A Phase 1 of JNS002 (Doxorubicin HCl Liposome Injection) in Combination With Bortezomib for Japanese Patients With Relapsed or Refractory Multiple Myeloma
This is a non-randomized (study drug is intentionally assigned to the patient), single-arm
(one group of patients receiving the same treatment), open-label (all people involved know
the identity of the intervention) study to evaluate tolerability of the combination therapy
of JNS002 and bortezomib in 3 to 6 patients with multiple myeloma whose disease has either
progressed after at least 1 line of prior therapy or was refractory to initial treatment.
Initially, 3 patients will be enrolled and the incidence of dose limiting toxicity (DLT)
will be determined at the end of Cycle 1 to evaluate the study doses against the maximum
tolerated dose (MTD). If the incidence is =2/3, additional 3 patients will be enrolled to
define the MTD. Safety endpoints include adverse events, laboratory tests (hematology, blood
biochemistry, and urinalysis), electrocardiogram (ECG), LVEF, chest X-ray, vital signs (body
temperature, pulse rate, and blood pressure), and body weight. Efficacy evaluation will be
performed in terms of antitumor effect, according to criteria for assessment of antitumor
effect similar to the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Bortezomib 1.3 mg/m2 by rapid (bolus) intravenous (IV) administration will be given on Days
1, 4, 8, and 11 of each 21-day cycle. In addition, JNS002 30 mg/m2 by IV infusion will be
given at a rate of = 1 mg/minute on Day 4 of every 21-day cycle after bortezomib. Treatment
will continue for a total of 6 cycles of therapy (126 days).
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with adverse events as a measure of safety and tolerability
Up to 21 days
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center