Table 1 Details and data extraction of relapsed and/or refractory multiple myeloma phase III RCTs
Trial ID NCT number | Treatment (control versus experimental) | Median age (range) | Median prior lines (range) | N itt | # CR-group | # PR-group | # < PR-group | Duration |
|---|---|---|---|---|---|---|---|---|
GMY302 NCT00017602 | Dexamethasone Oblimersen + Dexamethasone | 65 (n/r-n/r) 59 (n/r-n/r) | 3 3 | 114 110 | 0 0 | 19 16 | 95 94 | Dec 2000—Apr 2009 |
APEX NCT00048230 | Dexamethasone Bortezomib | 61 (47–73) 62 (48–74) | 2 2 | 336 333 | 5 41 | 51 80 | 280 212 | Jun 2002—Dec 2004 |
MM-009 NCT00056160 | Dexamethasone Lenalidomide + Dexamethasone | 62 (37–85) 64 (38–86) | n/r n/r | 176 177 | 3 43 | 32 65 | 141 69 | Jan 2003—Oct 2008 |
MM-010 NCT00424047 | Dexamethasone Lenalidomide + Dexamethasone | 64 (40–82) 63 (33–84) | 2 2 | 175 176 | 9 43 | 33 63 | 133 70 | Sep 2003—Nov 2013 |
Orlowski NCT00103506 | Bortezomib Pegylated Liposomal Doxorubicin + Bortezomib | 62 (34–88) 61 (28–85) | n/r n/r | 322 324 | 8 14 | 125 130 | 189 180 | Dec 2004—Jun 2014 |
Garderet 2012 NCT00256776 | Thalidomide + Dexamethasone Bortezomib + Thalidomide + Dexamethasone | 63 (39–75) 60 (29–76) | n/r n/r | 134 135 | 25 56 | 61 52 | 48 27 | Jul 2005—Jun 2013 |
OPTIMUM NCT00452569 | Dexamethasone Thalidomidet | 63 (40–86) 63 (33–86) | n/r (1–3) n/r (1–3) | 126 373 | 2 7 | 23 53 | 101 313 | Feb 2006—Jan 2009 |
Hjorth 2012 NCT00602511 | Bortezomib + Dexamethasone Thalidomide + Dexamethasone | 71 (50–84) 71 (38–85) | n/r n/r | 64 67 | 0 0 | 40 37 | 24 30 | Oct 2007—Dec 2010 |
OPTIMISMM NCT0173492 | Bortezomib + Dexamethasone Pomalidomide + Bortezomib + Dexamethasone | 68 (59–73) 67 (60–73) | 2 (1–2) 2 (1–2) | 278 281 | 11 44 | 128 187 | 139 50 | Jan 2013—May 2017 |
PANORAMA1 NCT01023308 | Bortezomib + Dexamethasone Panobinostat + Bortezomib + Dexamethasone | 63 (56–68) 63 (56–69) | 2 (1–3) 2 (1–3) | 381 387 | 60 107 | 148 128 | 173 152 | Dec 2009—Jul 2015 |
ASPIRE NCT01080391 | Lenalidomide + Dexamethasone Carfilzomib + Lenalidomide + Dexamethasone | 65 (31–91) 64 (38–87) | 2 (1–3) 2 (1–3) | 396 396 | 37 126 | 227 219 | 132 51 | Jul 2010—Oct 2017 |
MM-003 NCT01311687 | Dexamethasone Pomalidomide + Dexamethasone | 65 (35–87) 64 (35–84) | 5 (2–17) 5 (2–14) | 153 302 | 0 3 | 15 92 | 138 207 | Mar 2011—Sep 2017 |
ELOQUENT-2 NCT01239797 | Lenalidomide + Dexamethasone Elotuzumab + Lenalidomide + Dexamethasone | 66 (38–91) 67 (37–88) | 2 (1–4) 2 (1–4) | 325 321 | 24 14 | 189 238 | 112 69 | Mar 2011—Mar 2018 |
ENDEAVOR NCT01568866 | Bortezomib + Dexamethasone Carfilzomib + Dexamethasone | 65 (30–88) 65 (35–89) | 2 (1–3) 2 (1–3) | 465 464 | 29 58 | 261 298 | 175 108 | Jun 2012—Dec 2018 |
Tourmaline-MM1 NCT01564537 | Lenalidomide + Dexamethasone Ixazomib + Lenalidomide + Dexamethasone | 66 (30–89) 66 (38–91) | n/r (1–3) n/r (1–3) | 362 360 | 24 42 | 235 240 | 103 78 | Aug 2012—Dec 2020 |
Pollux NCT02076009 | Lenalidomide + Dexamethasone Daratumumab + Lenalidomide + Dexamethasone | 65 (42–87) 65 (34–89) | 1 (1–8) 1 (1–11) | 283 286 | 54 123 | 162 143 | 67 20 | May 2014—Sep 2020 |
Castor NCT02136134 | Bortezomib + Dexamethasone Daratumumab + Bortezomib + Dexamethasone | 64 (33–85) 64 (30–88) | 2 (1–10) 2 (1–9) | 247 251 | 21 46 | 127 153 | 99 52 | Aug 2014—Mar 2017 |