Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT01371227
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01371227
Study Brief:
Protocol Section:
NCT01371227