NCT00317811CompletedPhase 2
A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
Oncotherapeutics16 sites in 1 country35 target enrollmentStarted: November 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 16
- Primary Endpoint
- Time to disease progressionin patients receiving maintenance treatment
Study Overview
Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help melphalan work better by making cancer cells more sensitive to the drug. Giving bortezomib together with ascorbic acid and melphalan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with ascorbic acid and melphalan works in treating patients with newly diagnosed multiple myeloma.
Detailed Description
OBJECTIVES:
Primary
- Determine the overall response rate (combined complete response [CR], near CR, partial response [PR], and minimal response [MR]) and time to progression of disease in patients with newly diagnosed multiple myeloma treated with bortezomib, ascorbic acid, and melphalan.
- Assess the safety and tolerability of this regimen in these patients.
Secondary
- Assess the time to response in these patients.
- Determine progression-free and overall survival of these patients.
- Assess time to disease progression among subjects who continue to maintenance treatment with bortezomib.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed symptomatic multiple myeloma based on the following criteria:
- •Durie-Salmon staging
- •Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
- •Symptomatic disease
- •No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein], and skin changes)
- •No plasma cell leukemia
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Life expectancy > 3 months
- •Platelet count ≥ 50,000/mm³ (30,000/mm³ if the bone marrow is extensively infiltrated)
- •Hemoglobin ≥ 8.0 g/dL
- •Absolute neutrophil count ≥ 1,000/mm³
- •Creatinine ≤ 3 mg/dL
- •Sodium > 130 mmol/L corrected
- •AST and ALT ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 2 times ULN unless clearly related to the disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Any ECG abnormality has to be documented by the investigator as not medically relevant
- •No electrocardiographic evidence of acute ischemia or new conduction system abnormalities
- •No myocardial infarction or EKG evidence of infarction within the past 6 months
- •No active infection
- •No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL [3.5 mmol/L])
- •No New York Heart Association class III or IV heart failure
- •No uncontrolled angina
- •No severe uncontrolled ventricular arrhythmias
- •No active conduction system abnormalities
- •No poorly controlled hypertension
- •No diabetes mellitus
- •No known HIV infection
- •No known active hepatitis B or C viral infection
- •No history of grand mal seizures
- •No history of allergic reaction to compounds of similar chemical or biological composition to melphalan, bortezomib, boron, or mannitol
- •No peripheral neuropathy ≥ grade 2 within the past 14 days
- •No other serious medical or psychiatric illness that could potentially interfere with the completion of study treatment
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior immunotherapy, antibody therapy, or radiotherapy
- •More than 4 weeks since prior major surgery
- •No prior therapy for myeloma
- •Prior prednisone at a total of 400mg over ≤ 4 days (or an equivalent potency of another steroid) allowed
- •No concurrent corticosteroids (≥ 10 mg prednisone/day or equivalent)
- •No other concurrent investigational agents
- •No other concurrent antimyeloma therapy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time to disease progressionin patients receiving maintenance treatment
Overall response rate (complete response [CR], near CR, partial response, and minimal response)
Safety and tolerability as assessed by NCI CTCAE v3.0
Proportion of patients responding
Secondary Outcomes
- Time to response
- Progression-free survival
- Time to disease progression
- Overall survival as assessed by the Kaplan-Meier method
Investigators
Study Sites (16)
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