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

NCT01371227 | Completed Phase 1

• 2 other identifiers: CR018085JNS002-JPN-03
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Relapsed or refractory multiple myeloma; JNS002; Bortezomib

Outcome Measures

Primary Outcomes (1)

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

  Up to 21 days

Secondary Outcomes (1)

• Number of subjects who achieved a complete response or partial response

  Up to 126 days

Study Arms (1)

JNS002

EXPERIMENTAL

JNS002 30 mg/m2 by intravenous infusion at a rate of = 1 mg/minute on Day 4 of each 21-day cycle.

Drug: JNS002

Interventions

JNS002 DRUG

30 mg/m2 by intravenous infusion at a rate of = 1 mg/minute on Day 4 of each 21-day cycle.

JNS002

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (2)

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Okayama, Japan

Location

Related Publications (1)

• Kusumoto S, Sunami K, Inagaki M, Iida S. Phase I study of pegylated liposomal doxorubicin in combination with bortezomib for Japanese patients with relapsed or refractory multiple myeloma. Int J Hematol. 2015 Jun;101(6):578-84. doi: 10.1007/s12185-015-1773-5. Epub 2015 Mar 7.

  PMID: 25749662 DERIVED

Related Links

• A Phase I Study of JNS002 (doxorubicin HCl liposome injection) in Combination with Bortezomib for Japanese Subjects with Relapsed or Refractory Multiple Myeloma

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 10, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 4, 2013

Record last verified: 2013-07

Locations

JP (2)