Know Cancer

or
forgot password

An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma


Phase 2
20 Years
74 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma


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 treatment is strongly expected in such relapsed patients in Japan. This is a open
label multiple center study to evaluate the effectiveness and safety of bortezomib. This
study is an extension or re-treatment study for patients who were administered with
bortezomib in preceding Phase I/II study. For extension treatment, the same dose of the
previous study will be administered into a vein as a bolus twice weekly followed by a 10-day
rest (3-week cycle). For re-treatment, a recommended dose determined in Phase I/II study
will be administered in 3-week cycle.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Janssen Pharmaceutical K.K. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutical K.K.

Authority:

Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Study ID:

CR004843

NCT ID:

NCT00216697

Start Date:

March 2005

Completion Date:

October 2006

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Proteasome inhibitor
  • Ubiquitin
  • Boronic acids
  • Bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location