E-Newsletter - February 2017

Post RT Treatment Options on Multiple Myeloid Progression at the center of Alliance trial

Solitary Plasmacytoma of the Bone - Alliance A061402
Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy

Solitary plasmacytoma (SPB) of the bone is a localized build-up of abnormal plasma cells in the bone. The median age at diagnosis is 55 to 65 years and the median overall survival rate of approximately 10 years. The primary treatment for patients with SPB is localized radiation therapy. More than half of patients with SPB will eventually develop overt multiple myeloma.

Considering that fact that patients with SPB with measurable disease have a high risk of progression to multiple myeloma and that there are no accepted treatment options post radiation therapy, Alliance researcher aim to understand the impact of adjuvant treatment after radiation in the management of SPB. In Alliance A061402 , Alliance researchers will compare ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid with zoledronic acid alone to see how well they work when given after radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic acid may prevent bone fractures and reduce bone pain, and may also improve survival.

Standard treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more effective, and whether adding these treatments after radiation therapy is more effective than radiation therapy alone in treating patients with solitary plasmacytoma of bone.

This trial will assess the impact of the addition of ixazomib, lenalidomide, and dexamethasone to zoledronic acid on the multiple myeloma progression rate at five years. A dynamic allocation procedure will be used to allocate an equal number of patients to each of the treatment arms. This procedure will balance the number of patients that falls into each of the following categories between the two treatment arms: 1) percentage of abnormal plasma cells in the bone marrow: 5-9 percent and 2) age.

Important inclusion eligibility criteria for the study include histologic documentation of solitary bone plasmacytoma. For patients pre-registering after the completion of radiation therapy, documentation of a bone marrow aspirate and biopsy containing less than 9 percent clonal plasma cells done at most 28 days prior to start of radiation therapy. For patients pre-registering before the start of radiation therapy, radiation therapy scheduled to begin at most 28 days after a bone marrow aspirate and biopsy were performed containing less than 10 percent clonal plasma cells. For patients who pre-registered after the completion of radiation therapy (RT): no treatment for this disease following radiation therapy and registration must be completed within 90 days of completion of radiation therapy. For patients who pre-registered before the start of RT: no treatment for this disease following radiation therapy; registration must be completed within 45 days of completion radiation therapy; and there must be an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

To learn more about this study, refer to the study protocol (Alliance A061402), which can be found on the CTSU menu (ctsu.org) and includes complete information on the trial design, treatment plan and patient eligibility. The Alliance Study Chair is Anuj Mahindra, MD, Scripps Health, e-mail: mahindra.anuj@scrippshealth.org. Also see ClinicalTrial.gov Identifier: NCT02516423.

 

For other articles in the February issue of the Alliance E-News newsletter, see below.