Multiple Myeloma Clinical Trial
Official title:
Phase I/II Study of Oral Lenalidomide and High Dose Melphalan Supported by Autologous Peripheral Blood Stem Cell Infusion for Patients With Multiple Myeloma
This is a research study for newly diagnosed multiple myeloma or multiple myeloma has
returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells
called plasma cells. Plasma cells make proteins that help fight infections. Current therapy
for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells)
stem cell transplantation.
There will be two parts (or phases) to this study:
The purpose of the first part is to find the highest dose of a drug called lenalidomide
(Revlimid®) that can be given in combination with high dose melphalan without causing severe
adverse events.
The purpose of the second part is to find out the effects of this treatment (good and bad) on
multiple myeloma patients.
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.
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