A Study of JNS002 (Doxorubicin Hydrochloride Liposome Injection) in Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Bortezomib; Doxorubicin

Criteria

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 impairment)

• 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 eligible.

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

• 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 idarubicin)

• 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