search
Back to results

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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ascorbic acid
bortezomib
melphalan
Sponsored by
Oncotherapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hematology-Oncology Medical Group of Fresno, Incorporated
  • Hematology Oncology Medical Group of Orange County, Incorporated
  • Oncotherapeutics
  • Florida Cancer Specialists - Bonita Springs
  • Florida Oncology Associates
  • Atlanta Cancer Care - Roswell
  • University of Chicago Cancer Research Center
  • SUNY Downstate Medical Center

Outcomes

Primary Outcome Measures

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
Time to disease progressionin patients receiving maintenance treatment

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2006
Last Updated
November 5, 2013
Sponsor
Oncotherapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT00317811
Brief Title
Bortezomib, Ascorbic Acid, and Melphalan in Treating Patients With Newly Diagnosed Multiple Myeloma
Official Title
A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Oncotherapeutics

4. Oversight

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
ascorbic acid
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Type
Drug
Intervention Name(s)
melphalan
Primary Outcome Measure Information:
Title
Overall response rate (complete response [CR], near CR, partial response, and minimal response)
Title
Safety and tolerability as assessed by NCI CTCAE v3.0
Title
Proportion of patients responding
Title
Time to disease progressionin patients receiving maintenance treatment
Secondary Outcome Measure Information:
Title
Time to response
Title
Progression-free survival
Title
Overall survival as assessed by the Kaplan-Meier method
Title
Time to disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R. Berenson, MD
Organizational Affiliation
Oncotherapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology-Oncology Medical Group of Fresno, Incorporated
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Hematology Oncology Medical Group of Orange County, Incorporated
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Oncotherapeutics
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Florida Cancer Specialists - Bonita Springs
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Facility Name
Florida Oncology Associates
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Atlanta Cancer Care - Roswell
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19226361
Citation
Berenson JR, Yellin O, Woytowitz D, Flam MS, Cartmell A, Patel R, Duvivier H, Nassir Y, Eades B, Abaya CD, Hilger J, Swift RA. Bortezomib, ascorbic acid and melphalan (BAM) therapy for patients with newly diagnosed multiple myeloma: an effective and well-tolerated frontline regimen. Eur J Haematol. 2009 Jun;82(6):433-9. doi: 10.1111/j.1600-0609.2009.01244.x. Epub 2009 Feb 17.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs