Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone
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