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: | , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
26 January 2006
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| 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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| 245 | 1 | 2 | |a A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myeloma |c 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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