A Phase I/II Study of JNJ-26866138 (Bortezomib) in Japanese Patients With Relapsed or Refractory Multiple Myeloma
In Japan, there is no clear treatment guidance for patients with multiple myeloma that
repeatedly relapsed and became refractory. At present, various therapies including other
multi-drug combination chemotherapy, hematopoietic stem cell transplantation, corticosteroid
massive therapy, interferon therapy, thalidomide therapy, radiation therapy and other
experimental therapies are conducted exploratory as salvage therapies to find the one to
which the patient shows response. Considering that the antitumor activity of JNJ-26866138
against relapsed or refractory MM is clear and and the tolerability is acceptable based on
results of the overseas clinical studies, the development of JNJ-26866138 in Japan is quite
meaningful. This is a non-randomized, open-label, multicenter dose-escalation study which
consisting of the two parts: the Phase I part is intended to intravenously administer
JNJ-26866138 twice daily for 2 weeks (Days 1, 4, 8, and 11) to establish the Japanese RD
based on the incidence of dose limiting toxicities (DLTs), while the Phase II part is
intended to evaluate the efficacy and safety of JNJ-26866138 in patients repeatedly treated
at the Japanese RD.
Based on the body surface area calculated before treatment in each cycle, the dose is
calculated for each patient according to the dose level specified by the Patient Enrollment
Center (0.7mg/m2, 1.0 mg/m2 or 1.3 mg/m2). JNJ-26866138 is intravenously administered once
daily, twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period
(Days 12 to 21). This is considered one cycle (21 days), and treatment is repeated up to 6
cycles in patients expected to show a response.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To assess safety/tolerability and determine the Japanese RD of bortezomib. Phase II: part: To evaluate the efficacy and safety of bortezomib in patients repeatedly treated at the Japanese RD.
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center