PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• •Patient is of a legally consenting age, as defined by local regulations.
• •Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
• •Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• •Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• •Male patient agrees to use an acceptable method for contraception for the duration of the study.
• •Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second-, third-, or fourth-line therapy because of PD, defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium \>11.5 mg/dL), or relapse from CR.
• •Patient has measurable disease, defined as follows:
• •For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, greater than 1 g/dL of IgG M-Protein and greater than 0.5g/dL IgA) and, where applicable, urine light-chain excretion of ≥200 mg/24 hours.
• •For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligosecretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessments. Therefore, other disease sites (bone marrow; extramedullary mass) must be assessed and followed. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine by immunofixation.
• •Patient has a Karnofsky performance status ≥60%.
• •Patient has a life-expectancy \>3 months.
• •Patient has the following laboratory values at and within 14 days before Baseline (Day 1 of Cycle 1, before study drug administration):
• •Platelet count ≥50 x 10E+9/L without transfusion support within 7 days before the laboratory test.
• •Hemoglobin ≥7.5 g/dL, without transfusion support within 7 days before the laboratory test.
• •Absolute neutrophil count (ANC) ≥0.75 x 10E+9/L without the use of colony stimulating factors.
• •Corrected serum calcium \<14 mg/dL (3.5 mmol/L).
• •Aspartate transaminase (AST): ≤2.5 x the upper limit of normal (ULN).
• •Alanine transaminase (ALT): ≤2.5 x the ULN.
• •Total bilirubin: ≤1.5 x the ULN.
• •Calculated or measured creatinine clearance: ≥20 mL/minute.