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 and Thierry FACON. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. Haematologica-the Hematology Journal. PAVIA: FERRATA STORTI FOUNDATION, 2012, vol. 97, No 5, p. 784-791. ISSN 0390-6078. doi:10.3324/haematol.2011.044271.
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Basic information
Original name Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial
Authors KROPFF, Martin (276 Germany, guarantor), Honorata Giongco BAYLON (276 Germany), Jens HILLENGASS (276 Germany), Tadeusz ROBAK (616 Poland), Roman HÁJEK (203 Czech Republic, belonging to the institution), Peter LIEBISCH (276 Germany), Stefan GORANOV (276 Germany), Cyrille HULIN (276 Germany), Joan BLADE (276 Germany), Tommaso CARAVITA (276 Germany), Herve AVET-LOISEAU (276 Germany), Thomas M MOEHLER (276 Germany), Claire PATTOU (276 Germany), Lela LUCY (276 Germany), Elisabeth KUEENBURG (276 Germany), Axel GLASMACHER (276 Germany), Robert ZERBIB (276 Germany) and Thierry FACON (276 Germany).
Edition Haematologica-the Hematology Journal, PAVIA, FERRATA STORTI FOUNDATION, 2012, 0390-6078.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30200 3.2 Clinical medicine
Country of publisher Italy
Confidentiality degree is not subject to a state or trade secret
Impact factor Impact factor: 5.935
RIV identification code RIV/00216224:14110/12:00061480
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.3324/haematol.2011.044271
UT WoS 000304669000027
Keywords in English thalidomide; dexamethasone; multiple myeloma; prior therapy; time to progression
Tags International impact
Changed by Changed by: Mgr. Michal Petr, učo 65024. Changed: 25. 10. 2012 14:51.
Abstract
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)
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