Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: pomalidomide; dexamethasone; rituximab
Intervention description: Taken orally once a day; Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15; Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Intervention MeSH terms: Dexamethasone; Rituximab; Pomalidomide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: WM; pomalidomide; dexamethasone; rituximab

Summary:

      Pomalidomide is a newly discovered drug that may stop cancer cells from growing abnormally.
      Pomalidomide may also stimulate the immune system to fight the cancer cells and possibly
      improve the effectiveness of dexamethasone and rituximab to fight the Waldenstrom's
      Macroglobulinemia (WM) cancer cells. This drug have been used in multiple myeloma and
      information from these other research studies suggests that Pomalidomide may help to reduce
      or prevent the growth of cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel
             criteria

          -  CD20 positive based on any previous performed bone marrow immunohistochemistry or flow
             cytometric analysis

          -  Meet criteria to treat based on consensus panel criteria

          -  Patient must have received at least one previous therapy for WM

          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study

          -  Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a
             minimum IgM level of 2 times (or greater) the upper limit of each institution's normal
             value is required

          -  ECOG Performance status of 0, 1 or 2

          -  Laboratory tests within ranges outlined in the protocol

          -  Disease free of prior malignancies for 5 years or more with exception of currently
             treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the
             cervix or breast

          -  Screening of patients at high risk of HBV or HCV infection

          -  Willing and able to take aspirin or alternate prophylactic anticoagulants

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness

          -  Pregnant or lactating females

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study

          -  Resistance or intolerance to prior rituximab therapy

          -  Previous therapy with thalidomide or lenalidomide

          -  Known hypersensitivity to thalidomide, lenalidomide or pomalidomide

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking similar drugs

          -  Concurrent use of other anti-cancer agents or treatments

          -  History of non-compliance to medical regimens

          -  Patients unwilling to or unable to comply with the protocol

          -  Known positive for HIV or hepatitis infection

          -  Any history of CVA (Cerebral Vascular Accident/stroke) or clots

          -  Active DVT or PE that has not been therapeutically anticoagulated

          -  NYHA classification III and greater heart failure

          -  Any patient that is unable to ingest or process pomalidomide