Table 1.
Basic information of the eighteen included phase 3 randomized controlled trials
| Study | Trial name | IMiD used | ASCT status | No. of patients | Maintenance therapy regimen | Survival endpoint |
|---|---|---|---|---|---|---|
| Attal (2006) (19) | IFM 99 02 | Thalidomide | with | 201 | Pamidronate + thalidomide | EFS, OS |
| 196 | Pamidronate* | |||||
| 200 | No maintenance* | |||||
| Barlogie (2008) (20) | TT2 | Thalidomide | with | 323 | Thalidomide† + IFN-α + dexamethasone | EFS, OS |
| 345 | IFN-α + dexamethasone | |||||
| Palumbo (2008) (21) | GISMM2001-A | Thalidomide | without | 167 | Thalidomide† | PFS, OS |
| 164 | No maintenance | |||||
| Rajkumar (2008) (22) | THAL-MM-003 | Thalidomide | without | 234 | Thalidomide + dexamethasone | TTP, PFS, OS |
| 232 | Placebo + dexamethasone | |||||
| Lokhorst (2010) (23) | HOVON-50 | Thalidomide | with | 268 | Thalidomide† | PFS, OS |
| 268 | IFN-α | |||||
| Ludwig (2010) (24) | 01-002-0601 | Thalidomide | without | 64 | Thalidomide + IFN-α | PFS, OS |
| 64 | IFN-α | |||||
| Waage (2010) (25) | NMSG #12 | Thalidomide | without | 182 | Thalidomide† | PFS, OS |
| 175 | Placebo | |||||
| Wijermans (2010) (26) | HOVON-49 | Thalidomide | without | 165 | Thalidomide† | EFS, PFS, OS |
| 168 | No maintenance | |||||
| Maiolino (2012) (27) | GBRAM0001 | Thalidomide | with | 56 | Thalidiomide + dexamethasone | PFS, OS |
| 52 | Dexamethasone | |||||
| Mateos (2012) (28) | GEM2005MAS65 | Thalidomide | without | 91 | Bortezomib + thalidomide† | PFS, OS |
| 87 | Bortezomib + prednisone | |||||
| Morgan (2012) (29) | MRC Myeloma IX | Thalidomide | with | 245 | Thalidomide | PFS, OS |
| 247 | No maintenance | |||||
| without | 163 | Thalidomide | ||||
| 163 | No maintenance | |||||
| Stewart (2013) (30) | NCIC CTG MY.10 | Thalidomide | with | 166 | Thalidomide + prednisone | PFS, OS |
| 166 | No maintenance | |||||
| Zonder (2010) (31) | S0232 | Lenalidomide | without | 97 | Lenalidomide† + dexamethasone | PFS, OS |
| 95 | Placebo + dexamethasone | |||||
| Attal (2012) (32) | IFM 2005-02 | Lenalidomide | with | 307 | Lenalidomide | PFS, EFS, OS |
| 307 | Placebo | |||||
| McCarthy (2012) (33) | CALGB 100104 | Lenalidomide | with | 231 | Lenalidomide | TTP, OS |
| 229 | Placebo | |||||
| Palumbo (2012) (34) | MM-015 | Lenalidomide | without | 152 | Lenalidomide‡ | PFS, OS |
| 153 | Placebo‡ | |||||
| 154 | Placebo§ | |||||
| Benboubker (2014) (35) | FIRST | Lenalidomide | without | 535 | Lenalidomide + dexamethasoneǁ | PFS, OS |
| 541 | No maintenanceǁ | |||||
| 547 | No maintenance¶ | |||||
| Palumbo (2014) (36) | RV-MM-PI-209 | Lenalidomide | with | 57 | Lenalidomide | PFS, OS |
| 59 | No maintenance | |||||
| without | 59 | Lenalidomide | ||||
| 56 | No maintenance |
* Pamidronate and No maintenance arms were combined as control arm. ASCT = autologous stem cell transplantation; EFS = event-free survival; IMiD = immunomodulatory drug; OS = overall survival; PFS = progression-free survival; TTP = time to progression.
† Thalidomide, or lenalidomide, was also used during induction and/or consolidation therapy phases in experimental arms.
‡ Melphalan, prednisone, and thalidomide for nine cycles followed by lenalidomide or placebo maintenance.
§ Melphalan and prednisone for nine cycles, no maintenance therapy, data not used in this meta-analysis.
ǁ Lenalidomide and dexamethasone continuously or for 18 cycles only (No maintenance arm).
¶ Melphalan, prednisone, and thalidomide for 12 cycles, no maintenance therapy, data not used in this meta-analysis.