Change search
ReferencesLink to record
Permanent link

Direct link
Thalidomide and dexamethasone vs. bortezomib and dexamethasone for melphalan refractory myeloma: a randomized study.
Department of Medicine, Lidköping Hospital, Lidköping, Sweden. (Nordic Myeloma Study Group (NMSG))
Department of Hematology, St Olavs University Hospital, and Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway. (Nordic Myeloma Study Group (NMSG))
Department of Hematology, Odense University Hospital, Odense, Denmark. (Nordic Myeloma Study Group (NMSG))
Department of Hematology and Faculty Division, Ullevål University Hospital, Oslo, Norway. (Nordic Myeloma Study Group (NMSG))
Show others and affiliations
2012 (English)In: European Journal of Haematology, ISSN 0902-4441, E-ISSN 1600-0609, Vol. 88, no 6, 485-496 p.Article in journal (Refereed) Published
Abstract [en]

Objectives:  Thalidomide and bortezomib have been frequently used for second-line therapy in patients with myeloma relapsing after or refractory to initial melphalan-based treatment, but no randomized trials have been published comparing these two treatment alternatives. Methods:  Thalidomide- and bortezomib-naïve patients with melphalan refractory myeloma were randomly assigned to low-dose thalidomide + dexamethasone (Thal-Dex) or bortezomib + dexamethasone (Bort-Dex). At progression on either therapy, the patients were offered crossover to the alternative drug combination. An estimated 300 patients would be needed for the trial to detect a 50% difference in median PFS between the treatment arms. Results:  After inclusion of 131 patients, the trial was prematurely closed because of low accrual. Sixty-seven patients were randomized to Thal-Dex and 64 to Bort-Dex. Progression-free survival was similar (median, 9.0 months for Thal-Dex and 7.2 for Bort-Dex). Response rate was similar (55% for Thal-Dex and 63% for Bort-Dex), but time to response was shorter (P < 0.05) and the VGPR rate higher (P < 0.01) for Bort-Dex. Time-to-other treatment after crossover was similar (median, 13.2 months for Thal-Dex and 11.2 months for Bort-Dex), as was overall survival (22.8 months for Thal-Dex and 19.0 for Bort-Dex). Venous thromboembolism was seen in seven patients and cerebrovascular events in four patients in the Thal-Dex group. Severe neuropathy, reactivation of herpes virus infections, and mental depression were more frequently observed in the Bort-Dex group. In the quality-of-life analysis, no difference was noted for physical function, pain, and global quality of life. Fatigue and sleep disturbances were significantly more prevalent in the Bort-Dex group. Conclusions:  Thalidomide (50-100 mg daily) in combination with dexamethasone seems to have an efficacy comparable with that of bortezomib and dexamethasone in melphalan refractory myeloma. However, the statistical strength of the results in this study is limited by the low number of included patients.

Place, publisher, year, edition, pages
John Wiley & Sons, 2012. Vol. 88, no 6, 485-496 p.
Keyword [en]
multiple myeloma, thalidomide, bortezomib, randomized trial, quality of life
National Category
Cancer and Oncology
URN: urn:nbn:se:umu:diva-55752DOI: 10.1111/j.1600-0609.2012.01775.xPubMedID: 22404182OAI: diva2:529334
Available from: 2012-05-30 Created: 2012-05-30 Last updated: 2012-06-11Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Forsberg, Karin
By organisation
In the same journal
European Journal of Haematology
Cancer and Oncology

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 113 hits
ReferencesLink to record
Permanent link

Direct link