This trial studies how well lenalidomide, CC-486 and radiation therapy work for the treatment of plasmacytoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CC-486 is an oral form of the drug azacitidine. CC-486 works by changing the proteins produced by the cancer cells which, when CC-486 is combined with other cancer drugs, may make the cancer cells more likely to die. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving lenalidomide, CC-486 and radiation therapy may boost the immune system’s ability to identify and destroy cancer cells, which could prevent plasmacytoma from developing into multiple myeloma or prevent multiple myeloma from getting worse (progressing).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04174196.
PRIMARY OBJECTIVE:
I. To provide preliminary efficacy data based on the rate of stringent complete response (sCR) by 2016 International Myeloma Working Group (IMWG) criteria on post-treatment bone marrow biopsy and aspirate specimens with no new lesions by positron emission tomography (PET).
SECONDARY OBJECTIVES:
I. To assess the safety of oral azacitidine and lenalidomide with radiation therapy in patients with plasmacytoma.
II. To estimate the progression free survival (PFS) by the 2016 IMWG criteria.
III. To estimate overall survival (OS).
EXPLORATORY OBJECTIVES:
I. To evaluate antigen expression at the tumor site pre and post radiation treatment.
II. To further characterize the antigen specific T cell response pre and post radiation therapy at the tumor site including but not limited to clonality and phenotype.
III. To assess changes in epigenetic marks in response to therapy.
IV. To assess changes in the tumor microenvironment in response to this therapy.
OUTLINE:
Patients receive oral azacitidine and lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting within 14 days of cycle 3 (or sooner if determined by primary investigator[PI] to be urgent), patients undergo radiation therapy daily 4-5 times a week for 5 weeks.
After completion of study treatment, patients are followed up every 3 months for 6 months, then every 6 months for 2 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorUrvi A Shah
