Bortezomib and Dexamethasone in Treating Patients With Multiple Myeloma That Has Relapsed or Has Not Responded to Treatment

Study Overview
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Brief Summary
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RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and 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 dexamethasone may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with dexamethasone works in treating patients with multiple myeloma that has relapsed or has not responded to treatment.

Detailed Description
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OBJECTIVES: Primary Determine the overall response rate (complete response and partial response) in patients with relapsed or refractory multiple myeloma treated with induction therapy and maintenance therapy comprising bortezomib and dexamethasone. Secondary Determine the toxicity of this regimen in these patients Determine the tolerability of this regimen in these patients. Determine the duration of response in patients treated with this regimen. Determine time to progression in patients treated with this regimen. Determine overall and progression-free survival of patients treated with this regimen. OUTLINE: This is an open-label study. Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 4 courses. Patients who achieve complete response (CR) receive an additional 2 courses of induction therapy and proceed to maintenance therapy. Maintenance therapy: Patients receive bortezomib IV on days 1, 8, 15, and 22. Patients also receive oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 36 days in the absence of disease progression or unacceptable toxicity. Patients who achieve CR receive an additional 2 courses of maintenance therapy beyond documentation of CR. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
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Phase II Trial of Twice Weekly Induction Followed by Once Weekly IV Velcade (Bortezomib) With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Following at Least 1 Prior Therapy

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Drug: bortezomib
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma Refractory or relapsed disease meeting the following criteria: Primary refractory disease and first-line relapsing disease Progressive disease after last therapy PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ for patients with significant bone marrow involvement) Transfusions allowed Hemoglobin ≥ 7.5 g/dL Absolute neutrophil count ≥ 750/mm³ Serum calcium < 14 mg/dL AST and ALT < 2.5 times upper limit of normal Creatinine clearance ≥ 30 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No peripheral neuropathy ≥ grade 2 within the past 14 days No hypersensitivity to boron or mannitol No cardiovascular complications, including any of the following: Myocardial infarction within the past 6 months New York Heart Association class III-IV heart failure Uncontrolled angina Ventricular arrhythmias Electrocardiographic evidence of acute ischemia or active conduction system abnormalities Cardiac amyloidosis No other cancer or treatment for cancer other than basal cell cancer of the skin within the past 5 years No poorly controlled chronic diseases (e.g., diabetes mellitus or hypertension) No HIV positivity No hepatitis B surface antigen or active hepatitis C infection No active systemic infection requiring therapy No serious medical or psychiatric illness that would interfere with study participation PRIOR CONCURRENT THERAPY: No plasmapheresis within the past 4 weeks No major surgery within the past 4 weeks No prior bortezomib No chemotherapy (e.g., clarithromycin) within the past 4 weeks No radiotherapy within the past 3 weeks No corticosteroids (> 10 mg/day of prednisone or equivalent) within the past 3 weeks No other immunotherapy within the past 8 weeks No other investigational drugs within the past 14 days No concurrent participation in other clinical research studies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bortezomib|nan|
|Drug: dexamethasone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Tolerability |  |  | 
| Duration of response after completion of treatment |  |  | 
| Time to progression |  |  | 
| Overall and progression-free survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma