Publicaciones científicas

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

09-jul-2015 | Revista: Haematologica

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).


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. NCT01311687; EudraCT: 2010-019820-30.

CITA DEL ARTÍCULO  Haematologica. 2015 Jul 9. pii: haematol.2015.125864.