immune checkpoint inhibition | pembrolizumab | versus No demonstrated result for efficacy pembrolizumab + pomadoline + dexamethasone inferior to pomadoline + dexamethasone in terms of PFS in KEYNOTE-183, 2018 (rrMM patients) | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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KEYNOTE-183, 2018 | pembrolizumab + pomadoline + dexamethasone vs pomadoline + dexamethasone | | PFS 1.53 [1.05; 2.22] median 7.8 mo vs. 8.6 mo | OS 1.61 [0.91; 2.85] median NR vs. 15.2 mo | KEYNOTE-185, 2018 | pembrolizumab, lenalidomide, dexametahsone vs lenalidomide, dexamethasone | | | |
Trial | Treatments | Patients | Method |
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KEYNOTE-183, 2018 | pembrolizumab, Pomalidomide and low-dose Dexamethasone (n=125) vs. Pomalidomide and low-dose Dexamethasone (n=124) | refractory or relapsed and refractory Multiple Myeloma (rrMM) | open-design Parallel groups Sample size: 125/124 Primary endpoint: FU duration: 7.8 mo / 8.6 mo (median) | KEYNOTE-185, 2018 | (n=151) vs. lenalidomide and low-dose dexamethasone (n=150) | newly diagnosed and treatment naïve Multiple Myeloma who are ineligible for autologous stem cell transplant Only 301 of the 640 planned had been enrolled when the trial was halted | open-design Parallel groups Sample size: 151/150 Primary endpoint: FU duration: |
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proteasome inhibitor | carfilzomib | versus No demonstrated result for efficacy | 5 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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ENDEAVOR, 2016 | carfilzomib vs bortezomib | OS 0.79 [0.65; 0.96] median 47.6 mo vs. 40.0 mo PFS 0.53 [0.44; 0.64] median 18.7 mo vs. 9.4 mo | | | ASPIRE, 2014 | carfilzomib lenalidomide dexamethasone vs lenalidomide and dexamethasone alone | OS 0.79 [0.63; 0.99] PFS 0.69 [0.57; 0.83] median 26.3 mo vs. 17.6 mo | | | FOCUS, 2017 | carfilzomib vs low-dose corticosteroids | | | OS 0.98 [0.76; 1.25] median 10.2 mo vs. 10.0 mo | ECOG-ACRIN | carfilzomib vs bortezomid | | | | CLARION | carfilzomib vs bortezomid | | | |
Trial | Treatments | Patients | Method |
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ENDEAVOR, 2016 | carfilzomib with dexamethasone (n=464) vs. bortezomib with dexamethasone (n=465) | patients with relapsed or refractory multiplemyeloma who had one to three previous treatments | open-label Sample size: 464/465 Primary endpoint: PFS FU duration: | ASPIRE, 2014 | carfilzomib with lenalidomide and dexamethasone (n=-9) vs. lenalidomide and dexamethasone alone (n=-9) | patients with relapsed multiple myeloma | open-label Sample size: -9/-9 Primary endpoint: PFS FU duration: | FOCUS, 2017 | carfilzomib monotherapy (n=157) vs. low-dose corticosteroids and optional cyclophosphamide (n=158) | relapsed and refractory multiple myeloma (RRMM) | open-label Parallel groups Sample size: 157/158 Primary endpoint: OS FU duration: | ECOG-ACRIN | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: | CLARION | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
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