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

NCT00317811 | Completed Phase 2

• 4 other identifiers: CDR0000479708ONCOTHER-20052183ONCOTHER-BAM2005MILLENNIUM-ONCOTHER-20052183
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 8

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Time to response

• Progression-free survival

• Overall survival as assessed by the Kaplan-Meier method

• Time to disease progression

Interventions

ascorbic acid DIETARY_SUPPLEMENT

bortezomib DRUG

melphalan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oncotherapeutics: lead

Study Sites (8)

Hematology-Oncology Medical Group of Fresno, Incorporated

Fresno, California, 93720, United States

Location

Hematology Oncology Medical Group of Orange County, Incorporated

Orange, California, 92868, United States

Location

Oncotherapeutics

West Hollywood, California, 90069, United States

Location

Florida Cancer Specialists - Bonita Springs

Bonita Springs, Florida, 34135, United States

Location

Florida Oncology Associates

Orange Park, Florida, 32073, United States

Location

Atlanta Cancer Care - Roswell

Roswell, Georgia, 30076, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Related Publications (1)

• 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.

  PMID: 19226361 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Ascorbic Acid; Bortezomib; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• James R. Berenson, MD

  Oncotherapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 25, 2006
• Study Start: November 1, 2005
• Primary Completion: February 1, 2009
• Last Updated: November 6, 2013

Record last verified: 2011-06

Locations

US (8)