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Filanesib in combination with pomalidomide and dexamethasone in refractory MM patients: safety and efficacy, and association with alpha 1-acid glycoprotein (AAG) levels. Phase Ib/II Pomdefil clinical trial conducted by the Spanish MM group

Abstract: This phase I/II trial evaluated the combination of the kinesin spindle protein inhibitor filanesib with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma (RRMM) patients. Forty-seven RRMM patients with a median of three prior lines (2-8) and 94% refractory to lenalidomide were included: 14 in phase I and 33 in phase II. The recommended dose was 1·25 mg/m2 of filanesib on days 1, 2, 15, 16, with pomalidomide 4 mg on days 1-21 and dexamethasone 40 mg weekly. The defined threshold for success was achieved, with 18 out of 31 patients obtaining at least minor response (MR) in the phase II. In the global population, 51% of patients achieved at least partial response (PR) and 60% ?MR, resulting in a median progression-free survival (mPFS) of seven months and overall survival (OS) of 19 months. The main toxicity was haematological. Importantly, patients with low serum levels of alpha 1-acid glycoprotein (AAG) at baseline (<800 mg/l) had a superior response (overall response rate of 62% vs. 17%; P = 0·04), which also translated into a longer mPFS (9 vs. 2 months; P = 0·014). In summary, filanesib with pomalidomide and dexamethasone is active in RRMM although with significant haematological toxicity. Most importantly, high levels of AAG can identify patients unlikely to respond to this strategy. Trial registration: clinicaltrials.gov identifier: NCT02384083.

 Fuente: Br J Haematol . 2021 Feb;192(3):522-530.

Editorial: Blackwell Publishing Ltd

 Año de publicación: 2021

Nº de páginas: 9

Tipo de publicación: Artículo de Revista

 DOI: 10.1111/bjh.16788

ISSN: 0007-1048,1365-2141

Url de la publicación: https://doi.org/10.1111/bjh.16788

Autores/as

MOTLLÓ, CRISTINA

RODRÍGUEZ OTERO, PAULA

MARTÍNEZ LÓPEZ, JOAQUÍN

CEJALVO, MARÍA JOSÉ

MARTÍN SÁNCHEZ, JESÚS

BLADÉ, JOAN

GARCÍA MALO, MARÍA DOLORES

DOURDIL, MARÍA VICTORIA

GARCÍA MATEO, ARÁNZAZU

ARRIBA, FELIPE DE

GARCÍA SANZ, RAMÓN

RUBIA, JAVIER DE LA

ORIOL, ALBERT

LAHUERTA, JUAN JOSÉ

SAN MIGUEL, JESÚS F.

MATEOS, MARÍA VICTORIA