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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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 and safety of patients who are re-treated with this drug in recommended dose.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Bortezomib

Criteria

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.