Study on Lenalidomide and CC-486 with Radiation Therapy for Patients with Plasmacytoma

Inclusion Criteria

Cohort 1: Must meet all the following 3 criteria:

• Newly diagnosed or returning solitary plasmacytoma or lytic lesion confirmed by lab tests. Minimal bone marrow involvement is allowed.
• Secretory M protein level less than 3 g/dL.

Cohort 2: Must meet all the following criteria:

• Relapsed multiple myeloma with plasmacytomas or lytic lesions suitable for radiation therapy.
• Disease has returned or progressed, shown by specific lab measurements or bone marrow involvement.
• Any number of previous treatments is allowed, including past radiation therapy and allogeneic transplants.

All Cohorts:

• Age 18 years or older.
• Surgery to remove or stabilize plasmacytoma is allowed if needed.
• Good overall health with a performance status of 0-1.
• Expected to live more than 3 months.
• Able to provide written consent.
• Kidney function with creatinine clearance of at least 30 ml/min.
• Liver function with bilirubin levels within 1.5 times the normal range, unless due to specific conditions.
• AST and ALT levels within 2.5 times the normal range.
• Women of childbearing age must avoid pregnancy and agree to regular pregnancy tests and use effective birth control during and after the study.
• Agree not to breastfeed during the study and for 90 days after the last dose.
• Men must avoid fathering a child during treatment and for 3 months after.
• Willing to join the Revlimid REMS program and follow its requirements.
• Able to take daily aspirin or other blood thinners if needed.
• Able to swallow pills.
• Blood counts must meet specific levels: Hemoglobin at least 9 g/dL, platelets at least 50,000, and ANC at least 1.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Uncontrolled infections despite treatment.
• History of certain bowel diseases or surgeries that affect drug absorption.
• Abnormal blood clotting without a known cause.
• Serious heart disease in the past 6 months.
• Allergies to azacitidine, mannitol, thalidomide, or lenalidomide.
• History of specific skin reactions to thalidomide or similar drugs.
• Active infections with HIV, hepatitis B, or hepatitis C, unless controlled.
• Receiving other systemic chemotherapy besides CC-486 and lenalidomide.
• Currently on tacrolimus therapy.