The Alliance for Clinical Trials in Oncology, a national clinical trials network supported by the National Cancer Institute (NCI), is sponsoring a clinical trial for patients with solitary plasmacytoma of bone (SPB). SPB is a rare (less than 450 cases annually in the US) occurrence of myeloma in a single bone without evidence of myeloma elsewhere in the body (absence of monoclonal plasma cells in a random sample of bone marrow and no evidence of anemia, hypercalcemia, or renal involvement--that is, no CRAB criteria).
Approximately 30% of patients with SPB will develop active systemic myeloma. The current standard of care for SPB is radiation therapy followed by regularly scheduled follow-up appointments to check for signs of more widespread disease. A deeper understanding of disease biology in recent years has led to treatment studies for patients with high-risk smoldering multiple myeloma (SMM), early-stage myeloma or disease that presents no signs or symptoms, and now for SPB as well.
The new SPB clinical trial is titled "Ixazomib Citrate [Ninlaro®], Lenalidomide [Revlimid®], Dexamethasone, and Zoledronic Acid [Zometa®] or Zoledronic Acid Alone After Radiation Therapy in Treating Patients with Solitary Plasmacytoma of Bone." For more details about this study, please visit clinicaltrials.gov and search for this trial by its identifier, NCT02516423. This is a phase III clinical trial in which patients will be randomized to receive either a triplet therapy plus Zometa, or Zometa alone, within three months after they have been treated with radiation therapy, the current standard of care. For further information or to register for this clinical trial, please contact principal investigator Dr. Anuj Mahindra at [email protected].