Randomized Study of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients

Shanghai Jiao Tong University School of Medicine

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: velcade

Study type

Interventional

Funder types

Other

Identifiers

NCT00984828

MMY3024

Details and patient eligibility

About

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 randomized into standard group which will receive a single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and the study group which will receive single autologous hematopoietic stem cell transplantation with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone as consolidation.

Full 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 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.

Enrollment

23 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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