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SALVAGE THERAPY WITH POMALIDOMIDE-BASED REGIMEN IN RELAPSED/REFRACTORY MYELOMA. EFFICACY, AND SAFETY RESULTS.
Author(s): ,
Maialen Sirvent Auzmendi
Affiliations:
Hospital Universitario Donostia,San Sebastian,Spain
,
Susana Herraez Rodriguez
Affiliations:
Hospital Basurto,Bilbao,Spain
,
Ernesto Perez Persona
Affiliations:
Hospital Txagorritxu,Vitoria,Spain
,
Nerea Caminos Altuna
Affiliations:
Hospital Universitario Donostia,San Sebastian,Spain
,
Iratxe Urreta Barallobre
Affiliations:
Epydemiology,San Sebastian,Spain
,
Esther Perez Santaolalla
Affiliations:
Hospital Universitario Donostia,San Sebastian,Spain
,
Izaskun Ceberio Echechipia
Affiliations:
Hospital Universitario Donostia,San Sebastian,Spain
Maria Araiz Ramirez
Affiliations:
Hospital Universitario Donostia,San Sebastian,Spain
(Abstract release date: 05/17/18) EHA Library. Sirvent Auzmendi M. 06/14/18; 216454; PB2234
Maialen Sirvent Auzmendi
Maialen Sirvent Auzmendi
Contributions
Abstract

Abstract: PB2234

Type: Publication Only

Background

The combination of pomalidomide and low-dose dexamethasone has proved to be effective and safe in patients with end-stage relapsed/refractory multiple myeloma (RRMM), otherwise characterized by a very poor outcome. MM remains an incurable disease with unavoidable relapses. However, with the new therapeutic approaches available to date, prolonged survival of patients has been demostrated. Pomalidomide is a distinct immunomodulatory drug with potent antimyeloma activity, and has demonstrated efficacy even in patients that are refractory to Lenalidomide. In order to increase response rate, commonly it is used in combination.

Aims

We analize retrospectively, in a real-worl clinical practice setting, the efficacy, and safety of a pomalidomide-based regimens in patients with RRMM, treated in 3 centers. We evaluated the efficacy either when given with dexamethasone in 23 patients or in combination with oral cyclophsphamide +/- claritromycin in 25 patients. We evaluated the impact of adverse prognostic factors of cytogenetics and refractoriness to previous lenalidomide.

Methods

This multicenter estudy included fourty eight patients treated with Pomalidomide-based regimen for RRMM, between 2013-2017.

Results
 

Overall response rate (ORR) was 55.4% including CR 4.4%, VGPR in 24.4%, and PR in 26.6% patients. 13.3% showed stable disease, and 31% progression. There was no significant difference in patients who received pomalidomide in combination vs alone with dexamethasone, in terms of ORR (66.6% vs 71.43%, p 0.75) and PFS (mean 7.2 vs 8.5 months, p 0.55). If the treatment was given early (at second, third or four line) there was a trend towars improved PFS (mean 8.6 vs 5.8 months at ≥5 lines), but was not statistically significant (p 0.24). 
Lenalidomide refractory patients present disease progression in 38.24% and ORR in 50%. In patients whithout refractoriness, all of them had response (p0.043). The mean PFS was 10 months in the non-refractory vs 5 month in the refractory group (p 0.11).There was no significant difference in ORR and mean PFS was 8.4 vs 7.1 months in standar vs high risk citogenetic groups (p0.62).
The most common adverse events were infections (19.1%), cytopenias (10.6%) and inestability (6.4%). 12 patients (25%) need dose reduction and 5 (10.4%) had to discontinued because of AEs.

 

Conclusion

Pomalidomide-based treatment is effective, even in heavily treated RRMM, and adverse citogenetic group. In our study there was no benefit from using pomalidomide in combination with oral cyclophosphamide +/- claritromycin, but this should be confirmed in further studies. Lenalidomide refractory patients had shorter progressión free survival.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Myeloma, Relapse, Treatment

Abstract: PB2234

Type: Publication Only

Background

The combination of pomalidomide and low-dose dexamethasone has proved to be effective and safe in patients with end-stage relapsed/refractory multiple myeloma (RRMM), otherwise characterized by a very poor outcome. MM remains an incurable disease with unavoidable relapses. However, with the new therapeutic approaches available to date, prolonged survival of patients has been demostrated. Pomalidomide is a distinct immunomodulatory drug with potent antimyeloma activity, and has demonstrated efficacy even in patients that are refractory to Lenalidomide. In order to increase response rate, commonly it is used in combination.

Aims

We analize retrospectively, in a real-worl clinical practice setting, the efficacy, and safety of a pomalidomide-based regimens in patients with RRMM, treated in 3 centers. We evaluated the efficacy either when given with dexamethasone in 23 patients or in combination with oral cyclophsphamide +/- claritromycin in 25 patients. We evaluated the impact of adverse prognostic factors of cytogenetics and refractoriness to previous lenalidomide.

Methods

This multicenter estudy included fourty eight patients treated with Pomalidomide-based regimen for RRMM, between 2013-2017.

Results
 

Overall response rate (ORR) was 55.4% including CR 4.4%, VGPR in 24.4%, and PR in 26.6% patients. 13.3% showed stable disease, and 31% progression. There was no significant difference in patients who received pomalidomide in combination vs alone with dexamethasone, in terms of ORR (66.6% vs 71.43%, p 0.75) and PFS (mean 7.2 vs 8.5 months, p 0.55). If the treatment was given early (at second, third or four line) there was a trend towars improved PFS (mean 8.6 vs 5.8 months at ≥5 lines), but was not statistically significant (p 0.24). 
Lenalidomide refractory patients present disease progression in 38.24% and ORR in 50%. In patients whithout refractoriness, all of them had response (p0.043). The mean PFS was 10 months in the non-refractory vs 5 month in the refractory group (p 0.11).There was no significant difference in ORR and mean PFS was 8.4 vs 7.1 months in standar vs high risk citogenetic groups (p0.62).
The most common adverse events were infections (19.1%), cytopenias (10.6%) and inestability (6.4%). 12 patients (25%) need dose reduction and 5 (10.4%) had to discontinued because of AEs.

 

Conclusion

Pomalidomide-based treatment is effective, even in heavily treated RRMM, and adverse citogenetic group. In our study there was no benefit from using pomalidomide in combination with oral cyclophosphamide +/- claritromycin, but this should be confirmed in further studies. Lenalidomide refractory patients had shorter progressión free survival.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Myeloma, Relapse, Treatment

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