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

Expanded access is no longer available for this treatment.
(Company decision to cancel due to public funding)
Sponsor:
Collaborator:
Ortho Biotech Canada
Information provided by:
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT00799539
First received: November 26, 2008
Last updated: July 28, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: bortezomib
Drug: melphalan
Drug: prednisone
Phase 3

Study Type: Expanded Access     What is 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

Resource links provided by NLM:


Further study details as provided by Janssen-Ortho Inc., Canada:

Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799539

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Ortho Biotech Canada
Investigators
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada
  More Information

No publications provided

Responsible Party: VP, Medical & Government Affairs, Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier: NCT00799539     History of Changes
Other Study ID Numbers: CR015310, 26866138MMY3020
Study First Received: November 26, 2008
Last Updated: July 28, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Janssen-Ortho Inc., Canada:
Prednisone
Bortezomib
Melphalan

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

ClinicalTrials.gov processed this record on October 23, 2014