Status:
UNKNOWN
Sequential VAD and VTD Followed by HDT With ASCT and Velcade Maintenance for NDMM
Lead Sponsor:
Korean Multiple Myeloma Working Party
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
1. Primary Objective To assess the response rate of sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) induction therapy as a first line treatment fo...
Detailed Description
1. Overview of study design This study aims to assess the efficacy and toxicities of sequential VAD and VTD induction followed by high dose therapy with autologous stem cell transplantation and ma...
Eligibility Criteria
Inclusion
- Previously untreated newly diagnosed patients with MM (stage II-III) 2.Age \< 65 3.Eastern Cooperative Oncology Group Performance Status 0-1 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 (≥ 4.96 mol/L), Prior RBC transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (ANC) ≥ 1.0 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
- 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).
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2008
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00378755
Start Date
March 1 2006
End Date
July 1 2008
Last Update
September 22 2006
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744