Status:
TERMINATED
Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to test the safety and effectiveness of replacing vincristine with a drug called bortezomib (also known as "Velcade"or PS341) in the standard therapy vincristine,...
Detailed Description
Bortezomib, has been approved for use in patients with multiple myeloma, who have already received at least one prior treatment and whose disease is worsening on their last treatment and who have alre...
Eligibility Criteria
Inclusion
- Relapsed or refractory multiple myeloma following 1 previous line of therapy and, is scheduled by the investigator to be treated with vincristine, adriamycin and dexamethasone standard therapy
- measurable secretory multiple myeloma based on defined criteria
- Karnofsky performance status of \>or = 60%
- fulfils defined laboratory requirements within 14 days before baseline
- if female, the patient is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control for defined period of time
- if male, the patient agrees to use an acceptable barrier method for contraception for a defined period of time.
Exclusion
- More than one previous line of therapy for multiple myeloma
- use of bortezomib in the previous line of therapy and/or received bortezomib in a previous trial
- known allergy or hypersensitivity to bortezomib, boron or mannitol
- peripheral neuropathy or neuropathic pain of grade 2 or higher
- myocardial infarction within 6 months of enrollment or had New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00441168
Start Date
December 1 2006
End Date
January 1 2008
Last Update
March 21 2014
Active Locations (16)
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1
Zagreb, Croatia
2
Leer, Germany
3
Velbert, Germany
4
Debrecen, Hungary