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Author year | Trial design | Therapy | Number and type of patients | Outcome |
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Hjorth et al. 1993 [7] | RCT | Initial versus deferred MP | 50 stage I MM (DSS) | No difference in RR, response duration, or OS |
|
Riccardi et al. 2000 and 1994 [5, 6] | RCT | Initial versus deferred MP | 145 stage I MM (DSS) | No difference in RR or OS |
|
Rajkumar et al. 2003 [8] | Single-arm phase 2 | Thalidomide | 16 SMM or IMM | 11 of 16 patients responded to therapy |
|
Martín et al. 2002 [32] | Single-arm pilot | Pamidronate | 12 SMM or IMM | Reduces bone turnover but has no antitumour effect |
|
Weber et al. 2003 [9] | Single-arm phase 2 | Thalidomide | 28 SMM | RR was 36% and median time to remission was 4.2 m |
|
Musto et al. 2008 [35] | RCT | Zoledronic acid versus observation | 163 SMM | No difference in PFS and TTP; reduce skeletal-related events |
|
Barlogie et al. 2008 [10] | Phase 2 | Thalidomide with monthly pamidronate | 76 SMM | 4-y OS and PFS were 91% and 60%, respectively |
|
D’Arena et al. 2011 [33] | RCT | Pamidronate versus observation | 177 SMM | No difference in PFS, TTP, or OS; reduce skeletal events |
|
Witzig et al. 2013 [11] | RCT | Thalidomide plus zoledronic acid versus zoledronic acid | 68 SMM | Significant difference in TTP and PFS; no difference in OS |
|
Mateos et al. 2013 [12] | RCT | Lenalidomide plus dexamethasone versus observation | 119 high-risk SMM | TTP: treatment: not reached; observation: 21 m; 3-y OS: treatment: 94%; observation: 80% |
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