UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients

Inclusion Criteria:

• Patients must have symptomatic multiple myeloma requiring treatment
• Patients must have been approved for single or tandem autologous transplant
• Patients must be > or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine > 3 mg/dl or a creatinine clearance < 30 ml/minute
• Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted,
• Patients must have an ECHO or MUGA performed within 60 days prior to registration, LVEF > 40%.
• Bilirubin, SGOT, SGPT must be less than 1.5 times the upper limit of normal
• Patients must have evaluable myeloma marker for response such as: *Serum M protein >1g/dl or urine M protein >1g/24 hours and/or; *Bone marrow plasmacytosis with >20% plasma cells and/or; *Extramedullary plasmacytosis; *MRI/PET scan has focal lesions due to myeloma.
• Patients must be able to receive full doses of DT-PACE, in the opinion of the treating investigator, with the exception of cisplatin.
• Patients must have a performance status of 0-2 based on SWOG criteria unless the patient's status is due to active myeloma
• All patients must be informed of the investigational nature of the study and have signed an IRB-approved informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

• Serum transaminases > 1.5 x ULN and direct bilirubin > 1.5 mg/dl
• HIV positive or active Hepatitis B or Hepatitis C infection; (if serology is positive a quantitative PCR will be done).
• Patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. Patients must not currently be receiving therapy for the prior malignancy.
• Pregnant or nursing women. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.