S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT00124579
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.
- Detailed Description
OBJECTIVES:
* Determine the confirmed overall response rate (complete remission, remission, and partial remission) in patients with relapsed or refractory multiple myeloma treated with bortezomib, thalidomide, and dexamethasone.
* Determine overall and progression-free survival of patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Correlate, preliminarily, treatment with bortezomib with the activation of osteoblasts in these patients.
OUTLINE: This is a multicenter study.
* Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral thalidomide once daily on days 1-21, and oral dexamethasone once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days until achievement of confirmed complete remission (CR), remission (R), or partial remission (PR) OR for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving confirmed CR, R, or PR who reach a plateau prior to receiving the maximum 8 courses of induction therapy OR who achieve confirmed CR, R, or PR after receiving the maximum 8 courses of induction therapy proceed to maintenance therapy. Patients achieving stable disease after receiving the maximum 8 courses of induction therapy either proceed to maintenance therapy or receive further treatment with bortezomib, thalidomide, and dexamethasone off-study.
* Maintenance therapy: Patients receive oral dexamethasone on days 1-4. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed within 30 days and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description bortezomib with thalidomide and dexamethasone bortezomib bortezomib with thalidomide and dexamethasone bortezomib with thalidomide and dexamethasone dexamethasone bortezomib with thalidomide and dexamethasone bortezomib with thalidomide and dexamethasone thalidomide bortezomib with thalidomide and dexamethasone
- Primary Outcome Measures
Name Time Method Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR). 1 year Responses are defined as follows:
Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.
Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein \< 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.
Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival about 12-18 months From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years
Toxicity Evaluation From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years To evaluate the qualitative and quantitative toxicities associated with this regimen.
Trial Locations
- Locations (126)
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
🇺🇸Southfield, Michigan, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Tod Children's Hospital
🇺🇸Youngstown, Ohio, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Cleveland Clinic - Wooster
🇺🇸Wooster, Ohio, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Sletten Regional Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
🇺🇸Martinsville, Virginia, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Woolley, Washington, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Foote Hospital
🇺🇸Jackson, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mount Vernon, Washington, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Hematology Oncology Consultants - Naperville
🇺🇸Naperville, Illinois, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Genesis Medical Center - West Campus
🇺🇸Davenport, Iowa, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Air Force Base, Ohio, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Community Oncology Group at Cleveland Clinic Cancer Center
🇺🇸Independence, Ohio, United States
Center for Cancer Medicine and Blood Disorders, PA
🇺🇸El Paso, Texas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States