Palifermin

This phase I/II trial studies the side effects and best dose of melphalan and total marrow irradiation and how well they work with autologous stem cell transplantation in treating patients with high-risk multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total marrow irradiation is a type of radiation therapy and a form of total body irradiation that may deliver focused radiation to the major marrow sites where cancer cells reside. Giving chemotherapy and total-body irradiation before a peripheral autologous blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Background:
- In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given to a recipient. Sometimes the recipient s immune system destroys the donor s cells. Or donor immune cells attack the recipient s tissues, called graft-versus-host disease (GVHD). This is less likely when the recipient and donor have similar human leukocyte antigens (HLA). Researchers want to see if the drug palifermin improves the results of allogeneic SCT from HLA-matched unrelated donors.
Objective:
- To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and improve immune function after transplant.
Eligibility:
- Adults 18 years of age or older with blood or bone marrow cancer with no HLA-matched sibling, but with a possible HLA-matched donor.
Design:
Participants will be screened with medical history, physical exam, and blood and urine tests. They will have scans and heart and lung exams.
Before transplant, participants will:
Have many tests and exams. These include blood tests throughout the study and bone marrow biopsy.
Get a central line catheter if they do not have one.
Have 1-3 rounds of chemotherapy.
Take more tests to make sure they can have the transplant, including medical history, physical exam, and CT scan.
Get palifermin by IV and more chemotherapy. They will get other drugs, some they will take for 6 months.
Participants will get the SCT.
After transplant, participants will:
Be hospitalized at least 3-4 weeks.
Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and biopsies.
Stay near D.C. for 3 months.
Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.