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An Efficacy and Safety Study for Bortezomib in Patients Previously Treated for Multiple Myeloma With Limited Kidney Function
This study is not yet open for participant recruitment.
Verified by Janssen-Ortho Inc., Canada, December 2008
Sponsored by: Janssen-Ortho Inc., Canada
Information provided by: Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier: NCT00718640
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of bortezomib in patients previously treated for multiple myeloma with limited kidney function.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Drug: Dexmethasone
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy of VELCADE in Relapsed and/or Refractory Multiple Myeloma Patients With Impaired Renal Function

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

Primary Outcome Measures:
  • Assessment of safety, toxicity and tolerability Estimation of the proportion of renal-compromised multiple Myeloma patients who have received at least 1 prior line of therapy who respond to bortezomib treatment [ Time Frame: efficacy and safety will be assessed each cycle and the last measurement will take place at 30-45 days after the last dose of Velcade. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Best Response; Time to Progression; Duration of Response; Renal Function; Quality of Life; [ Time Frame: every three months for up to two years after the last dose of Velcade ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: bortezomib
1.3mg/m2 once daily on days 1,4,8,11 of eight 21 days cycles
Drug: Dexmethasone
20 mg/day on says 1, 2, 4, 5, 8, 9, 11, 12 of the 21 day cycles

Detailed Description:

Limited Kidney function is a condition that can result from high cancer burden on the body and can result in increased toxicity of anti-cancer treatment. The rationale for this open label study is to assess prospectively the safety and efficacy of bortezomib in renal-compromised patients with multiple myeloma. The study hypothesis is that the study drug will be safe and effective in treatment of previously-treated multiple myeloma patients with limited kidney function. The efficacy of bortezomib will be assessed by measuring serum M-protein and urine M-protein (monoclonal paraprotein) levels at the beginning of each treatment cycle before the injection of the study drug. Safety will be assessed by the monitoring of adverse events, physical examinations (including peripheral neurological examinations), vital sign measurements, hematology and serum biochemistry tests from the time the patient signs the informed consent form until the final /early termination visit. Patients will be treated with bortezomib for up to eight 21-day treatment cycles

Patients enrolled in the study will be treated with bortezomib for up to eight 21-day treatment cycles. The patients will receive intravenous injections of bortezomib on Days 1, 4, 8, and 11. The starting dose of bortezomib, which is also the standard dose in myeloma patients, will be 1.3 mg/m2.

  Eligibility

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

Inclusion Criteria:

  • Has received at least one previous line of therapy for multiple myeloma
  • Has a Karnofsky performance status >60
  • Calculated or measured creatinine clearance of =<30 mL/min
  • Has a Left Ventricular Ejection Fraction (LEF) >= 40%

Exclusion Criteria:

  • No history of allergic reaction attributable to compounds containing boron or mannitol
  • No peripheral neuropathy of Grade 2 or greater intensity at the time of signing informed consent form
  • No cardiac amyloidosis or suspected cardiac amyloidosis
  • No myocardial infarction within 6 months of enrolment
  • Not pregnant or breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718640

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email info1@veritasmedicine.com

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

Responsible Party: Janssen-Ortho Inc., Canada ( Senior Medical Director, Medical Affairs OB Canada )
Study ID Numbers: CR015082, 26866138MMY2052
Study First Received: July 17, 2008
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00718640  
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen-Ortho Inc., Canada:
Impaired Renal Function
Multiple Myeloma
Velcade
Bortezomib

Study placed in the following topic categories:
Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009