Safety and Eficacy of Low Dose- Bortezomib Plus Melphalan/Prednisone (velcadito protocol) in Elderly Patintes Not Eligible to Transplant in Newly Dignosed Multiple Myeloma. Restrospective Study of 26 Patients

Introduction: Protocols based on bortezomib have become the standard therapy in the elderly and not eligible for transplantation. The VISTA study showed OR 71%, CR 30%, regardless of adverse factors such as age, renal failure or cytogenetic changes, but the patient had a high rate neuropathy (44%). The Spanish group and the Italian group modified the dose of bortezomib achieving rates of CR 22% and 20%, reducing neurotoxicity 8% and 5% respectively.

We present the experience of 26 newly diagnosed patients treated with low-dose bortezomib associdados the melphalan / prednisone (Velcadito protocol).

Objective: The aim of this study is to assess the effectiveness and safety of low-dose bortezomib in elderly patients not eligible to transplant. We evaluated according to the criteria IMWG.

Results: We evaluated 26 patients treated at the Hospital Universitario de Alava (Spain) and Hospital Israelita Albert Einstein (Brazil) among 2004 to 2016. The patients received 1 cycle with bortezomib 1.3mg/m2 (days 1,4,8,11) associated with melphalan 9 mg/m2 (1- 4 days) and prednisone 60mg/m2 (1- 4 days) 28 days cycle. From the 2nd cycle the patient received low doses of bortezomib (1 mg / m2, days 1 and 4) no change in other drugs and treatment regimen.

The mean age was 78 years. 50% men/ 50% women. 2 patients had poor cytogenetics Pronóstico, 1 intermediate and 23 standard. According to the IMWG: ISS1 = 7 (26%) ISS 2 = 10 (38.5%), ISS3 = 6 (23%). 38,4% (n=10) of patientes had neuropathy but only 11,5%(n=3) grade 3-4. 61,5% (n=16) presented as neutropenia toxicity, 19,2% (n=5) with grade 3 (neutrophils <1000). 15,3% (n=4) had thrombocytopenia with grade greater than 3. Response rate was 100%, and if we consider at least PR was 92% (CR 38.5% VGPR 31%). The global survival had median of 80 months (95% confidence interval 57,8 - 102,1%) and the survival free of progression had median of 37 months (95% confidence interval 15 - 58,9%) with follow-up of 91 months.

Conclusion: The use of velcadito protocol is safe, very effective and seems to be a good option for elderly patients with newly diagnose MM. A pharmacoeconomic analysis is recommended to assess the impact of the cost of treatment. Being a prospective clinical trial where an analysis of this impact of all patients treated with subcutaneous bortezomib beyond the characteristics of this study.