Filgrastim Compared With Sargramostim Plus Chemotherapy, Peripheral Stem Cell Transplantation, and Interferon Alfa in Treating Patients With Multiple Myeloma

• Status: Terminated
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim and sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Interferon alfa may interfere with the growth of cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma.

PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim with that of sargramostim plus chemotherapy, peripheral stem cell transplantation, and interferon alfa in treating patients who have multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Carmustine; Cyclophosphamide; Dexamethasone; Etoposide; Interferon-alpha; Interferons; Lenograstim; Mitoxantrone; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed multiple myeloma

• Complete or partial remission after initial therapy OR

• Complete or partial response to therapy after disease progression following initial therapy

• No plasma cell leukemia (greater than 10% circulating plasma cells)

• No advanced myeloma refractory and unresponsive to at least 2 salvage chemotherapy regimens

PATIENT CHARACTERISTICS:

Age:

• 70 and under

Performance status:

• Age 65-70 years:

• Karnofsky 80-100%

• Under 65 years:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 8 g/dL (untransfused)

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3 (untransfused)

Hepatic:

• Bilirubin less than 2.0 mg/dL

• ALT less than 3 times upper limit of normal

Renal:

• Age 65-70 years:

• Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)

• Under 65 years:

• Creatinine less than 2 mg/dL

Cardiovascular:

• Age 65-70 years:

• LVEF at least 45%

• Under 65 years:

• No active ischemia

• LVEF greater than 45% by MUGA

Pulmonary:

• Age 65-70 years:

• If history of smoking or respiratory symptoms, spirometry and DLCO must be greater than 50% of predicted

• Under 65 years:

• FEV_1 and FVC greater than 60% predicted

• DLCO greater than 50% of predicted

Other:

• No active or uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified