Know Cancer

forgot password

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

Phase 3
18 Years
65 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate: CR/nCR/VGPR

Outcome Time Frame:

6 months after auto-PBSCT

Safety Issue:


Principal Investigator

Jiong HU, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine


China: Ethics Committee

Study ID:




Start Date:

May 2009

Completion Date:

May 2013

Related Keywords:

  • Multiple Myeloma
  • autologous hematopoietic stem cell transplantation
  • maintenance
  • Multiple Myeloma
  • Neoplasms, Plasma Cell