Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

OBJECTIVES:

• 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.

Eligibility 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

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Mohamad Ahmed Hussein

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00040937
Information obtained from ClinicalTrials.gov on December 14, 2011

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