Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, amyloidosis, significant autoimmune, CNS or other malignant disease
POEMS syndrome
POEMS syndrome or active plasma cell leukemia;
POEMS syndrome requiring therapy, previously treated or untreated
POEMS syndrome
Diagnosed with plasma cell leukemia, POEMS syndrome or amyloidosis.
Plasma cell leukemia, primary amyloidosis or POEMS syndrome
POEMS syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis
Plasma cell leukemia, primary amyloidosis or POEMS syndrome
POEMS syndrome
Diagnosis of Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
Has known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of IXAZOMIB - Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
Multiple myeloma of IgM subtype, POEMS, plasma cell leukemia
Multiple myeloma of IgM subtype, POEMS, plasma cell leukemia
Waldenstrom’s macroglobulinemia: must have failed 2 courses of therapy
Waldenstrom’s macroglobulinemia or immunoglobulin (Ig)M myeloma
Waldenstrom’s macroglobulinemia or immunoglobulin M (IgM) myeloma
Clinicopathological diagnosis of Waldenstrom’s macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom’s macroglobulinemia (Kyle et al, 2003) or have high risk disease with an serum IgM level of 6,000 mg or higher (Gustine et al, 2016)
Clinicopathological diagnosis of Waldenstrom macroglobulinemia, and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom macroglobulinemia
Confirmed diagnosis of Marginal Zone Lymphoma or Waldenstroms Macroglobulinemia
Waldenstrom’s macroglobulinemia – must have failed 2 courses of therapy
Waldenstrom’s macroglobulinemia or IgM myeloma
PART I: Patients with Waldenstrom’s macroglobulinemia (WM) must meet the indications for treatment per the International Workshop on Waldenstrom’s Macroglobulinemia (IWWM)
PART IB: Patients with Waldenstrom’s macroglobulinemia (WM) must meet the indications for treatment per the International Workshop on Waldenstrom’s Macroglobulinemia (IWWM)
Waldenström’s macroglobulinemia
Waldenstrom's macroglobulinemia: must have failed 2 courses of therapy
Waldenstrom's macroglobulinemia
Clinicopathological diagnosis of Waldenstrom’s macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom’s macroglobulinemia
Clinicopathological diagnosis of Waldenstrom macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom macroglobulinemia or serum immunoglobulin M (IgM) > 6000 mg/dL and measurable disease
Waldenstrom's macroglobulinemia or immunoglobulin (Ig)M myeloma
Waldenstrom's macroglobulinemia must have failed 2 courses of therapy
Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM)
Waldenstrom's macroglobulinemia
Waldenstrom macroglobulinemia
Waldenstrom's Macroglobulinemia.
Waldenstrom macroglobulinemia
immunoplasmacytoma/immunocytoma (Waldenstrom's macroglobulinemia)
Clinicopathological diagnosis of Waldenstrom’s macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom’s macroglobulinemia
Waldenstrom’s macroglobulinemia – must have failed 2 courses of therapy
Waldenstrom's macroglobulinemia
Waldenstrom's macroglobulinemia.
STEP I: Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible
Subjects with only plasmacytomas, plasma cell leukemia, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), non-secretory myeloma or primarily amyloidosis.
Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma only
Subjects with second malignancies requiring active systemic therapy are excluded; subjects with second malignancies not requiring active systemic therapy or pre-malignant conditions such as monoclonal B-cell lymphocytosis (MBL) or monoclonal gammopathy of undetermined significance (MGUS) may be eligible
Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma
Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma
Monoclonal gammopathy of undetermined significance (MGUS), Waldenstrom’s macroglobulinemia, or asymptomatic (smoldering) myeloma
Patient has smoldering multiple myeloma or monoclonal gammopathy of unknown significance (MGUS).
Patients with stage I or smoldering myeloma, isolated plasmacytoma, or benign monoclonal gammopathy are not eligible
Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma
Patients with monoclonal gammopathy of undetermined significance are not eligible
Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum M-protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Diagnosed with smoldering MM, monoclonal gammopathy of undetermined significance, Waldenstrom macroglobulinemia, plasma cell leukemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome or amyloidosis
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational; prior therapy with bisphosphonate is allowed; prior radiation therapy to a solitary plasmacytoma is allowed; prior clinical trials or therapy for smoldering MM or monoclonal gammopathy of undetermined significance (MGUS) are allowed but should be discussed with the principal investigator
Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or plasma cell leukemia
Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS), Waldenstrom's macroglobulinemia, or smoldering myeloma
hyperviscosity syndrome due to monoclonal gammopathy
Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
Diagnosis of any monoclonal gammopathy: monoclonal gammopathy of undetermined significance (MGUS), asymptomatic / active multiple myeloma, asymptomatic / active Waldenstrom macroglobulinemia (WM)
POEMS (Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, or IgM myeloma.