AMD3100-3102 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 (240mcg/kg) plus G-CSF (10mcg/kg) Versus G-CSF (10mcg/kg) Plus Placebo to Mobilize and Collect >6 x 106 CD34+ Cells/Kg in Multiple Myeloma Patients for Autologous Transplantation.

Principal Investigator: Peter A. McSweeney, MD

Protocol Number: RMBMT-142

Major Objectives

Patient Selection

Inclusion Criteria:

1. Age 18 to 75 years
2. Diagnosis of MM
3. Eligible for autologous transplantation
4. In first or second CR or PR
   • ≥ 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade are not considered prior chemotherapy for the purpose of this study)
5. ECOG performance status of 0 or 1
6. Recovered from all acute toxic effects of prior chemotherapy
7. WBC count > 3.0 x 10⁹/l
8. Absolute PMN count > 1.5 x 10⁹/l
9. PLT count > 100 x 10⁹/l
10. Serum creatinine ≤ 2.2 mg/dl
11. SGOT, SGPT, total bilirubin < 2 x upper limit of normal (ULN)
12. Cardiac and pulmonary status sufficient to undergo apheresis and transplantation.
13. Negative for HIV
14. Signed informed consent
15. Patients of childbearing potential agree to use an approved form of contraception.

Exclusion Criteria:

1. A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications.
2. Prior autologous or allogeneic transplant.
3. Received bone-seeking radionuclides (e.g. holmium)
4. Received more than 2 cycles of alkylating agent combinations
5. < 6 weeks off BCNU prior to first dose of G-CSF
6. Received GM-CSF or Neulasta within 3 weeks prior to first dose of G-CSF for mobilization
7. Received G-CSF within 14 days prior to the first does of G-CSF for mobilization
8. Active CNS involvement
9. Failed previous stem cell collection or collection attempts
10. A residual acute medical condition resulting from prior chemotherapy.
11. Active brain metastases or myelomatous meningitis.
12. Received thalidomide, dexamethasone, and or Velcade within 7 days prior to the first dose of G-CSF.
13. Active infection requiring antibiotics treatment
14. Fever (temperature > 38 degrees C/ 100.4 degrees F)
15. Radiation therapy to ≥ 50% of the pelvis
16. Post-transplant chemotherapy and/or radiation therapy below the diaphragm is anticipated.
17. Positive pregnancy test in female patients
18. Lactating females
19. History of ventricular arrhythmias, including ECG-documented PVCs, during the last 3 years.
20. Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase.
21. Patients whose apheresis product will be further selected and purified.