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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vel 8 - ASCT

8 cycles of velcade with ASCT

Group Type EXPERIMENTAL

velcade

Intervention Type DRUG

velcade 1.3mg/m2 D1, 4, 8 and 11

vel4 - ASCT

4 cycles of velcade with ASCT

Group Type ACTIVE_COMPARATOR

velcade

Intervention Type DRUG

velcade 1.3mg/m2 D1, 4, 8 and 11

Interventions

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velcade

velcade 1.3mg/m2 D1, 4, 8 and 11

Intervention Type DRUG

Other Intervention Names

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bortezomib

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No