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A Phase 1 of JNS002 (Doxorubicin HCl Liposome Injection) in Combination With Bortezomib for Japanese Patients With Relapsed or Refractory Multiple Myeloma

Phase 1
20 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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).

Inclusion Criteria:

- Patients confirmed diagnosis of multiple myeloma with evaluable disease parameters
(1.Presence of M-protein in the serum and/or urine, 2.Increased plasma cells in the
bone marrow or biopsy-proven plasmacytoma, 3.Presence of related organ tissue

- Patients with progression of disease after an initial response (complete, partial, or
minimal response based on the EBMT criteria) to at least 1 line of therapy.
Progression of disease before responding to an initial line of therapy with a
non-anthracycline containing regimen that included (at a minimum) an alkylating agent
or high-dose corticosteroids. Rituximab alone or experimental agents alone were not
to be considered a line of therapy

- Patients with progressive disease as defined by one of the following: i) > 25%
increase in M-protein, ii) Development of new or worsening lytic bone lesions, iii)
Development of new or worsening plasmacytoma, iv) Development of new or worsening
hypercalcemia (> 11.5 mg/dL or 2.8 mmol/L corrected) that is not attributable to any
other cause

- Patients with measurable secretory disease defined as either: i) Serum monoclonal
protein > 1 g/dL, ii) Urine monoclonal (light chain) protein > 200 mg/24 hours

- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0
or 1. ECOG performance status score 2 due to pain associated with bone disorder is

Exclusion Criteria:

- Patients with history of treatment with bortezomib

- Patients with progressive disease while receiving an anthracycline-containing regimen

- Patients with no change (NC) in disease status during initial therapy (patient must
have had a response and then progression or progression while receiving initial
therapy [primary refractory disease]

- Patients with non-secretory disease (i.e., no measurable paraprotein in serum or

- urine paraprotein level = 200 mg/24 hours)

- Patients with prior treatment with doxorubicin or other anthracycline at cumulative
doses greater than 240 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg
doxorubicin = 1 mg JNS002 = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg

- Patients with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral
neuropathy, according to Common Terminology Criteria for Adverse Events (CTCAE)

- Patients with clinically significant heart disease, New York Heart Association (NYHA)
Class II or higher heart failure

- Patients with viral hepatitis or chronic liver disease

- Patients with pulmonary fibrosis or interstitial pneumonitis

Type of Study:


Study Design:

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

Outcome Measure:

Number of patients with adverse events as a measure of safety and tolerability

Outcome Time Frame:

Up to 21 days

Safety Issue:


Principal Investigator

Janssen Pharmaceutical K.K. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutical K.K.


Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Study ID:




Start Date:

April 2011

Completion Date:

May 2012

Related Keywords:

  • Multiple Myeloma
  • Relapsed or refractory multiple myeloma
  • JNS002
  • bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell