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A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma


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.

OUTLINE: This is an open-label study.

- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral
melphalan and oral ascorbic acid on days 1-4. Treatment repeats every 28 days to
maximum response [MR] or for at least 8 courses in the absence of disease progression
or unacceptable toxicity. Patients with responding disease receive an additional 2
courses of induction therapy beyond MR and proceed to maintenance therapy. Patients
with stable disease or without a maximum reduction in their paraprotein after 8 courses
of induction therapy are eligible to receive maintenance therapy.

- Maintenance therapy: Patients receive bortezomib IV on days 1 and 15. Treatment repeats
every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete response [CR], near CR, partial response, and minimal response)

Safety Issue:

No

Principal Investigator

James R. Berenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncotherapeutics

Authority:

United States: Federal Government

Study ID:

CDR0000479708

NCT ID:

NCT00317811

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
SUNY Downstate Medical CenterBrooklyn, New York  11203
Florida Oncology AssociatesOrange Park, Florida  32073
OncotherapeuticsLos Angeles, California  90067
Hematology-Oncology Medical Group of Fresno, IncorporatedFresno, California  93720
Hematology Oncology Medical Group of Orange County, IncorporatedOrange, California  92868
Atlanta Cancer Care - RoswellRoswell, Georgia  30076
Florida Cancer Specialists - Bonita SpringsBonita Springs, Florida  34135