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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single ASCT with Thalidomide maintenance

Single ASCT followed by Thalidomide maintenance:

1. patients recieved 4-6 cycles of standard VAD chemotherapy or Thalidomide/dexamethasone as induction therapy
2. CTX+G-SCF mobilization to collecetd PBSC
3. Patiens recieved Mel 200 as conditioning followed by Thalidomide 100mg maintenance

Group Type EXPERIMENTAL

Single ASCT with Thalidomide maintenance

Intervention Type 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)

Interventions

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Single 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)

Intervention Type PROCEDURE

Other Intervention Names

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multiple myeloma melphalan thalidomie

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No