D.T. PACE Versus High Dose Melphalan and Autologous Transplant in Patients With Previously Treated Multiple Myeloma

Inclusion Criteria:

• Patients must have previously treated (> 1 cycle prior therapy), active multiplemyeloma requiring treatment. Patients that have received >450 mg/m2 of priorAdriamycin therapy are eligible, however, Adriamycin will be deleted from the DT PACEregimen in these patients.

• Patients must have measurable disease defined as one of the following: serummonoclonal protein >/= 1.0 mg/dl, OR urine monoclonal protein >/= 1.0 grams/24 hour,OR >/= 20% bone marrow plasmacytosis.

• All necessary baseline studies for determining eligibility must be obtained within 35days prior to registration.

• Patients must have a performance status of 0-2 based on SWOG criteria.Patients with apoor performance status (3-4), based solely on bone pain, will be eligible.

• Patients must have a platelet count > or = 100,000/microliters. Patients with plateletcount < 100,000/microliters may be enrolled if it is felt to be due to extensivemarrow plasmacytosis. The study coordinator must be consulted and dose modificationsmay apply.

• All patients must be informed of the investigational nature of this study and mustsign and give written informed consent in accordance with institutional and federalguidelines.

Exclusion Criteria:

• Patients must not have received a prior autotransplant or allograft.

• Patients must not have significant co-morbid medical conditions or uncontrolled lifethreatening infection.

• Patients with recent (< o= 6 months) myocardial infarction, unstable angina, difficultto control congestive heart failure, uncontrolled hypertension, or difficult tocontrol cardiac arrythmias are ineligible. Ejection fraction by ECHO or MUGA should bewithin the institutional normal range and must be performed within 42 days prior toregistration.

• Patients must not have a history of chronic obstructive or chronic restrictivepulmonary disease.Patients must have adequate pulmonary function studies > or = 50% ofpredicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > or = 50% of predicted. Patients unable to complete pulmonary function tests due to myelomarelated pain or fracture must have a high resolution CT scan of the chest and mustalso have acceptable arterial blood gases defined as P02 greater than 70.

• No prior malignancy is allowed except for adequately treated basal cell or squamouscell skin cancer, in situ cervical cancer, or other cancer for which the patient hasbeen disease free for at least three years. Prior malignancy is acceptable providedthere has been no evidence of disease within the three-year interval and there must beno prior treatment with cytotoxic drugs that could potentially be assigned on thistreatment protocol.

• Pregnant or nursing women may not participate. Women of childbearing potential musthave a negative pregnancy documented within one week of registration. Women/men ofreproductive potential may not participate unless they have agreed to use an effectivecontraceptive method.