Status:
COMPLETED
An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase I/II Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase I/II study. The other purpose is to evaluate the effectiveness a...
Detailed Description
Multiple myeloma is a kind of malignant disease in the organ which produce blood cells such as bone marrow. It has poor prognosis, especially in patients who are relapsed repeatedly. Effective treatme...
Eligibility Criteria
Inclusion
- Complete 6 cycles treatment in preceding phase I/II study
- response (CR, PR, MR or NC) was obtained in 6 cycles treatment during the preceding phase I/II study and investigator considers that the patient is expected to have benefit such as antitumor effect, pain relief or improvement of performance state
- Patients who did not have Grade \>=3 non-hematologic toxicity or Grade 4 hematologic toxicity during the preceding phase I/II study or extension treatment of this study
- Investigator considers that the patient is expected to have benefit of this drug such as antitumor effect, pain relief or improvement of performance state.
Exclusion
- Patient is known to be HBs antigen positive, HCV antibody positive or HIV antibody positive (check is required for patients who received blood product during phase I/II study)
- Patients who receive G-CSF product or blood transfusion within 7 days before the start of treatment
- Disease progress was observed during the phase I/II or this study when patients receive recommended dose
- Patients who suffer Grade \>=2 peripheral neuropathy or Grade \>=2 neuropathic pain
- Patient has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, acute ischemia or active conduction system abnormalities.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00216697
Start Date
March 1 2005
End Date
October 1 2006
Last Update
May 17 2011
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