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@article{1070354,
author = {Kropff, Martin and Baylon, Honorata Giongco and Hillengass, Jens and Robak, Tadeusz and Hájek, Roman and Liebisch, Peter and Goranov, Stefan and Hulin, Cyrille and Blade, Joan and Caravita, Tommaso and AvetandLoiseau, Herve and Moehler, Thomas M and Pattou, Claire and Lucy, Lela and Kueenburg, Elisabeth and Glasmacher, Axel and Zerbib, Robert and Facon, Thierry},
article_location = {PAVIA},
article_number = {5},
doi = {http://dx.doi.org/10.3324/haematol.2011.044271},
keywords = {thalidomide; dexamethasone; multiple myeloma; prior therapy; time to progression},
language = {eng},
issn = {0390-6078},
journal = {Haematologica-the Hematology Journal},
title = {Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial},
volume = {97},
year = {2012}
}
TY - JOUR
ID - 1070354
AU - Kropff, Martin - Baylon, Honorata Giongco - Hillengass, Jens - Robak, Tadeusz - Hájek, Roman - Liebisch, Peter - Goranov, Stefan - Hulin, Cyrille - Blade, Joan - Caravita, Tommaso - Avet-Loiseau, Herve - Moehler, Thomas M - Pattou, Claire - Lucy, Lela - Kueenburg, Elisabeth - Glasmacher, Axel - Zerbib, Robert - Facon, Thierry
PY - 2012
TI - Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial
JF - Haematologica-the Hematology Journal
VL - 97
IS - 5
SP - 784-791
EP - 784-791
PB - FERRATA STORTI FOUNDATION
SN - 03906078
KW - thalidomide
KW - dexamethasone
KW - multiple myeloma
KW - prior therapy
KW - time to progression
N2 - Background Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma. Design and Methods We conducted an international, randomized, open-label, four-arm, phase III trial to compare three different doses of thalidomide (100, 200, or 400 mg/day) with standard dexamethasone in patients who had received one to three prior therapies. The primary end-point was time to progression. Results In the intent-to-treat population (N=499), the median time to progression was 6.1, 7.0, 7.6, and 9.1 months in patients treated with dexamethasone, and thalidomide 100, 200, and 400 mg/day, respectively; the difference between treatment groups was not statistically significant. In the per-protocol population (n=465), the median time to progression was 6.0, 7.0, 8.0, and 9.1 months, respectively. In patients who had received two or three prior therapies, thalidomide significantly prolonged the time to progression at all dose levels compared to the result achieved with dexamethasone. Response rates and median survival were similar in all treatment groups, but the median duration of response was significantly longer in all thalidomide groups than in the dexamethasone group. Adverse events reported in the thalidomide groups, such as fatigue, constipation and neuropathy, confirmed the known safety profile of thalidomide. Conclusions Although thalidomide was not superior to dexamethasone in this randomized trial, thalidomide monotherapy may be considered an effective salvage therapy option for patients with relapsed/refractory multiple myeloma, particularly those with a good prognosis and those who have received two or three prior therapies. The recommended starting dose of thalidomide monotherapy is 400 mg/day, which can be rapidly reduced for patients who do not tolerate this treatment. (Clinical trial registration number: NCT00452569)
ER -
KROPFF, Martin, Honorata Giongco BAYLON, Jens HILLENGASS, Tadeusz ROBAK, Roman HÁJEK, Peter LIEBISCH, Stefan GORANOV, Cyrille HULIN, Joan BLADE, Tommaso CARAVITA, Herve AVET-LOISEAU, Thomas M MOEHLER, Claire PATTOU, Lela LUCY, Elisabeth KUEENBURG, Axel GLASMACHER, Robert ZERBIB a Thierry FACON. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. \textit{Haematologica-the Hematology Journal}. PAVIA: FERRATA STORTI FOUNDATION, 2012, roč.~97, č.~5, s.~784-791. ISSN~0390-6078. doi:10.3324/haematol.2011.044271.
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