Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 65 NCI SWOG-S0204 S0204, NCT00040937

Objectives

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• No more than 8 weeks of prior thalidomide therapy

Chemotherapy

• No prior chemotherapy for this disease

Endocrine therapy

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

Radiotherapy

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

Surgery

• Not specified

Patient Characteristics:

Age

• 18 to 65

Performance status

• Zubrod 0-2

  OR

• Zubrod 3-4 based solely on bone pain

Life expectancy

• Not specified

Hematopoietic

• No untreated, unresolved symptomatic hyperviscosity

Hepatic

• Hepatitis B negative

Renal

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

Cardiovascular

• 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

Pulmonary

• 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

Other

• 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

Expected Enrollment

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

Outcomes

Efficacy
Toxicity
Safety
Correlation of chromosome 13 abnormalities with therapeutic response
Correlation of chromosome aberrations with event-free survival and overall survival
Immune reconstitution and recovery

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.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Mohamad Hussein, MD, Protocol chair		Ph: 216-445-6830; 800-862-7798 Email: husseim@ccf.org

Registry Information
Official Title		A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)
Trial Start Date		2002-06-14
Registered in ClinicalTrials.gov		NCT00040937
Date Submitted to PDQ		2002-05-09
Information Last Verified		2005-10-04
NCI Grant/Contract Number		CA32103

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