Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma

Inclusion Criteria

• •Subject must voluntarily sign and understand written informed consent.
• •Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is detailed in Appendix I.
• •Measurable disease as defined the following:
• •1. For patients post induction therapy, any measurable paraprotein in the serum or urine and/or any plasmacytoma present on physical exam or imaging.
• •2. For patients with relapsed/refractory disease, \> 0.5 g/dL serum monoclonal protein, \> 0.1 g/dL serum free light chains, \> 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
• •Age \> or = than 18 years at the time of signing the informed consent form.
• •Karnofsky performance status\> or =70% (\>60% if due to bony involvement of myeloma).
• •Group A (post-induction therapy)- patients who have received only one prior treatment regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having received a Revlimid based regimen or Group B(\>1st line of therapy)- patients with relapsed/refractory multiple myeloma who have received two or more prior treatment regimens .
• •If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study and must use effective contraception throughout the course of the study.
• •Life expectancy \> 12 weeks.
• •Absolute neutrophil count (ANC)\> or = 1500 cells/mm3 (\> or = 1000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma)
• •Platelets count \> or = 50,000/mm3 (\> or = 30,000 for patients with bone marrow biopsy displaying \> 50% involvement by myeloma)
• •Hemoglobin \> 9.0 g/dL
• •Serum SGOT/AST \<3.0 x upper limits of normal (ULN)
• •Serum SGPT/ALT \<3.0 x upper limits of normal (ULN)
• •Serum creatinine \< 2.5 mg/dL or creatinine clearance \> 40ml/min
• •Serum total bilirubin \< 1.5 x ULN
• •Patients must have a MUGA scan with LVEF \>50%