Newly Diagnosed Multiple Myeloma
Conditions
Interventions
Drug: velcade
Sponsors
Ochanomizu blood study committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Previously untreated newly diagnosed patients with MM (stage II-III) 2.Age 15-65 3.Eastern Cooperative Oncology Group Performance Status 0-2 4.EF > 50%, FVC and FEV > 50%, DLCO >50% 5.Platelet count 100 x 109/L (pretreatment platelet transfusion is not allowed, while transfusion during the treatment is permitted), hemoglobin 8 g/dL (Prior RBC transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (ANC) 1.5 x 109/L 6.Adequate liver function (bilirubin < UNL(Upper Normal Limit) x 2 and ALT/AST < UNL x 3) 7.Adequate renal function (serum creatinine < UNL x 1.5 or creatine clearance > 60 ml/min) 8.Signed the informed consent, have the will and ability to follow the protocol.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction attributable to compounds containing boron or mannitol 2. Known hypersensitivity to thalidomide or dexamethasone 3. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 4. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 5. Acute severe infection requiring antibiotic therapy 6. Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin) 7. Pregnancy or breastfeeding 8. Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion) 9. Previous renal transplantation 10. Recurrent deep vein thrombosis or pulmonary embolism 11. Uncontrolled diabetes mellitus 12. Receipt of extensive radiation therapy within 4 weeks ((Extensive means RT to more than 2 anatomic sites).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the response rate of patients given sequential VAD and VD induction followed by high dose therapy with autologous stem cell transplantation 2.To assess the toxicities of sequential VAD and VD induction chemotherapy, high dose therapy with autologous stem cell transplantation | — |
Countries
Japan
Contacts
Public Contactkazuteru ohashi
Tokyo Metroplolitan Komagome Hospital Hematology Division
Outcome results
None listed