A Randomized Study of 4 vs. 8 Cycles of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients
18 Years
65 Years
Both
Multiple Myeloma
Trial Information
A Randomized Study of 4 vs. 8 Cycles of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients
The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old.
Newly-diagnosed myeloma patient enrolled will receive 4 cycles of velcade and Dexamethasone
as front-line induction therapy. All patients finished the induction therapy will be
randomized into standard group and the study group. All patients will mobilized by
cyclophosphamide with G-CSF to collect a target of 2x106 CD34+/kg and then undergo
autologous stem cell transplantation. For standard group, patients will receive single
auto-SCT with standard conditioning of melphalan 200mg/m2. The patients in the study group
will receive single auto-SCT with conditioning of melphalan 200mg/m2 added with 4 dose of
velcade at 1.0mg/m2 during the transplantation procedure and then followed by 3 more cycles
of velcade alone as consolidation.
Inclusion Criteria:
- Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem
cell transplantation is considered appropriate
- Measurable serum and/or urinary paraprotein
- European Cooperative Oncology Group performance status 0-3
- Serum bilirubin < 1.5x the upper limit of normal (ULN) Serum alanine transaminase
(ALT)/aspartate transaminase values < 2.5 x ULN
- Subjects (or their legally acceptable representatives) must signed an informed
consent document indicating that they understanding the purpose of and procedures
required for the study and are willing to participate in the study
Exclusion Criteria:
- Woman of child bearing potential
- Non-secretory MM
- Serum creatinine > 400 Micromol/l after initial resuscitation patients with previous
Grade 2-4 peripheral neuropathy
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable
dose for at least 3 months before first dose of study drug)
- Uncontrolled or severe cardiovascular disease including myocardial infarction within
6 months of enrollment, uncontrolled angina, clinically significant pericardial
disease, or III-IV heart failure
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
60 days and 2 years after the treatment
Safety Issue:
No
Principal Investigator
Zhi-Xiang Shen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Authority:
China: Ethics Committee
Study ID:
MMY3024
NCT ID:
NCT00984828
Start Date:
August 2009
Completion Date:
September 2014
Related Keywords:
- Multiple Myeloma
- multiple myeloma
- autologous stem cell transplantation
- velcade
- Multiple Myeloma
- Neoplasms, Plasma Cell
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