Tolerability and safety of real‑world use of pomalidomide in patients with relapsed/refractory multiple myeloma

Abstract

Pomalidomide (POM) is a second-generation immunomodulatory agent with proven efficacy in patients with relapsed/refractory multiple myeloma (RRMM) proven to be refractory to previous treatment with lenalidomide (LEN) and bortezomib. We herein conducted a retrospective analysis of 14 RRMM patients receiving POM to determine its tolerability and safety in the clinical setting. The median age of the patients was 72 years (range, 58-84 years), and 85.7% of the patients were aged >70 years. The most frequent treatment dose was 3 mg/day. POM dose reductions were required in 54.5% (6/11) of the patients. The patient data were compared among three age groups (<70, 70-75 and >75 years) and there was only significant difference in daily POM treatment dose. The tolerability of POM must be confirmed, particularly in elderly patients. Dose reduction from 4 to 3 mg occurred during the second cycle in 83.3% (5/6) of the patients. It is important to determine the tolerability of POM in the early phases of treatment. The most frequently reported grade 3/4 hematological adverse events were neutropenia (64.3%), anemia (64.3%) and thrombocytopenia (57.1%). Although the median number of treatment cycles was 4 (range, 1-13), 21.4% (3/14) of the patients with a performance status (PS) of 3 were administered only 1 treatment cycle. The tolerability of POM was low among patients with poor PS and an aggressive treatment introduction should be avoided. However, 21.4% (3/14) of the patients were able to continue treatment for >1 year and some patients received long-term therapy. POM does not require dose modification for renal function, and multiple capsule doses are available, which is an advantage of POM compared with LEN. POM may be administered to late-stage RRMM patients in a real-world clinical setting, but elderly patients or those with poor PS must be treated with caution. In this manner, the treatment options for RRMM patients may be expanded by assessing the tolerability and safety of POM.

Pomalidomide Treatment in Relapsed/Refractory Multiple Myeloma Patients—Real-World Data From Hungary

“…A Japanese group reported on a cohort of 14 RR MM patients who received pomalidomide in combination with low-dose dexamethasone. Unfortunately the pomalidomide therapy was poorly tolerated in this heavily pretreated group, and only 21.4% of the patients were able to continue treatment over 1 year [ 10 ]. An Italian working group analyzed the data of 121 MM patients who were administered pomalidomide and low-dose dexamethasone as a median fourth-line therapy.…”

Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis

“…In contrast with lenalidomide [ 6 ], pomalidomide can be safely administered to patients with RI without dose modification [ 26 ], and has previously been investigated in subgroups of patients with RI. Similar renal responses to the Pd arm of ICARIA-MM were observed in a subgroup analysis of the phase 3 MM-003 trial comparing Pd versus high-dose dexamethasone in RRMM [ 17 ].…”

Clinical Benefit of Long-Term Disease Control with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

“…Interestingly, almost half of patients obtained a PFS which exceeded the PFS obtained with previous treatment, reverting the typical clinical course of MM characterized by decreased durability of response at each successive salvage regimen [19]. In all real-life experiences [16,18,19,34,35,36,37], there is a sub-group of patients in which continued exposure to poma resulted in stable disease that can be translated in survival prolongation. Most of these patients achieved only a minimal-partial response demonstrating the relevance of maintaining response rather than deepening response in a specific cohort of patients.…”