Autologous Transplant for Multiple Myeloma

Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check
the subject's general health. Subjects will have the following tests and evaluations to find
out if they can participate:--Medical history and physical examination, including height and
weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest
x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone
marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum
pregnancy test performed. After eligible patients have been completely staged and exercised
consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth
factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients
will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood
tests will be performed frequently to evaluate the subject's response to treatment and
possible side effects of treatment. If necessary, platelet and red cell transfusions will be
given to maintain adequate levels and antibiotics will be given to treat or prevent
infection. Subjects may also require intravenous nutritional support and pain medications
during or after transplantation. The study coordinators will collect health information over
three years. They will collect information every week for 100 days, then at 6 months, 1 year,
2 years, and 3 years.

Inclusion Criteria:

- Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple
myeloma, requiring therapy and meeting one of the following:

- After initial therapy in either first complete or partial remission or no
objective response

- After achieving initial response and later disease progression, patient will be
eligible after subsequent therapy upon achievement of either complete or partial
response

- Is not eligible or has refused any protocols of higher priority

- 18 - 75 years of age

- Adequate organ function defined as:

- Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥
3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl
(untransfused)

- Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA
scan

- Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal

- Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity
(FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) >
50% predicted

- Performance status: Karnofsky performance of > 80%.

- Free of active uncontrolled infection at the time of study entry.

- At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and >
6 weeks from prior nitrosoureas.

- Patients must exercise informed voluntary consent and sign a consent form approved by
the University of Minnesota IRB: Human Subjects Committee.

Exclusion Criteria:

- Patients will be ineligible if they have advanced myeloma refractory and unresponsive
to salvage chemotherapy regimens.

- Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded
from study entry. In addition fertile men or women unwilling to use contraceptive
techniques during and for 12 months following treatment, particularly after
thalidomide will also be excluded from study entry.