S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory 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, refractory multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma (MM) Active disease Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation Relapse is defined as the occurrence of any of the following during or after prior treatment: Myeloma protein level increase by > 100% from the lowest previously recorded level Myeloma protein level increase above the defined response criteria for partial remission Reappearance of any myeloma peak that had disappeared during the prior treatment Increase in the size and number of lytic bone lesions and/or focal lesions by x-ray, MRI, positron emission tomography, and/or CT scan Refractory disease is defined as no response (i.e., not achieving complete remission, remission, or partial remission) to prior therapy Measurable disease No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome Must be registered on protocol SWOG-S0334 PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 (unless due to bone pain) Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count > 50,000/mm^3 Hepatic AST or ALT ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ 3 times ULN Renal Creatinine clearance > 30 mL/min Cardiovascular No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past 6 months No poorly controlled hypertension Other Not pregnant or nursing Negative pregnancy test Fertile female patients must use effective double method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for 4 weeks after completion of study treatment for male patients) No blood, ova, or sperm donation during study treatment No active infection requiring antibiotics No neurotoxicity ≥ grade 2 No diabetes mellitus No other serious medical or psychiatric illness that would preclude study treatment No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered Endocrine therapy Not specified Radiotherapy At least 14 days since prior radiotherapy and recovered Surgery Not specified Other No prior bortezomib alone or combined with thalidomide Concurrent participation on protocol SWOG-S0309 allowed
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Good Samaritan Regional Health Center
- Hematology Oncology Consultants - Naperville
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services, Incorporated
- Genesis Regional Cancer Center at Genesis Medical Center
- Genesis Medical Center - West Campus
- Tammy Walker Cancer Center at Salina Regional Health Center
- Wesley Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metro Health Hospital
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Holland Community Hospital
- Foote Hospital
- Sparrow Regional Cancer Center
- Hackley Hospital
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute - Saginaw
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- Saint Francis Medical Center
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic Cancer Center
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Tucker Center for Cancer Care at Orange Regional Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Pardee Memorial Hospital
- Rutherford Hospital
- Cleveland Clinic Taussig Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Community Oncology Group at Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cleveland Clinic - Wooster
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Tod Children's Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Legacy Meridian Park Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Center for Cancer Medicine and Blood Disorders, PA
- Brooke Army Medical Center
- Baylor University Medical Center - Houston
- Ben Taub General Hospital
- Methodist Hospital
- St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
- Veterans Affairs Medical Center - Houston
- Wilford Hall Medical Center
- CCOP - Scott and White Hospital
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Latter Day Saints Hospital
- Utah Cancer Specialists at UCS Cancer Center
- Danville Regional Medical Center
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
bortezomib with thalidomide and dexamethasone
bortezomib with thalidomide and dexamethasone