High Dose Melphalan and Autologous Peripheral Blood Stem Cell Transplant As Rescue Therapy for Multiple Myeloma

Protocol Number: RMBMT-05

Major Objectives

Patient Selection

Inclusion Criteria:

1. Be 18 years of age or older.
2. Have multiple myeloma in one of the following categories:
   • A previous response and relapsed disease.
   • No previous response and refractory disease.
   • Stage II/III myeloma as part of initial treatment
   • Being considered for a second transplant.
3. Be practicing effective birth control.
4. Have an ECOG performance status of 0 or 1 and life expectancy of at least 6 months. Patients with a poor performance status (3, 4) when based solely on bone pain, will be eligible.
5. Have major end organs (heart, lungs, liver, and kidneys) have been assessed and deemed adequate to withstand the effects of the high dose therapy planned for this program. This assessment and determination will be made at the discretion of the transplant physician.
6. Have an adequate number of hematopoietic stem cells for transplant collection collected by mobilization and apheresis (minimum of 2.0 x 10⁶ CD 34+ cells/Kg) or marrow harvesting (minimum of 2.0 x 10⁶ CD 34+ cells/Kg) and stored by cryopreservation.
7. Have given voluntary informed consent.

Exclusion Criteria:

1. Have symptoms related to a history of cerebral vascular accident.
2. Have a history of previous malignancy, except non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for > 5 years.
3. Have uncontrolled diabetes.
4. Are HIV antibody positive.
5. Have any condition that makes them unacceptable for high-dose chemotherapy.