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) (PORYOU)

This is an interventional treatment trial for Relapsed and/or refractorY Multiple Myeloma Read More

Inclusion Criteria:

• Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)

  • Serum M-protein ≥ 0.5g/dL, or
  • In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
• Patients were ineligible for autologous stem cell transplantation
• Must be relapse refractory to initial therapy with bortezomib, melphalan and prednison and then lenalidomide plus dexamethasone.
• Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
• Males and females ≥ 18 years of age or > country's legal age for adult consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

• Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:

  • Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
  • Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
  • Calculated creatinine clearance ≥ 30mL/min or creatinine < 3mg/dL.
• Written informed consent in accordance with federal, local and institutional guidelines

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