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:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT02605356
Eligibility Criteria:
Inclusion Criteria:
* Cytologically or histologically confirmed diagnosis of multiple myeloma
* Subjects must have received at least 1 and not more than 3 previous lines of treatment and have had a response to treatment (i.e., achieved a minimal response \[MR\] or better) according to the International Myeloma Working Group (IMWG) uniform response criteria
* Subjects must have had progressive disease according to the IMWG uniform response criteria following the last multiple myeloma treatment
* Subjects must have measurable disease defined as at least 1 of the following (according to central laboratory results):
* Serum M-protein ≥1 g/dL
* Urine M-protein ≥200 mg/24 hours
* Serum free light chain (FLC) ≥10 mg/dL with abnormal ratio
* ≥1 bone lesion identifiable by radiograph, computed tomography, magnetic resonance imaging, or bone scintigraphy
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
* Subjects must be nonrefractory to bortezomib and had no progression during or within 60 days after completion of bortezomib
* Absolute neutrophil count (ANC) ≥1.5 × 10e9/L, hemoglobin (Hb) ≥9.0 g/dL, and platelet count ≥75.0 × 10e9/L independent of transfusion of red blood cells (RBC) or platelet concentrates and independent of granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF)
Exclusion Criteria:
* Systemic glucocorticoid therapy (prednisone \>10 mg/day orally or equivalent) within the last 4 weeks prior to first dose, unless tapered and on a stable dose ≤10 mg/day for at least 1 week
* Subjects with known POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or light chain (AL) amyloidosis
* Plasma cell leukemia
* Systemic anti-cancer therapy within 4 weeks prior to first dose
* Radiation therapy in the previous 4 weeks prior to first dose except if given for pain management and involves less than 10% of the bone marrow
* Prior treatment with radium-223 dichloride or any experimental radiopharmaceutical
* Congestive heart failure (New York Heart Association \[NYHA\] class III to IV), symptomatic cardiac ischemia, cardiomyopathy, clinically relevant ventricular arrhythmia, pericardial disease, unstable angina or myocardial infarct in the previous 6 months prior to first dose, left ventricular ejection fraction \<40%
* Neuropathy ≥ Grade 2 or Grade 1 with pain
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02605356
Study Brief:
Protocol Section:
NCT02605356