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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00799539
Expanded Access Status : No longer available (Company decision to cancel due to public funding)
First Posted : December 1, 2008
Last Update Posted : December 2, 2015
Ortho Biotech Canada
Information provided by (Responsible Party):
Janssen-Ortho Inc., Canada

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

Condition or disease Intervention/treatment
Multiple Myeloma Drug: bortezomib Drug: melphalan Drug: prednisone

  Show Detailed Description

Study Type : Expanded Access
Official Title: An International Single-Arm Study to Provide Further Safety and Efficacy Data on the Bortezomib(Velcade)/Melphalan/Prednisone Regimen in Previously Untreated Transplant Ineligible Multiple Myeloma Patients

Intervention Details:
  • Drug: bortezomib
    From cycles 1-4, 1.3mg/m^2 on days 1,4,8,11,22,25,29,and 32 of each 6-week cycle
  • Drug: bortezomib
    From cycles 5-9, 1.3mg/m^2 on days 1, 8, 22, and 29 of each 6-week cycle
  • Drug: melphalan
    9 mg/m^2 once daily on days 1-4 of each 6-week cycle
  • Drug: prednisone
    60 mg/m^2 once daily on days 1-4 of each 6-week cycle

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00799539

Canada, British Columbia
Burnaby, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
N/a N/a, Canada
Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Ortho Biotech Canada
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada

Responsible Party: Janssen-Ortho Inc., Canada Identifier: NCT00799539     History of Changes
Other Study ID Numbers: CR015310
26866138MMY3020 ( Other Identifier: Janssen-Ortho, Canada )
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Janssen-Ortho Inc., Canada:

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors