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.
Related Research Topics
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Trial Locations
- Locations (126)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Hematology Oncology Consultants - Naperville
🇺🇸Naperville, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Genesis Medical Center - West Campus
🇺🇸Davenport, Iowa, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Scroll for more (116 remaining)Arkansas Cancer Research Center at University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States