Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

This is an interventional other trial for Myeloma focused on measuring Pharmacogenomics, prediction response, prediction adverse event Read More

Inclusion Criteria:

• Understand and voluntarily sign an informed consent form
• Age ≥ 65 years at the time of signing consent

• Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all 3 required)

  • Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
  • Monoclonal protein present in the serum and/or urine

  • Myeloma-related organ dysfunction (at least one of the following):

    • Calcium elevation in the blood (serum calcium > 10.5 mg/l or upper limit of normal)
    • Renal insufficiency (serum creatinine > 2 mg/dl)
    • Anemia (hemoglobin < 10 g/dl or 2 g < normal)
    • Lytic bone lesions or osteoporosis

• have measurable disease by protein electrophoresis analyses as defined by the following:

  • IgG multiple myeloma: Serum monoclonal paraprotein (M-protein)level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 h
  • IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein level³ 200 mg/24 h
  • IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dL or urine Mprotein level ≥ 200 mg/24h
  • IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dL or urine M-protein level ≥ 200 mg/24h
  • Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dL or urine Mprotein level ≥ 200 mg/24 hours
• ECOG performance status of 0, 1, or 2
• Treated by either melphalan-prednisone-thalidomide or lenalidomide- dexamethasone

Exclusion Criteria:

• Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of randomization]
• Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study

• Any of the following laboratory abnormalities :

  • Absolute neutrophil count (ANC) < 1,000 cells/µL (1.0 x 109/L)
  • Platelet count < 50,000 cells/µL (50 x 109/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count < 30,000/µL for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
  • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
  • Creatinine clearance ≤ 30 mL/min (Cockroft-Gault calculation)

• Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:

  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
• Patients who have are unable or unwilling to undergo antithrombotic therapy
• Peripheral neuropathy of > grade 2 severity
• Known HIV positivity or active infectious hepatitis, type A, B, or C.
• Primary AL amyloidosis and myeloma complicated by amyloidosis.
• Renal failure requiring dialysis