Status:
COMPLETED
Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Oncotherapeutics
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 grow...
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 pat...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00317811
Start Date
November 1 2005
Last Update
November 6 2013
Active Locations (8)
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1
Hematology-Oncology Medical Group of Fresno, Incorporated
Fresno, California, United States, 93720
2
Hematology Oncology Medical Group of Orange County, Incorporated
Orange, California, United States, 92868
3
Oncotherapeutics
West Hollywood, California, United States, 90069
4
Florida Cancer Specialists - Bonita Springs
Bonita Springs, Florida, United States, 34135