Study shows benefit of new maintenance therapy for multiple myeloma

Multiple myeloma is a form of cancer where the plasma cells in the bone marrow grow out of control, causing damage to bones as well as predisposing patients to anemia, infection and kidney failure. A medical procedure called autologous hematopoietic stem cell transplantation, commonly known as a stem cell transplant, is frequently an important treatment option for many patients.

Unfortunately, multiple myeloma continues to progress even after a transplant. A study published today in the New England Journal of Medicine offers promising news about a new long-term therapy, lenalidomide, that can be used after transplantation to slow down the progression of the disease.

Thomas Shea, MD, Director of the Bone Marrow and Stem Cell Transplant Program and Associate Director for Outreach Programs at UNC Lineberger and Don Gabriel, MD, Professor of Medicine in the division of hematology/oncology, were both co-authors on the clinical trial, which measured the effect of maintenance lenalidomide therapy on disease-free progression after transplant.

The phase 3 study demonstrated that maintenance therapy with lenalidomide, an oral drug that can be taken for many months or even years, is associated with significant improvement in outcomes for patients with newly diagnosed myeloma who have undergone a transplant. The probability of surviving free of disease progression (the primary end point) for three years was 59 percent in the lenalidomide group, as compared with 35 percent in the placebo group.

"The results of this trial will change our treatment of multiple myeloma patients," said Dr. Shea.

"While lenalidomide has some risks, including an increase in people developing second cancers, it generally appears to be well-tolerated when given long-term and was associated with a delay in time to progression of the myeloma as well as an improvement in overall survival" he added.

Shea noted that another study in France showed similar improvement in delaying progression of the myeloma following transplant, but did not improve how long patients lived after their transplant compared to those receiving a placebo. Additional studies need to be conducted and longer follow-up of the current studies will need to be undertaken to confirm whether there is a real survival benefit of lenalidomide therapy for these patients.
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The US trial was supported by the National Cancer Institute. Celgene provided the lenalidomide and placebo used in this trial.

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Ellen de Graffenreid
edegraff@med.unc.edu
919-962-3405
University of North Carolina School of Medicine