In Phase III clinical trials, the treatment decreased the risk that the cancer would progress; this positive early result prompted investigators to consider a new standard of care
Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid-, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.
The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.
"These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients," said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study's co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. "We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won't come back and worsen."
These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.
Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell normally responsible for producing antibodies. In patients impacted by multiple myeloma, collections of abnormal plasma cells accumulate in the bone marrow, interfering with the production of normal blood cells. The study focused on patients who received an autologous hematopoietic cell transplant (AHCT). AHCT procedures use patients' own blood stem cells.
While lenalidomide increased a patient's ability to stave off progression of the disease, questions remain regarding future approaches recognizing that quality of life measurements were not incorporated within these studies, that long-term safety issues remain unclear as there was a small but discernable risk of second cancers observed in the treated patients. In addition to the need for that cost-benefit analysis, a comparison remains to be performed with other emerging myeloma maintenance therapies.
This Phase III study of lenalidomide was conducted at 47 medical centers and involved 568 patients. It was sponsored by the National Cancer Institute (NCI). Revlimid's manufacturer, Celgene Corp., provided the NCI with lenalidomide for this research.