Last updated on February 2018

Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Subject must have documented monoclonal plasma cells as defined by their institutional
    tandard in the bone marrow >=10% at some point in their disease history or presence
    of a biopsy proven plasmacytoma
    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
    Subject must be non-refractory to bortezomib or another proteasome inhibitor (PI),
    like ixazomib and carfilzomib (Refractory is defined: progression of disease while
    receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another
    PI therapy, like ixazomib and carfilzomib)
    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 defined by the following:
    IgG multiple myeloma: Serum monoclonal paraprotein (M protein) level ≥1.0
    IgA, IgD, IgE, IgM multiple myeloma: serum M-protein level ≥0.5 g/dL
    Urine M-protein ≥200 mg/24 hours (any immunoglobulin heavy chain type)
    Serum free light chain (FLC) ≥10 mg/dL with abnormal ratio
    ≥1 bone lesion identifiable by radiograph, computed tomography, positron emission
    tomography - computed tomography (PET CT), or magnetic resonance imaging (MRI)
    Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
    Adequate hepatic function, with bilirubin ≤1.5 x upper limit of normal (ULN), and
    aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN
    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)
    International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5
    x ULN. PT can be used instead of INR if ≤ 1.5 x ULN

You may not be eligible for this study if the following are true:

  • 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 (prednisone
    ≤10 mg/day orally or equivalent) 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
    Subject has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic
    half-lives of the treatment, whichever is longer, before the date of randomization. A
    list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is
    provided in the Site Investigational Product Procedures Manual (IPPM).
    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),
    ymptomatic 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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