A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myeloma

The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial. A systematic review of the published clinical trials of these patients could reduce the possible bias of single phase-II studies. A systematic search i...

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Main Authors: Glasmacher, Axel (Author) , Hahn, Corinna (Author) , Hoffmann, Florian (Author) , Naumann, Ralph (Author) , Goldschmidt, Hartmut (Author) , Lilienfeld-Toal, Marie von (Author) , Orlopp, Katjana (Author) , Schmidt-Wolf, Ingo (Author) , Gorschlüter, Marcus (Author)
Format: Article (Journal)
Language:English
Published: 26 January 2006
In: British journal of haematology
Year: 2006, Volume: 132, Issue: 5, Pages: 584-593
ISSN:1365-2141
DOI:10.1111/j.1365-2141.2005.05914.x
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/j.1365-2141.2005.05914.x
Verlag, lizenzpflichtig, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2141.2005.05914.x
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Author Notes:Axel Glasmacher, Corinna Hahn, Florian Hoffmann, Ralph Naumann, Hartmut Goldschmidt, Marie von Lilienfeld-Toal, Katjana Orlopp, Ingo Schmidt-Wolf, Marcus Gorschlüter

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520 |a The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial. A systematic review of the published clinical trials of these patients could reduce the possible bias of single phase-II studies. A systematic search identified 42 communications reporting on 1674 patients. Thirty-two trials used an escalating dosing regimen and four a fixed dose regimen (one dose with 50 mg/d, three doses with 200 mg/d). The target dose in the dose escalating trials was 800 mg/d in 17 trials, 400-600 mg/d in 10 and 200 mg/d in one trial. The intention-to-treat population for efficacy was 1629 patients with a median age of 62 years. The complete and partial (>50% reduction in monoclonal protein) response rate was 29·4% (95%-confidence interval, 27-32%). The rates for minor responses or stable disease were 13·8% (12-16%) and 11·0% (9-13%). Progressive disease was reported in 9·9% (8-11%). The median overall survival from all trials was reported at 14 months. Severe adverse events (grade III-IV) included somnolence 11%, constipation 16%, neuropathy 6%, rash 3%, thrombo-embolism 3%, cardiac 2%. In conclusion, thalidomide monotherapy achieved complete and partial responses in 29·4% of patients with relapsed or refractory multiple myeloma. 
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