UARK 2003-25: A Phase I/II Open Label Study of IV Busulfan (Busulfex®) in Multiple Myeloma Patients Older Than 65 Years of Age or With Renal Insufficiency

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.