Multiple Myeloma, Real-Time Data in the Last Five Years in Albania, 2019-2023
Authors: Lapaj Irma , Cili Alma , Caja Tatjana , Pulluqi Polikron , Perolla Adela , Çalliku Elsuarta , Petrela Elizana , Ivanaj Arben 
Published: December 2024

Background: Multiple Myeloma is a hematological malignancy characterised by progressive proliferation of plasma cells, resulting in the production of M protein and organ damage (bones, blood and kidneys).

Purpose: The main purpose is to document the real data of newly diagnosed patients with multiple myeloma in Albania who receive first-line treatment with VCd and VRd, January 2019-December 2023 (5 years), near the Hematology Service, University Hospital “Mother Teresa”, Albania.

Methods: This is a retrospective study. A total of 173 patients are included on the study which are divided into two groups regarding the two treatment schemes; VCd (Bortezomib, Cyclophosphamide, Dexametasone) 145 patients and VRd (Bortezomib, Lenalidomide, Dexametasone) 28 patients. This difference is because Lenalidomide is non-refundable in Albania and the choice of the treatment scheme depends on the economic possibilities of the patient. The main endpoints are the evidence of real data characteristics of myeloma, the classification/staging and the response to VCd, VRd treatment according to the IMWG, and the evaluation of overall survival (OS), progression free survival (PFS), as well as the estimated mean survival time. The assessment of OS/PFS was made in restrictive criteria; the newly diagnosed patients were in remission at the end of the study or they were under treatment or patients died from other causes during or after treatment.

Findings: The mean age is 64.5 years old, and the median age is 65 years old. About 39.3% belong to the 65-74 age group. Men are more affected compared to women (57% versus 43%). The most frequent clinical presentations are bone pain, fatigue (90% and 81%). Less frequent but with diagnostic significance are oliguria/anuria, peripheral polyneuropathy, and symptoms from hyperviscosity. From the data for the CRAB criteria, it is found anemia in 52%, hypercalcemia in 5%, serum creatinine &gt;2 mg/dL in 20%, osteolytic lesions in 100%, plasmacytoma in 12,7%, and presence of &gt;10 % plasma cell in bone marrow in 98,2%. In the peripheral blood, 76% have no plasma cell and only 2 cases have &gt;5 % plasma cells. The most frequent types of myeloma are IgG kappa 67.1%, and 4% of patients have non-secretory myeloma. According to the ISS, 65,9% are in stage 3 and 34.1% are in stage 2, and according to Durie-Salmon staging, 61,8% are in stage IIA, 8.1% in stage IIB, 16,2% in stage IIIA, and 13,9% in stage IIIB.

The evaluation of treatment response and OS/PFS was done separately according to treatment regimens. The complete/partial remission rate (ORR) is 84,1% for VCd and 89,4% for VRd. Among these patients, 21% have continued maintenance treatment with Bortezomib or Lenalidomide, and 38% in total ( 32% under treatment with VCd and 7% under treatment with VRd) have relapse/progression. The mean OS for all patients is 11.78 months, while in VCd it is 12.7 months and in VRd it is 7.04 months. While the median OS is 8 months, for both treatment regimens, without any statistcally significant difference between treatment lines. The mean PFS is 14.88 months, while for VCd it is 15.37 months and for VRd it is 7 months. The median PFS is 10.5 months for VCd, while for VRd cannot be estimated due to restrictions. The estimated mean survival time is predicted to be 21.1 ± 2.3 months, without any statistically significant difference between the lines of treatment (Log Rank test, p=0.099). The estimated mean survival time is 21.6 ± 2.3 months for VCd and it is 7 months for VRd. Meanwhile, the estimated median survival time is 21±6.9 months in total. For VCd it is 21 ± 5.69 , while for VRd it is not estimated due to restrictions. The most frequent complicating events during treatment were infection in 31.2%, thrombosis in 2.3%.

Conclusions: All the reported data demonstrate all the diagnostic and staging criteria. In relation to the prognostic criteria, we have partial data due to the lack of cytogenetic analysis. The reported results showed that VRd has a better response/OS than VCd with a small difference. While in relation to PFS and estimated mean survival time, the evaluation can only be done for te VCd and not VRd; this due to limitations. In Albania, VCd/VRd remain important schemes for the management of newly diagnosed myeloma. Although VRd is associated with a decrease in the risk of treatment failure, the use of it depends on the economic possibilities of the patients.