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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00892346
First received: May 1, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Multiple Myeloma
Procedure: Single ASCT with Thalidomide maintenance
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • response rate: CR/nCR/VGPR [ Time Frame: 6 months after auto-PBSCT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study arm
Single Autologous Stem Cell Transplantation Followed by Thalidomide maintenance after 4-6 cycles of standard VAD chemotherapy or Thalidomide/dexamethasone induction
Procedure: Single ASCT with Thalidomide maintenance
  1. Single Autologous Stem Cell Transplantation: conditioning with Melphalan 200mg/m2 (iv)
  2. Thalidomide maintenance: starting from D60 after transplantation at 100-200mg daily (Oral)
Other Names:
  • multiple myeloma
  • melphalan
  • thalidomie

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.

  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: NCT00892346

Contacts
Contact: Jiong HU, M.D. 0086-21-64370045 ext 601818 hujiong@medmai.com.cn
Contact: Wei Tang, M.D. 0086-21-64370045 ext 601878 weiwei_tang@yahoo.com

Locations
China
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Jiong HU, M.D.    0086-64370045 ext 601818    hujiong@medmail.com.cn   
Principal Investigator: Jiong HU, M.D.         
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
  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     History of Changes
Other Study ID Numbers: MHOPES-myeloma09
Study First Received: May 1, 2009
Last Updated: March 18, 2014
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
autologous hematopoietic stem cell transplantation
maintenance

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
Melphalan
Thalidomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014