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

This study has been terminated.
(Very slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00984828
First received: September 23, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: velcade
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of 4 vs. 8 Cycles of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Response rate [ Time Frame: 60 days and 2 years after the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vel 8 - ASCT
8 cycles of velcade with ASCT
Drug: velcade
velcade 1.3mg/m2 D1, 4, 8 and 11
Other Name: bortezomib
Active Comparator: vel4 - ASCT
4 cycles of velcade with ASCT
Drug: velcade
velcade 1.3mg/m2 D1, 4, 8 and 11
Other Name: bortezomib

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984828

Locations
China
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Zhi-Xiang Shen, M.D. Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
  More Information

No publications provided

Responsible Party: Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT00984828     History of Changes
Other Study ID Numbers: MMY3024
Study First Received: September 23, 2009
Last Updated: March 18, 2014
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
multiple myeloma
autologous stem cell transplantation
velcade

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014