VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates
VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates
Multiple Myeloma is a incurable disease. Recently developed targeted therapy gave new hope
 for the patients with multiple myeloma. Velcade in combination with other agents are
 currently in trials for the newly diagnosed patient, we designed sequential treatment with
 VTD and MPT for the patients who are not transplant candidates. This would be expected to
 result in maximal tumor control, and thus, in maximal survival benefit, equivalent to high
 dose therapy with autologous transplantation in younger population
The two effective and non-cross resistant regimens, VTD and MPT, will be applied sequentially
 to the patients with multiple myeloma who are not transplant candidates. This would be
 expected to result in maximal tumor control, and thus, in maximal survival benefit,
 equivalent to high dose therapy with autologous transplantation in younger population
Inclusion Criteria:

 -  Newly diagnosed patients with overt multiple myeloma who are not candidates for
 HDT/SCT because of old age (> 65) or presence of comorbid conditions likely to have a
 negative impact on tolerability of HDT/SCT. Sponsors review this conditions and
 approval is required.

 -  Presence of measurable disease : serum M-protein > 1g/dL or urine M- protein >
 400mg/day

 -  Performance status £ ECOG 2

 -  Expected survival ³ 6 months

 -  Pretreatment clinical laboratory values meeting the following criteria within 14 days
 before enrollment platelet ≥ 100 x 109/L hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L) Prior RBC
 transfusion or recombinant human erythropoietin use is allowed) absolute neutrophil
 count (ANC) ≥ 1.0 x 109/L aspartate aminotransferase (AST) ≤ 2.5 times the upper limit
 of normal alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal total
 bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤ 3mg/dL corrected
 serum calcium <14 mg/dL (<3.5 mmol/L)

 -  Subjects (or their legally acceptable representatives) must have signed an informed
 consent document indicating that they understand the purpose of and procedures
 required for the study and are willing to participate in the study.

 Exclusion Criteria:

 -  Smoldering or indolent myeloma

 -  History of allergic reaction attributable to compounds containing boron or mannitol

 -  Known hypersensitivity to thalidomide or dexamethasone

 -  Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE
 version 3

 -  Uncontrolled or severe cardiovascular disease, including MI within 6 months of
 enrolment, New York Heart Association (NYHA) Class III or IV heart failure,
 uncontrolled angina, clinically significant pericardial disease, or cardiac
 amyloidosis, cardiac ejection fraction <0.5 : Severe conduction disorder : Hypotension
 (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg

 -  Sepsis

 -  Pregnancy or breastfeeding

 -  Uncontrolled Diabetes Mellitus

 -  Recurrent DVT or pulmonary embolism

 -  Active ulcers detected by gastroscopy

 -  Serious medical or psychiatric illness likely to interfere with participation in this
 clinical study.

 -  Receipt of extensive radiation therapy within 4 weeks