Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma
San Miguel JF(1), Weisel KC(2), Song KW(3), Delforge M(4), Karlin L(5), Goldschmidt H(6), Moreau P(7), Banos A(8), Oriol A(9), Garderet L(10), Cavo M(11), Ivanova V(12), Alegre A(13), Martinez-Lopez J(14), Chen C(15), Renner C(16), Bahlis NJ(17), Yu X(18), Teasdale T(18), Sternas L(18), Jacques C(18), Zaki MH(18), Dimopoulos MA(19).
(1) Clinica Universidad de Navarra, CIMA;
(2) University Hospital Tubingen;
(3) Vancouver General Hospital;
(4) University Hospital Leuven;
(5) Centre Hospitalier Lyon Sud/Hospices Civils de Lyon;
(6) University Hospital Heidelberg and German Cancer Research Center;
(7) University Hospital Hotel-Dieu;
(8) Centre Hospitalier de la Cote Basque;
(9) Institut Catala d' Oncologia, HGTiP;
(10) Hopital Saint Antoine;
(11) Bologna University School of Medicine, Institute of Hematology and Medical Oncology;
(12) GUZ Moscow City Clinical Hospital S.P. Botkin;
(13) Hospital Universitario La Princesa;
(14) Hospital Universitario 12 de Octubre;
(15) Princess Margaret Hospital;
(16) University Hospital Zurich;
(17) University of Calgary;
(18) Celgene Corporation;
(19) Alexandra Hospital.
Date: Jul 9, 2015Haematology and Hameotherapy
Pomalidomide is a distinct oral IMiD immunomodulatory agent with direct antimyeloma, stromal-support inhibitory, and immunomodulatory effects. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and lenalidomide treatment.
Initial results demonstrated significantly longer progression-free survival and overall survival with an acceptable tolerability profile for pomalidomide + low-dose dexamethasone vs high-dose dexamethasone. This secondary analysis describes patient outcomes by treatment history and depth of response. Pomalidomide + low-dose dexamethasone significantly prolonged progression-free survival and favored overall survival vs high-dose dexamethasone for all subgroups analyzed, regardless of prior treatments or refractory status.
Both univariate and multivariate analyses showed that no variable relating to either the number (≤ or > 3) or type of prior treatment was a significant predictor of progression-free survival or overall survival. No cross-resistance with prior lenalidomide or thalidomide treatment was observed. Patients achieving a minimal response or better to pomalidomide + low-dose dexamethasone treatment experienced a survival benefit, which was even higher in those achieving at least a partial response (17.2 and 19.9 months, respectively, as compared with 7.5 months for patients with less than minimal response).
These data suggest that pomalidomide + low-dose dexamethasone should be considered a standard of care in patients with refractory or relapsed and refractory multiple myeloma regardless of prior treatment. ClinicalTrials.gov: NCT01311687; EudraCT: 2010-019820-30.
CITATION Haematologica. 2015 Jul 9. pii: haematol.2015.125864.
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