Velcade®, Thalidomide, Dexamethasone (VTD) Induction Therapy Followed By Melphalan, Prednisone, Thalidomide (MPT) Maintenance As a First Line Treatment For The Patients With Multiple Myeloma Who Are Non-Transplant Candidates
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