RATIONALE: Palifermin may help prevent symptoms of or lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy, chemotherapy, and an autologous stem cell transplant for hematologic cancer.

PURPOSE: This randomized phase III trial is comparing four different dosing schedules of palifermin to see how well they work in reducing or preventing mucositis in patients who are receiving radiation therapy and chemotherapy followed by an autologous stem cell transplant for hematologic cancer.

OBJECTIVES:

Primary

• Compare the efficacy of 4 different schedules of palifermin in reducing the incidence of severe (i.e., WHO grade 3 or 4) oral mucositis in patients receiving fractionated total-body irradiation and high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation for a hematologic malignancy.

Secondary

• Determine the duration of severe oral mucositis in patients treated with this drug.
• Determine the number of sequelae of severe oral mucositis, in terms of opiod and analgesic use, in patients treated with this drug.
• Determine the safety of this drug in these patients.
• Determine the severity of mouth and throat soreness, as measured by patient-reported outcome, in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to concurrent etoposide use (yes vs no) and number of days of fractionated total-body irradiation (fTBI) (3 vs 4). Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive palifermin IV and placebo IV once daily on days -11 to -9 or -10 to -8 or -9 to -7 or -8 to -6. Patients also receive palifermin IV once daily on days 0-2.
• Arm II: Patients receive palifermin IV once on day –9, -8, -7, or –6 and then once daily on days 0-2. Patients also receive placebo IV once daily on days –11 and –10 or -10 and –9 or -9 and –8 or –8 and –7.
• Arm III: Patients receive palifermin IV once on day –10, -9, -8, or –7 and then once daily on days 0-2. Patients also receive placebo IV once daily on days –11 and –9 or -10 and –8 or -9 and –7 or –8 and –6.
• Arm IV: Patients receive palifermin IV once on day –11, -10, -9, or –8 and then once daily on days 0-2. Patients also receive placebo IV once daily on days –10 and –9 or -9 and –8 or -8 and –7 or –7 and –6.
• All patients receive 1 of the following conditioning regimens:
• Regimen 1: Patients undergo fTBI on days –8 to –5. Patients also receive high-dose etoposide IV over 4 hours on day –4 and high-dose cyclophosphamide IV on day –2.
• Regimen 2: Patients undergo fTBI on days –7 to –5. Patients also receive etoposide and cyclophosphamide as in regimen 1.
• Regimen 3: Patients undergo fTBI on days –6 to –3. Patients also receive cyclophosphamide as in regimen 1.
• Regimen 4: Patients undergo fTBI on days –5 to –3. Patients also receive cyclophosphamide as in regimen 1.
• Autologous peripheral blood stem cell transplantation (PBSCT): All patients undergo autologous PBSCT on day 0. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 0 and continuing until day 21 or until blood counts recover.

After completion of study treatment, patients are followed at 4 weeks, 6 months, and then annually for up to 5 years.

PROJECTED ACCRUAL: Approximately 324 patients (81 per treatment arm) will be accrued for this study within 17 months.

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:
• Non-Hodgkin''''s lymphoma
• Hodgkin''''s lymphoma
• Acute myeloid leukemia
• Acute lymphoblastic leukemia
• Chronic myelogenous leukemia
• Chronic lymphocytic leukemia
• Multiple myeloma
• Must be eligible for fractionated total-body irradiation and high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation
• At least 1.5 x10
• autologous CD34-positive cells/kg cryopreserved
• No negatively-selected (purged) stem cell product
• No oral mucositis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and/or ALT ≤ 3 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV congestive heart failure

Pulmonary

• DLCO ≥ 50% of predicted (corrected)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception
• No history of or active pancreatitis
• No active infection
• No other malignancy except adequately treated basal cell skin cancer
• No known sensitivity to study drugs (including E. coli-derived products)
• No disorder that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior bone marrow or peripheral blood stem cell transplantation
• No concurrent interleukin-11 (Neumega® or oprelvekin)
• No concurrent sargramostim (GM-CSF)

Chemotherapy

• Concurrent intrathecal methotrexate or cytarabine allowed (for patients with CNS involvement of the tumor)

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 30 days since prior and no concurrent participation in another study of an investigational device or drug
• No prior randomization into this study
• No other concurrent investigational procedures or agents
• No concurrent prophylactic oral cryotherapy during chemotherapy administration
• No concurrent ''''magic mouthwash'''' or ''''miracle mouthwash'''' solutions containing any of the following:
• Chlorhexidine
• Hydrogen peroxide
• Diphenhydramine
• No concurrent sucralfate or povidone-iodine rinses
• No concurrent prophylactic glutamine for mucositis
• No other concurrent cytotoxic drugs