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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
Not Enrolling
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



- 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.


- 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


- 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


- Karnofsky performance status 60-100%

- Life expectancy > 3 months

- Platelet count ≥ 50,000/mm³ (30,000/mm³ if the bone marrow is extensively

- 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

- No electrocardiographic evidence of acute ischemia or new conduction system

- 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


- 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:


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:


Principal Investigator

James R. Berenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Federal Government

Study ID:




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



University of Chicago Cancer Research Center Chicago, Illinois  60637
SUNY Downstate Medical Center Brooklyn, New York  11203
Florida Oncology Associates Orange Park, Florida  32073
Oncotherapeutics Los Angeles, California  90067
Hematology-Oncology Medical Group of Fresno, Incorporated Fresno, California  93720
Hematology Oncology Medical Group of Orange County, Incorporated Orange, California  92868
Atlanta Cancer Care - Roswell Roswell, Georgia  30076
Florida Cancer Specialists - Bonita Springs Bonita Springs, Florida  34135