TY - JOUR AU - Jesus F. San Miguel, AU - Katja C. Weisel, AU - Kevin W. Song, AU - Michel Delforge, AU - Lionel Karlin, AU - Hartmut Goldschmidt, AU - Philippe Moreau, AU - Anne Banos, AU - Albert Oriol, AU - Laurent Garderet, AU - Michele Cavo, AU - Valentina Ivanova, AU - Adrian Alegre, AU - Joaquin Martinez-Lopez, AU - Christine Chen, AU - Christoph Renner, AU - Nizar Jacques Bahlis, AU - Xin Yu, AU - Terri Teasdale, AU - Lars Sternas, AU - Christian Jacques, AU - Mohamed H. Zaki, AU - Meletios A. Dimopoulos, PY - 2015/10/02 Y2 - 2024/03/28 TI - 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 JF - Haematologica JA - haematol VL - 100 IS - 10 SE - Articles DO - 10.3324/haematol.2015.125864 UR - https://haematologica.org/article/view/7528 SP - 1334-1339 AB - 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. ER -