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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
This study has been terminated.
( Slower than anticipated recruitment and stopping criteria defined in protocol resulted in early termination of study. )
First Received: November 26, 2008   Last Updated: August 6, 2009   History of Changes
Sponsor: Janssen-Ortho Inc., Canada
Collaborator: Ortho Biotech Canada
Information provided by: Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier: NCT00799539
  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: prednisone
Drug: melphalan
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
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:

Primary Outcome Measures:
  • To further assess safety and efficacy data of the bortezomib/melphalan/prednisone (BMP) regimen in previously untreated and transplant ineligible multiple myeloma patients. [ Time Frame: M protein will be measured every 3 weeks for the duration of the study (54 weeks). Adverse events will be collected from the signed of the Informed Consent Form to 30-42 days after last study dose. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary objectives are to assess neurotoxicity using the FACT/GOG-Ntx questionnaire, and to capture investigator reported time to progression (TTP) data. [ Time Frame: FACT/GOG-Ntx questionnaire will be collected every cycle (q 6 weeks), and investiagator reported time to prgoression (TTP) data will be collected every 6 months after study termintation for a period of 2 years. ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: bortezomib
From cycles 5-9, 1.3mg/m^2 on days 1, 8, 22, and 29 of each 6-week cycle
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
002 Drug: prednisone
60 mg/m^2 once daily on days 1-4 of each 6-week cycle
Drug: melphalan
9 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
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: Janssen-Ortho Inc., Canada ( VP, Medical & Government Affairs )
Study ID Numbers: CR015310, 26866138MMY3020
Study First Received: November 26, 2008
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00799539     History of Changes
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Melphalan
Prednisone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Blood Protein Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Bortezomib
Vascular Diseases
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010