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Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Suspended
CT.gov ID
NCT00892346
Collaborator
(none)
80
Enrollment
1
Location
1
Arm
103
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The clinical trial is to evaluate the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly-diagnosed myeloma after receiving 4-6 cycles of induction chemotherapy consisting of vincristin,adriamycin and dexamethasone (VAD) or thalidomide/dexamethasone between 18 to 65 years.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Single ASCT with Thalidomide maintenance
 Phase 3

Detailed Description

This is an open label clinical trial to evaluate the efficacy of single autologous hematopoietic stem cell transplantation in newly diagnosed multiple myeloma patients. All patients will receive 4-6 cycles of induction therapy which includes VAD chemotherapy (vincristin, adriamycin and dexamethasone) or thalidomide/dexamethasone. After peripheral hematopoietic stem cell mobilization and apheresis, patients will receive a standard conditioning with melphalan 200mg/m2 followed by thalidomide maintenance therapy at 100-200mg orally daily starting from D+60 till disease progression or untolerable toxicity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
Study Start Date :
May 1, 2009
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single ASCT with Thalidomide maintenance

Single ASCT followed by Thalidomide maintenance: patients recieved 4-6 cycles of standard VAD chemotherapy or Thalidomide/dexamethasone as induction therapy CTX+G-SCF mobilization to collecetd PBSC Patiens recieved Mel 200 as conditioning followed by Thalidomide 100mg maintenance

Procedure: Single ASCT with Thalidomide maintenance
Single ASCT with Thalidomide maintenance: Single Autologous Stem Cell Transplantation: conditioning with Melphalan 200mg/m2 (iv) Thalidomide maintenance: starting from D60 after transplantation at 100-200mg daily (Oral)
Other Names:
  • multiple myeloma
  • melphalan
  • thalidomie

    		•

    Outcome Measures

    Primary Outcome Measures

    1. response rate: CR/nCR/VGPR [6 months after auto-PBSCT]

    Secondary Outcome Measures

    1. overall survival [3 years]

    2. progression free survival [3 years]

    3. toxicity [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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: Jiong HU, M.D., Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT00892346
    Other Study ID Numbers:
    • MHOPES-myeloma09
    First Posted:
    May 4, 2009
    Last Update Posted:
    May 10, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
    autologous hematopoietic stem cell transplantation
    maintenance
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Thalidomide
    Melphalan

    Study Results

    No Results Posted as of May 10, 2016