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GEM-POMCIDEX Study: Treatment of Patients with RRMM Using Pomalidomide, Cyclophosphamide, and Dexamethasone (POMCIDEX)

2020 Year in Review - Multiple Myeloma

This multicenter, retrospective, real-world study (GEM-POMCIDEX) was initiated to evaluate the effectiveness of the guidelines established by the Spanish Myeloma Group (PETHEMA) to treat appropriate patients with relapsed/refractory multiple myeloma (RRMM) with pomalidomide, cyclophosphamide, and dexamethasone (POMCIDEX).

The guidelines were provided to offer uniform management of relapsed patients and to improve the overall response rate (ORR), quality (depth and duration) of response, and progression-free survival (PFS).

There were 100 patients included in the study who were treated with the following POMCIDEX regimen: pomalidomide 4 mg on days 1 to 21, cyclophosphamide 50 mg/day, and dexamethasone 40 mg weekly (20 mg if patients were aged ≥75 years). Median age of the study cohort was 69 years (range, 39-86 years). Regarding prior treatments, 64.5%, 89%, and 60% of patients were refractory to proteasome inhibitors, refractory to lenalidomide, and double refractory, respectively; 57.6% of patients were refractory to lenalidomide as the last line of therapy. A total of 82% of patients were refractory to the last line of therapy.

For patients taking POMCIDEX according to the PETHEMA guidelines, ORR was 39%. Stringent complete response, complete response (CR), very good partial response, and partial response (PR) were achieved by 6%, 1%, 12%, and 20% of patients, respectively. The clinical benefit rate (≥stable response) was 93%. The ORR, when analyzed by subgroup according to prior medications, was consistently maintained with the exception of those receiving lenalidomide as their last line of therapy. These patients and those with extramedullary disease showed a lower ORR of 29.82% and 12.5%, respectively.

For the study population, median PFS was 7.6 months (95% confidence interval [CI], 5.78-10.12). For those who achieved at least a PR, PFS was significantly longer (10.4 months; 95% CI, 7.4-19.1) versus those who did not achieve PR (5.4 months; 95% CI, 3.9-8.1; hazard ratio [HR], 2.0; 95% CI, 1.3-3.1; P = .001). Median PFS was sustained for subgroups divided by prior medication; however, a significantly shorter median PFS was achieved for those with extramedullary disease of 5.4 months (95% CI, 2.8-7.3) versus 8.8 months (95% CI, 6.4-12.4) for those who did not have extramedullary disease (HR, 1.7; 95% CI, 1.05-2.75; P = .030).

A similar pattern was shared for median overall survival (12.6 months; 95% CI, 9.3-18.2), with those who achieved at least PR having significantly longer overall survival than those who did not, that is, 18.2 months (95% CI, 11.2-41.3) versus 9.85 months (95% CI, 7.1-14.0) (HR, 0.52; 95% CI, 0.3-0.8). As with PFS, median overall survival was sustained across all subgroups studied, except for the subgroup of patients with extramedullary disease.

In 43% and 79% of patients, hematologic and nonhematologic adverse events occurred. The primary reason for discontinuation was disease progression; only 2 patients discontinued because of adverse events. Of the patients enrolled in this study, 76% have died (57% due to disease progression, 6% due to adverse events). The authors concluded that POMCIDEX is an effective, manageable, and cost-effective treatment offering the attractive option of an all-oral administration route drug combination for patients with RRMM.

Abstract and Poster EP982. EHA 2020. June 12, 2020. Pomalidomide, cyclophosphamide and dexamethasone (POMCIDEX) for the treatment or relapse and refractory multiple myeloma (RRMM): real-world analysis of the PETHEMA-GEM experience.

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