Phase I/II Study of Oral Lenalidomide and High Dose Melphalan Supported by Autologous Peripheral Blood Stem Cell Infusion for Patients With Multiple Myeloma
Lenalidomide is a drug that interferes with the development of tiny blood vessels that help
tumors grow. Lenalidomide in combination with dexamethasone is approved by the Food and
Drug Administration (FDA) for the treatment of relapsed multiple myeloma. It is also
approved for the treatment of specific types of myelodysplastic syndrome (MDS), another
blood cancer. Other research studies using lenalidomide in combination with other drugs in
subjects with newly diagnosed multiple myeloma also show good response rate.
High dose melphalan is approved by the FDA and is commonly used in multiple myeloma
treatment prior to stem cell transplantation. This combination of lenalidomide, high-dose
melphalan and stem cell transplantation has not been studied in newly diagnosed and relapsed
multiple myeloma, so it is considered experimental. In research studies, "experimental"
refers to a drug or procedure that has undergone basic laboratory testing and received
approval from the US Food and Drug Administration (FDA) to be tested in human subjects. A
drug or procedure may be approved by the FDA for use in one disease or condition, but be
considered experimental in other diseases or conditions.
In this study, lenalidomide will be given together with melphalan (chemotherapy) with the
hope that more disease will be killed before the stem cell transplant. Three months after
the transplant, patients will take lenalidomide again with the hope that this will help
prolong the time when the disease is in remission.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the recommended phase II dosing and toxicity profile of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma
Attaya Suvannasankha, MD
Indiana University School of Medicine
United States: Institutional Review Board
|IU Simon Cancer Center||Indianapolis, Indiana 46202|