S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00040937
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : July 17, 2013
Last Update Posted : December 8, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma.

PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: dexamethasone Drug: melphalan Drug: prednisone Drug: thalidomide Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma.
  • Determine, preliminarily, the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients.
  • Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen.
  • Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen.
  • Evaluate immune reconstitution and recovery after first and second transplantation in these patients.

OUTLINE: This is a multicenter study.

  • Induction chemotherapy: Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Stem cell mobilization and collection: Beginning 5-7 days, but no more than 3 weeks, after completion of induction chemotherapy, patients receive cyclophosphamide IV over 45-60 minutes on day 0, filgrastim (G-CSF) subcutaneously (SC) on days 1-10, and sargramostim (GM-CSF) SC beginning on day 1 and continuing until completion of peripheral blood stem cell (PBSC) collection. Patients begin PBSC collection on day 11 or as soon as blood counts recover.
  • First transplantation: Within 3-6 weeks after cyclophosphamide administration, patients receive melphalan IV over 20 minutes on day -1. Patients undergo PBSC infusion on day 0. Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover.
  • Second transplantation: Between 2-4 months after first transplantation, patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above.
  • Maintenance therapy: Beginning 70-90 days post-transplantation, patients receive oral prednisone every other day and oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 months for 10 years.

PROJECTED ACCRUAL: Approximately 99 patients will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)
Study Start Date : June 2002
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide

Arm Intervention/treatment
Experimental: treatment arm
thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
Biological: filgrastim
PBSC collection: 10 mcg/kg SQ days 1-10
Other Name: G-CSF

Biological: sargramostim

PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis

1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery

Other Name: GM-CSF

Drug: cyclophosphamide
PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
Other Name: cytoxan

Drug: dexamethasone
40 mg/d PO days 1-4, 9-12, 17-20
Other Name: decadron

Drug: melphalan
  1. st trans: 140 mg/m2 IV over 20 mins day -1
  2. nd trans: 200mg/m2 IV over 20 mins day -1

Drug: prednisone
maint: 50 mg/d PO every other day until progression
Other Name: steroid

Drug: thalidomide
ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression
Other Name: thalomid

Procedure: peripheral blood stem cell transplantation
2-4 x 10^6/kg IV day 0
Other Name: stem cell transplant

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 4-7 years ]

Secondary Outcome Measures :
  1. Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen. [ Time Frame: Induction ]
    To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed multiple myeloma requiring treatment

    • Smoldering myeloma with evidence of progressive disease requiring chemotherapy

      • More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development
    • Non-secretory patients with at least 30% bone marrow plasmacytosis
  • No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions



  • 18 to 65

Performance status

  • Zubrod 0-2 OR
  • Zubrod 3-4 based solely on bone pain

Life expectancy

  • Not specified


  • No untreated, unresolved symptomatic hyperviscosity


  • Hepatitis B negative


  • Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after hydration and/or correction of hypercalcemia)


  • No history of chronic cerebrovascular accident
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No congestive heart failure that is difficult to control
  • No uncontrollable hypertension
  • No cardiac arrhythmia that is difficult to control


  • No history of chronic obstructive or chronic restrictive pulmonary disease
  • No untreated, unresolved pneumonia
  • Pulmonary function tests (PFTs) at least 50% of predicted
  • DLCO at least 50% of predicted
  • Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to bone pain or fracture


  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No untreated, unresolved pathologic fractures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use at least 2 highly effective methods of contraception for 4 weeks before, during, and for at least 4 weeks after study participation


Biologic therapy

  • No more than 8 weeks of prior thalidomide therapy


  • No prior chemotherapy for this disease

Endocrine therapy

  • Prior steroid therapy allowed provided treatment duration was no more than 2 weeks


  • No prior radiotherapy to more than 50% of the pelvis


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00040937

  Show 141 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Mohamad A. Hussein, MD The Cleveland Clinic

Publications of Results:
Hussein MA, Jakubowiak AJ, Bolejack V, et al.: S0204: melphalan (MEL)-based tandem autotransplants (TAT) for multiple myeloma (MM) with thalidomide/dexamethasone (TD) induction and thalidomide/prednisone (TP) maintenance: a phase II trial of the Southwest Oncology Group. [Abstract] Blood 108 (11): A-3088, 2006.

Responsible Party: Southwest Oncology Group Identifier: NCT00040937     History of Changes
Other Study ID Numbers: S0204
S0204 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: July 17, 2013
Last Update Posted: December 8, 2016
Last Verified: October 2016

Keywords provided by Southwest Oncology Group:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents