Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma

November 5, 2013 updated by: Oncotherapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93720
        • Hematology-Oncology Medical Group of Fresno, Incorporated
      • Orange, California, United States, 92868
        • Hematology Oncology Medical Group of Orange County, Incorporated
      • West Hollywood, California, United States, 90069
        • Oncotherapeutics
    • Florida
      • Bonita Springs, Florida, United States, 34135
        • Florida Cancer Specialists - Bonita Springs
      • Orange Park, Florida, United States, 32073
        • Florida Oncology Associates
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Atlanta Cancer Care - Roswell
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY downstate Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and tolerability as assessed by NCI CTCAE v3.0
Overall response rate (complete response [CR], near CR, partial response, and minimal response)
Proportion of patients responding
Time to disease progressionin patients receiving maintenance treatment

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Time to disease progression
Time to response
Overall survival as assessed by the Kaplan-Meier method

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncotherapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

April 24, 2006

First Submitted That Met QC Criteria

April 24, 2006

First Posted (Estimate)

April 25, 2006

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000479708
  • ONCOTHER-20052183
  • ONCOTHER-BAM2005
  • MILLENNIUM-ONCOTHER-20052183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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