A Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD)

Inclusion Criteria:

• History of histologically documented MM with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
• Patient has measurable disease in which to capture response.
• Performance status of 2 as per Zubroid scale, unless PS of 3-4 based solely on bone pain.
• Patients must have a platelet count 75,000/μL, and an ANC of at least 1,000/μL.
• Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dL.
• Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
• Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Male or female adults of at least 18 years of age.
• Patients must have signed an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.

Exclusion Criteria:

• Chemotherapy or radiotherapy received within the previous 2 weeks.
• Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria (See Appendix).
• Platelet count < 75,000/mm3, or ANC < 1,000/μl.
• Clinically significant hepatic dysfunction as noted by bilirubin or AST > 3 times the upper normal limit or clinically significant concurrent hepatitis.
• New York Hospital Association (NYHA) Class III or Class IV heart failure.
• Myocardial infarction within the last 6 months.
• Uncontrolled, active infection requiring IV antibiotics.
• Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
• Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
• Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method.
• Breast-feeding women may not participate.