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

Primary Purpose

Multiple Myeloma

Status
Suspended
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Single ASCT with Thalidomide maintenance
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring autologous hematopoietic stem cell transplantation, maintenance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single ASCT with Thalidomide maintenance

Arm Description

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

Outcomes

Primary Outcome Measures

response rate: CR/nCR/VGPR

Secondary Outcome Measures

overall survival
progression free survival
toxicity

Full Information

First Posted
May 1, 2009
Last Updated
May 9, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00892346
Brief Title
Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
Official Title
Phase III Study of Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Suspended
Why Stopped
No avaliability of melphlan in mainland China
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
autologous hematopoietic stem cell transplantation, maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single ASCT with Thalidomide maintenance
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Single ASCT with Thalidomide maintenance
Other Intervention Name(s)
multiple myeloma, melphalan, thalidomie
Intervention Description
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)
Primary Outcome Measure Information:
Title
response rate: CR/nCR/VGPR
Time Frame
6 months after auto-PBSCT
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Title
progression free survival
Time Frame
3 years
Title
toxicity
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiong HU, M.D.
Organizational Affiliation
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18650178
Citation
Chang JE, Juckett MB, Callander NS, Kahl BS, Gangnon RE, Mitchell TL, Longo WL. Thalidomide maintenance following high-dose melphalan with autologous stem cell support in myeloma. Clin Lymphoma Myeloma. 2008 Jun;8(3):153-8. doi: 10.3816/CLM.2008.n.018.
Results Reference
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PubMed Identifier
17875806
Citation
Abdelkefi A, Ladeb S, Torjman L, Othman TB, Lakhal A, Romdhane NB, Omri HE, Elloumi M, Belaaj H, Jeddi R, Aissaoui L, Ksouri H, Hassen AB, Msadek F, Saad A, Hsairi M, Boukef K, Amouri A, Louzir H, Dellagi K, Abdeladhim AB; Tunisian Multiple Myeloma Study Group. Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial. Blood. 2008 Feb 15;111(4):1805-10. doi: 10.1182/blood-2007-07-101212. Epub 2007 Sep 17.
Results Reference
background
PubMed Identifier
16231846
Citation
Harousseau JL, Moreau P. Evolving role of stem cell transplantation in multiple myeloma. Clin Lymphoma Myeloma. 2005 Sep;6(2):89-95. doi: 10.3816/CLM.2005.n.034.
Results Reference
background
PubMed Identifier
19273705
Citation
Spencer A, Prince HM, Roberts AW, Prosser IW, Bradstock KF, Coyle L, Gill DS, Horvath N, Reynolds J, Kennedy N. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. J Clin Oncol. 2009 Apr 10;27(11):1788-93. doi: 10.1200/JCO.2008.18.8573. Epub 2009 Mar 9.
Results Reference
background
PubMed Identifier
19141779
Citation
Kumar A, Kharfan-Dabaja MA, Glasmacher A, Djulbegovic B. Tandem versus single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: a systematic review and meta-analysis. J Natl Cancer Inst. 2009 Jan 21;101(2):100-6. doi: 10.1093/jnci/djn439. Epub 2009 Jan 13.
Results Reference
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Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Front-line Treatment for Myeloma

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