This study is evaluating the effectiveness of melphalan (Alkeran) alone compared to BEAM chemotherapy (carmustine, etoposide, cytarabine, and melphalan) in patients with multiple myeloma before a stem cell transplant (SCT). The main outcome to be measured will be the number of patients who have complete disappearance of all signs of cancer before the transplant. This study is being conducted in Seattle, Washington, United States.
Multiple myeloma is a type of cancer of the bone marrow that can lead to abnormal immune cells. High-dose chemotherapy followed by SCT is a key part of treatment. This type of chemotherapy is called a conditioning regimen. It is given before the transplant to get rid of any remaining cancer cells. BEAM is one of the most commonly used conditioning regimens. This regimen contains a chemotherapy drug called melphalan.
This study is evaluating the effectiveness of the BEAM regimen compared to melphalan alone before SCT for patients with multiple myeloma. The main outcome to be measured will be the number of patients who have a complete response (complete disappearance of all signs of cancer) before the transplant.
Who are they looking for?
This study is recruiting 100 patients with multiple myeloma. Patients should have received at least 2 prior cycles of chemotherapy treatments. All patients must agree to use contraception and should have adequate kidney, liver, and heart function tests. They should also be HIV-negative.
Patients who are pregnant or are breastfeeding cannot participate. Patients with uncontrolled infections or brain cancer cannot participate. Patients who have had ASCT before cannot participate. Patients with a history of seizures or a history of another cancer with a life expectancy of fewer than 3 years cannot participate.
How will it work
This study will involve two groups of patients. In the first group, patients will receive BEAM chemotherapy. In the second group, patients will receive melphalan only. Patients will be followed-up for 12 months.
Effectiveness will be measured as the complete response rate at 12 months after treatment. The number of patients alive at 12 months without the cancer growing or spreading will also be determined.