Multiple myeloma: AIFA gives the green light to two three-drug combinations

It sometimes starts with bone pain or severe backache. Some patients develop unexplained fractures, kidney problems or infections. In terms of age, those over 65 are particularly at risk. We are talking about multiple myeloma, a blood cancer that affects plasma cells: white blood cells in the bone marrow that help to fight infections. When plasma cells escape the body’s control and multiply too quickly, they can lead to myeloma; as they accumulate, they can cause damage to organs and lesions.

Multiple myeloma is the second most common haematological cancer after non-Hodgkin’s lymphoma and accounts for 1–2 per cent of all cancers and 10–15 per cent of haematological cancers. The disease mainly affects older people, with an average age at diagnosis of around 70 years (only 2 per cent of patients are under 40); furthermore, it is slightly more common in men. In Italy, there are an estimated 6,590 new cases of multiple myeloma each year: this accounts for 1.5 per cent of all cancers diagnosed in women and 1.6 per cent of all cancers diagnosed in men.

In recent years, the availability of new, more effective and safer drugs has led to a significant improvement in patients’ life expectancy. Thanks to innovative treatments, the survival rate has virtually doubled since the early 2000s. Currently, various immunotherapy strategies are being investigated for the treatment of haematological cancers: monoclonal antibodies were the first form of immunotherapy used in clinical practice for the treatment of multiple myeloma. Subsequently, research has made significant progress, leading to the development of new treatments, including antibody-drug conjugates (ADCs), bispecific antibodies and CAR-T cells.

Among ADCs, two weeks ago, AIFA approved and made belantamab mafodotin – developed by GSK – available in Italia as the treatment of choice for multiple myeloma at first relapse. For less than a year now, thanks to access programmes, around 400 patients across almost all haematology centres have been receiving the drug, which forms the cornerstone of two three-drug regimens: one comprising bortezomib and dexamethasone, the other pomalidomide and dexamethasone. These combinations were tested in two clinical trials, Dreamm 7 and Dreamm 8 respectively, the results of which first led to European approval last year and now to approval in Italia.

Real-world data have confirmed the efficacy of the treatment. A further point, highlighted by Elena Zamagni, a lecturer in Haematology at the University of Bologna and senior consultant at the IRCCS Sant’Orsola Malpighi, is how life on the ward goes beyond the rigidity of protocols: “Given that belantamab is the cornerstone of the triple-agent regimens, the combinations are selected and tailored according to the patient’s individual characteristics, their acquired resistance to the other agents, and their previous exposure to other drugs. Belantamab mafodotin is also an easy-to-manage drug; it can be administered on an outpatient basis – the infusion lasts 30 minutes every 8–12 weeks, precisely because of its versatility and dose flexibility – without the need for premedication or hospitalisation, making the treatment easily accessible even in less well-equipped haematology wards”.