis Surgery Not specified
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- University of California Davis Cancer Center
- Sutter Roseville Medical Center
- Sutter Cancer Center
- Piedmont Hospital
- CCOP - Atlanta Regional
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- OnCare Hawaii, Incorporated - Kuakini
- St. Francis Medical Center
- Kapiolani Medical Center for Women and Children
- St. Luke's Mountain States Tumor Institute - Boise
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- St. Francis Hospital and Health Centers
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Salina Regional Health Center
- Stormont-Vail Cancer Center
- St. Francis Comprehensive Cancer Center
- Wesley Medical Center
- Louisiana State University Health Sciences Center - Monroe
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County General Hospital
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Mercy Medical Center
- Spectrum Health Cancer Care - Butterworth Campus
- Metropolitan Hospital
- Holland Community Hospital
- Hackley Hospital
- Northern Michigan Hospital
- Munson Medical Center
- University of Mississippi Medical Center
- CCOP - Kansas City
- CCOP - Montana Cancer Consortium
- Deaconess Billings Clinic - Downtown
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Internal Medicine Associates of Bozeman
- St. James Community Hospital
- Big Sky Oncology
- Great Falls Clinic
- Sletten Regional Cancer Institute
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Montana Cancer Specialists at Montana Cancer Center
- Judy L. Schmidt, MD, FACP, P. C.
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Rutherford Hospital
- Comprehensive Cancer Center at Wake Forest University
- McDowell Cancer Center at Akron General Medical Center
- Adena Regional Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Grady Memorial Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- MedCentral - Mansfield Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center Oncology Unit
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- United States Air Force Medical Center Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Cancer Institute at Oregon Health and Science University
- Legacy Meridian Park Hospital
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- Bon Secours St. Francis Health System
- Greenville Hospital System Cancer Center
- CCOP - Greenville
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- CCOP - Upstate Carolina
- Thompson Cancer Survival Center
- Brooke Army Medical Center
- Wilford Hall Medical Center
- UMC Southwest Cancer and Research Center
- Auburn Regional Center for Cancer Care
- St. Joseph Hospital Community Cancer Center
- Olympic Hematology and Oncology
- Regional Cancer Center at Providence Hospital
- St. Francis Hospital
- Skagit Valley Hospital Cancer Care Center
- Providence St. Peter Hospital Regional Cancer Center
- Capital Medical Center
- Good Samaritan Cancer Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Harborview Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Allenmore Hospital
- CCOP - Northwest
- St. Joseph Medical Center at Franciscan Health System
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Central Washington Hospital
- Wenatchee Valley Clinic
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Welch Cancer Center
Arms of the Study
Arm 1
Experimental
treatment arm
thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance