Randomized Trial of Autologous Transplantation With Filgrastim Versus Stem Cell Factor/Filgrastim-Primed CD34-Enriched Peripheral Blood Cells for Multiple Myeloma

Inclusion Criteria

INCLUSION CRITERIA

Age 70 or younger at time of pretransplant evaluation.

An established diagnosis of multiple myeloma.

ECOG performance status of 0 or 1 and a life-expectancy of greater than 6 months.

Marrow cellularity greater than 20 percent, with less than or equal to 30 percent plasma
cells within one month of study entry.

Platelet count greater than 100,000/ul, ANC greater than 1200/ul.

Demonstration of a partial or complete response to initial or salvage therapy (a minimum
of a 50 percent reduction in the detectable serum paraprotein or at least a 90 percent
reduction in the detectable urine monoclonal light chains, stable for at least four weeks
prior to entry into study). A cumulative total of less than or equal to 6 cycles of
regimens containing alkylating agents.

Bilirubin less than 2.0, transaminases less than 2x upper limit of normal, serum
creatinine less than 3.0.

Ability and willingness to give informed consent.

EXCLUSION CRITERIA

Prior bone marrow or PBSC transplant.

HIV positivity.

Extensive marrow fibrosis, non-aspirable marrow, myelodysplastic changes or greater than
30 percent marrow plasma cells.

Prior treatment with greater than 6 cycles of chemotherapy regimens containing alkylating
agents such as melphalan, cyclophosphamide or BCNU.

History of another malignancy within 5 years of protocol entry, with the exception of
localized carcinomas cured by surgical resection such as basal cell carcinoma, stage I
breast or bladder cancer, or in situ carcinoma of the cervix.

Significant nonmalignant disease including uncontrolled hypertension, unstable angina,
congestive heart failure, poorly controlled diabetes, coronary angioplasty within 6
months, myocardial infarction within 6 months, uncontrolled arrhythmias, or any other
medical condition felt by the principal investigator to unduly increase the risk of
autologous transplantation.

Significant allergy history: these criteria will be assessed via the Allergy History CRF
Screening Form.

Patients with any of the following concurrent conditions are not eligible:

No history of positive allergy tests to insect venoms (either skin or RAST).

No history of seasonal or recurrent asthma within the preceding 10 years.

No asthmatic symptoms (e.g. wheezing) related to a current respiratory tract infection.

No anaphylactic/anaphylactoid-type event manifested by disseminated urticaria, laryngeal
edema, and/or bronchospasm (or for example: food, insect bites, etc.) Patients with drug
allergies, manifest solely by rash, and/or urticaria are not excluded.

No history of angioedema or recurrent urticaria (an isolated episode of urticaria is not a
contraindication).

No active infection (including those with current symptoms of bronchoconstriction), or
fever greater than or equal to 38.2 degrees Celsius.

No known allergy to E. coli-derived products.

No concurrent use of beta adrenergic blocking agents.

No concurrent use of other investigative agents.

No pregnancy or breast-feeding. Men and women of child-bearing potential, admitted to the
trial are to be advised to take adequate measures to prevent conception.

Patients maintained on interferon, chemotherapy or hematopoietic growth factors must have
these treatments discontinued for at least four weeks prior to entry into this study.