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

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

NCT ID: NCT00892346

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Thalidomide
Melphalan

Conditions: Keywords:
autologous hematopoietic stem cell transplantation
maintenance

Study type: Interventional

Study phase: Phase 3

Overall status: Suspended

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Single ASCT with Thalidomide maintenance
Description: 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)
Arm group label: Single ASCT with Thalidomide maintenance

Other name: multiple myeloma

Other name: melphalan

Other name: thalidomie

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Address:
City: Shanghai
Zip: 200025
Country: China

Start date: May 2009

Completion date: December 2017

Lead sponsor:
Agency: Shanghai Jiao Tong University School of Medicine
Agency class: Other

Source: Shanghai Jiao Tong University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00892346