S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma | NCT00040937 | Trialant

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma | NCT00040937 | Trialant

Official Title: A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)
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.
Detailed Description: 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.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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