Titolo della ricerca: DARATUMUMAB VERSUS OBSERVATION IN SUBJRCTS WITH SMOLDERING MULTIPLE MYELOMA.
Progetto di ricerca: MULTIPLE MYELOMA IS A MOSTLY INCURABLE MALIGNANT PLASMA CELL DISORDER THAT IN A MAJORITY OF PATIENTS, EVOLVES FROM PREMALIGNANT, ASYMPTOMATIC PLASMA CELL DISORDERS SUCH AS MONOCLONAL GAMMAPATHY OF UNDETERMINED SIGNIFICANCE (MGUS) OR SMOLDERING MULTIPLE MYELOMA (SMM), THAT ARE CHARACTERIZED BY MONOCLONAL PLASMA CELL PROLIFERATION IN THE BONE MARROW AND ABSENCE OF END-ORGAN DAMAGE SUCH AS RENAL FAILURE, ANEMIA, AND LYTIC BONE LESIONS. SMM ACCOUNTS FOR APPROXIMATELY 15% OF ALL MYELOMA PATIENTS AND PROGRESSES TO SYNPTOMATIC MM AT A RATE OF 10% PER YEAR FOR THE FIRST 5 YEARS, DECREASING TO 3% PER YEAR OVER THE FOLLOWING 5 YEARS. THERE ARE NO APPROVED TRATMENT FOR PATIENTS WITH SMM. OUTSIDE OF CLINICAL STUDIES, CLINICAL MANAGEMENT INVOLVES CLOSE MONITORING UNTIL THE DEVELOPMENT OF SYMPTOMATIC DISEASE. SOME EARLY STUDIES THAT INVESTIGATED TRATMENT FOR SMM WITH VARIOUS CHEMOTHERAPY REGIMENS (MELPHALAN-PREDNISONE, THALIDOMIDE) OR BISPHOSPHONATES DID NOT SHOW CONSISTENT CLINICAL BENEFIT AND THE REGIMENS WERE OFTEN POORLY TOLERATED. DATA FROM A RECENT STUDY OF LENALIDOMIDE AND DEXAMETHASONE OF PATIENTS WITH SMM SHOWED THAT LENALIDOMIDE-BASED TRATMENT WAS ASSOCIATED WITH A SIGNIFICANT DELAY IN THE PROGRESSION TO SYMPTOMATIC MYELOMA. THIS STUDY IS DESIGNED TO EVALUATE WHETHER DARATUMUMAB (A HUMAN IgG1k MONOCLONAL ANTIBODY) ADMINISTERED AT 16 MG/KG IS EFFECTIVE IN DELAYING THE TRANSITION FROM SMM TO ACTIVE MM COMPARED TO OBSERVATION.