A Study of JNS002 (Doxorubicin Hydrochloride Liposome Injection) in Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate tolerability of the combination therapy of JNS002 and bortezomib in Japanese bortezomib-naive patients with multiple myeloma who have ever received at least 1 line of chemotherapy.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 of JNS002 (Doxorubicin HCl Liposome Injection) in Combination With Bortezomib for Japanese Patients With Relapsed or Refractory Multiple Myeloma|
- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
- Number of subjects who achieved a complete response or partial response [ Time Frame: Up to 126 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
JNS002 30 mg/m2 by intravenous infusion at a rate of = 1 mg/minute on Day 4 of each 21-day cycle.
30 mg/m2 by intravenous infusion at a rate of = 1 mg/minute on Day 4 of each 21-day cycle.
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).