The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM)

Exclusion Criteria

• •Female patients who are lactating or pregnant
• •Multiple Myeloma of IgM subtype
• •Glucocorticoid therapy (prednisolone \> 30mg/day or equivalent) within 14 days prior to informed consent obtained
• •POEMS syndrome, plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L, Waldenstrom's Macroglobulinaemia, or Patients with known amyloidosis
• •Peripheral neuropathy grade \> 2
• •Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting pomalidomide treatment
• •Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide
• •Immunotherapy (excluding steroids) 21 days prior to start of pomalidomide
• •Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide
• •Active congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
• •Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
• •Second malignancy within the past 3 years except:
• •* Adequately treated basal cell or squamous cell skin cancer
• •* Carcinoma in situ of the cervix
• •* Breast carcinoma in situ with full surgical resection
• •Patients with steroid or lenalidomide hypersensitivity
• •Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting pomalidomide treatment
• •Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent