A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients.
- Patient is, in the investigator's opinion, willing and able to comply with the
- 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consent may be withdrawn by the patient at any time without prejudice to their future
- Age over 65 years.
- Patient recently diagnosed with symptomatic Multiple Myeloma based on standard
criteria and that has not received any previous chemotherapy treatment for Multiple
- Patient has measurable disease, defined as follows:
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum
monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24
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 oligo-secretory multiple
myeloma, the serum and/or urine M-protein measurements are very low and difficult to
follow for response assessment. In patients with non-secretory multiple myeloma, there is
no M-protein in serum or urine.
- Patient has a Karnofsky performance status higher 60%.
- Patient has a life-expectancy >3 months.
- Patient has the following laboratory values within 14 days before Baseline visit (Day
1 of Cycle 1, before study drug administration:
Platelet count ≥ 100x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥
Corrected serum calcium < 14mg/dl. Aspartate transaminase (AST): ≤ 2.5 x the upper limit
of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total
bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine value ≤ 2mg/dl.
- Patient previously received treatment with Velcade.
- Patient previously received treatment for Multiple Myeloma.
- Patient had major surgery within 4 weeks before enrollment.
- Patient has a platelet count < 100 x 109/L within 14 days before enrollment.
- Patient has an absolute neutrophil count < 1.0 x 109/L within 14 days before.
- Patient has < Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Patient has received other investigational drugs within 14 days before enrollment.
- Patient is known to be seropositive for the human immunodeficiency virus (HIV),
Hepatitis B surface antigen-positive or active hepatitis C infection.
- Patient had a myocardial infarction within 6 months of enrollment or has New York
Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities.
Patient is enrolled in another clinical research study and/or is receiving an
investigational agent for any reason.