A Study to Further Assess Safety and Effectiveness Data of the Bortezomib(Velcade)/Melphalan/Prednisone (BMP) Regimen in Previously Untreated and Transplant Ineligible Multiple Myeloma Patients

NCT00799539 | Unknown

• 2 other identifiers: CR01531026866138MMY3020
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

The primary reason for this study is to further assess safety and efficacy data of the bortezomib/melphalan/prednisone (BMP) regimen in previously untreated and transplant ineligible multiple myeloma patients

Conditions

Multiple Myeloma

Keywords

Prednisone; Bortezomib; Melphalan

Interventions

bortezomib DRUG

From cycles 1-4, 1.3mg/m\^2 on days 1,4,8,11,22,25,29,and 32 of each 6-week cycle

melphalan DRUG

9 mg/m\^2 once daily on days 1-4 of each 6-week cycle

prednisone DRUG

60 mg/m\^2 once daily on days 1-4 of each 6-week cycle

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is not a candidate for high-dose chemotherapy with stem cell transplant because of age of patient is 65 years or older, overall response in patients less than 65 years old -presence of important comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation. Sponsor review of these comorbid conditions and approval is required before enrollment
• Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage
• Presence of measurable disease (secretory multiple myeloma or oligosecretory or nonsecretory multiple myeloma)
• If female, the patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit
• If male, the patient agrees to use an acceptable barrier method for contraception from screening through the Final Visit
• Patient has a Karnofsky performance status \>60
• The subject meets the following pretreatment laboratory criteria at and within 14 days before baseline (Day 1 of Cycle 1, before study drug administration): a. platelet count \> = 100 x 10\^9/L, or \> = 70 x 10\^9/L if thrombocytopenia is considered by the investigator to be due to myeloma infiltration of bone marrow. b. hemoglobin \> = 80 g/L ( \> = 4.96 mmol/L) (prior RBC transfusion or recombinant human erythropoietin use is allowed). c. absolute neutrophil count (ANC) \> = 1.0 x 10\^9/L. d. aspartate aminotransferase (AST) \< = 2.5 times the upper limit of normal. e. alanine aminotransferase (ALT) \< = 2.5 times the upper limit of normal. f. serum creatinine \< = 2 mg/dL (= 176.8 mcmol/L). g. corrected serum calcium \< 14 mg/dL ( \< 3.5 mmol/L)

You may not qualify if:

• Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS)
• Diagnosis of Waldenström's disease or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
• Prior or current systemic therapy for multiple myeloma including steroids (with exception of emergency use of a short course \[maximum 4 days\] of steroids before randomization or of prior or current use of bisphosphonates)
• Radiation therapy within 30 days before enrollment
• Plasmapheresis within 30 days before enrollment
• Major surgery within 30 days before enrollment (Kyphoplasty is not considered major surgery)
• Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0
• Acute diffuse infiltrative pulmonary and pericardial disease
• Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead
• Ortho Biotech Canada: collaborator

Study Sites (3)

Unknown Facility

Burnaby, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

N/a N/a, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Melphalan; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; 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; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CA (3)