Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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%
