Status:
TERMINATED
Randomized Study of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then patients will be rand...
Detailed Description
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 inducti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00984828
Start Date
August 1 2009
End Date
December 1 2016
Last Update
September 8 2016
Active Locations (1)
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1
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China, 200025