Comparing Post-transplant Therapies for Multiple Myeloma Patients
Name of the Trial
Stem Cell Transplant with Lenalidomide Maintenance in Patients with Multiple Myeloma (BMT-CTN-0702). See the protocol summary.
Dr. Amrita Y. Krishnan, Dr. George Somlo, and Dr. Edward Allen Stadtmauer, Blood and Marrow Transplant Clinical Trials Network
Why This Trial Is Important
Multiple myeloma is a cancer in which the body produces too many plasma cells, which are white blood cells that produce proteins called immunoglobulins. The plasma cells in multiple myeloma are abnormal and secrete excess amounts of immunoglobulin protein, which can be deposited in the kidneys and lead to kidney failure. In addition, the plasma cells can stimulate bone cells known as osteoclasts, which break down bone tissue, leading to increased bone fractures. Treatment with high-dose chemotherapy followed by transplantation of the patient's own blood-forming stem cells (known as autologous stem cell transplantation) is a cornerstone of multiple myeloma therapy for eligible patients. Although this treatment often produces remission, it is not a cure, and most patients eventually relapse.
A number of advances in multiple myeloma treatment are helping to extend the lives of patients with this disease. Several research groups have demonstrated that a second round of chemotherapy and autologous stem cell transplantation can improve the likelihood of a near-complete response and extend progression-free survival. It has also been reported that maintenance therapy with the drugs thalidomide or lenalidomide can improve survival. And, a number of studies have suggested that combination chemotherapy that includes the drugs bortezomib, lenalidomide, and dexamethasone as either initial treatment or treatment for relapsed disease can induce high remission rates in both newly diagnosed patients and those with relapsed disease.
In this trial, patients age 70 or younger with multiple myeloma will be randomly assigned to treatment with one of three regimens after receiving high-dose melphalan chemotherapy and autologous stem cell transplantation: 1) a second round of melphalan chemotherapy and stem cell transplantation, followed by maintenance therapy with lenalidomide; 2) consolidation therapy with lenalidomide, bortezomib, and dexamethasone, followed by lenalidomide maintenance therapy; or 3) lenalidomide maintenance therapy alone. All patients will receive lenalidomide maintenance therapy for 3 years or until disease progression or unacceptable toxicity occurs. Doctors will monitor the patients for progression-free survival, response rates, event-free survival, overall survival, and side effects of treatment.
"The current therapies we have for multiple myeloma are great at producing remission, but they are not curative, so the challenge is maintaining those remissions," said Dr. Krishnan. "This trial very logically builds upon the last 10 or 15 years of experience both in transplants for myeloma as well as the use of these new drugs bortezomib and lenalidomide in improving outcomes of the disease."
"Transplants are still relevant in multiple myeloma treatment," Dr. Somlo said. "The question here is what is the best way to sequence therapy involving a transplant—is it better to do one or two transplants in conjunction with lenalidomide maintenance therapy, and can novel therapies take the place of a [second] transplant?"
"We feel that all three of these strategies are good strategies for multiple myeloma treatment, but our hope is that one will rise above the others," Dr. Krishnan added.