A Phase I/II Clinical Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
This is a phase 1/2, open-label (both physician and patient know the treatment will be
administered), non-randomized, multi-center study in untreated multiple myeloma. This study
consists of two portions, phase 1 portion and phase 2 portion. The objectives of this study
is to assess the safety, to establish the recommended dose, to evaluate pharmacokinetic
parameters (absorption, distribution, elimination,etc.) of bortezomib in the phase 1
portion, and to assess the efficacy and safety of the recommended dose of bortezomib in the
phase 2 portion. Primary outcome measure is response rate (percentage of patients achieved a
complete response or a partial response after the treatment) of the combination of
bortezomib, melphalan and prednisolone in patients with untreated multiple myeloma.
Administration method for bortezomib and combination drugs are as follows: Bortezomib will
be administered intravenously on day 1, 4, 8, 11, 22, 25, 29 and 32 followed by a 10-day
rest period of 6 weeks. With 6 weeks regarded as one cycle, treatment can be repeated for
up to 4 cycles. At the 5th or later cycles, bortezomib will be administered intravenously
on day 1, 8, 22, and 29 followed by a 13-day rest period of 6 weeks. With 6 weeks regarded
as one cycle, treatment can be repeated for up to 9 cycles. Melphalan and prednisolone will
be administered orally on day 1, 2, 3 and 4 followed by a 38-day rest period of 6 weeks.
With the 6 weeks regarded as one cycle, treatment can be repeated for up to 9 cycles. Safety
evaluation in this study includes adverse event reporting (all through the trial), vital
signs examination and laboratory tests (Cycle 1 to 4: day 1, 4, 8, 11, 22, 25, 29, 32 and 42
of 6-week cycle, Cycle 5 to 9: day 1, 4, 8, 22, 29 and 42 of 6-week cycle). Dosage of
bortezomib are 0.7, 1.0 and 1.3 mg/m2 in the phase I portion and either of the dose will be
selected as recommended dose in the phase 2 portion. Bortezomib will be administered
intravenously with 6-week cycle for up to 9 cycles. Melphalan 9mg/m2 and prednisolone
60mg/m2 will be administered orally with 6-week cycle for up to 9 cycles.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1: Select a recommended dose of bortezomib based upon safety evaluation. Phase 2: Determine response rate of the combination of bortezomib, melphalan and prednisolone in patients with untreated multiple myeloma.
After 9 cycles
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center