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

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

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892346

Enrollment

Registered

2009-05-04

Start date

2009-05-31

Completion date

2017-12-31

Last updated

2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

autologous hematopoietic stem cell transplantation, maintenance

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.

Interventions

PROCEDURESingle ASCT with Thalidomide maintenance

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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
response rate: CR/nCR/VGPR	6 months after auto-PBSCT

Secondary

Measure	Time frame
overall survival	3 years
progression free survival	3 years
toxicity	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026