Multiple Myeloma Clinical Trial
Official title:
An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma
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 and safety of patients who are re-treated with this drug in recommended dose.
Status | Completed |
Enrollment | 13 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 74 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutical K.K. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | No. of patients who had adverse events, incidence and severity of adverse events, and relationship to the study drug. Overall response rate (Complete Remission + Partial Remission). Response will be evaluated by independent review committee. | |||
Secondary | TTP (Time To Progression), survival time, time to response and duration of response. For re-treatment patients, survival time from the previous study drug treatment and response rate from the start of re-treatment will be also evaluated. |
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