Table 2.
Selected trials discussed in the meeting.
| Clinical studies | Treatment arms | Sample size (no. of patients) | Primary efficacy measures |
|---|---|---|---|
| Bortezomib: key clinical trials in previously untreated MM patients | |||
| VISTA TRIAL (11) (Phase 3 study) | BTZ 1.3 mg/m2 + MP vs. MP alone | 682 | TTP: 24.0 months (BTZ + MP) |
| TTP: 16.6 months (MP alone) | |||
| IFM 2005-01 (12) (Phase 3 study) | VD (BTZ 1.3 mg/m2 + DEX 40 mg) vs. VAD | 482 | Post induction CR/nCR: 14.8% (VD) |
| Post induction CR/nCR: 6.4% (VAD) | |||
| GIMEMA Italian Myeloma Network (13) (Phase 3 study) | VTD (BTZ 1.3 mg/m2 + THAL + DEX 40 mg) vs. TD | 480 | Post induction CR/nCR: 31% (VTD) |
| Post induction CR/nCR: 11% (TD) | |||
| HOVON-65/GMMG-HD4 (14) (Phase 3 study) | PAD (BTZ 1.3 mg/m2 + DOX + DEX 40 mg) vs. VAD | 827 | PFS: 35 months (PAD) |
| PFS: 28 months (VAD) | |||
| Bortezomib: key clinical trials in relapsed/refractory multiple myeloma (RRMM) | |||
| SUMMIT (Phase 2 study) (15) | BTZ 1.3 mg/m2 | 193 | ORR: 35% |
| CREST (16) (Phase 2 study) | BTZ 1.3 mg/m2 | 54 | ORR: 50% (1.3 mg/m2) |
| BTZ 1.0 mg/m2 | ORR: 33% (1.0 mg/m2) | ||
| APEX TRIAL (17) (Phase 3 study) | BTZ 1.3 mg/m2 vs. high-dose DEX 40 mg | 669 | TTP: 6.22 months (BTZ) |
| TTP: 3.49 months (high-dose DEX) | |||
| Pegylated liposomal doxorubicin + bortezomib (Phase 3 study) (18) | PLD 30 mg/m2 + BTZ 1.3 mg/m2 vs. BTZ 1.3 mg/m2 | 646 | TTP: 9.3 months (PLD + BTZ) |
| TTP: 6.5 months (BTZ) | |||
VISTA, Velcade as initial standard therapy in multiple myeloma: assessment with melphalan and prednisone; BTZ, bortezomib; MP: melphalan, prednisolone; TTP, time to progression; DEX, dexamethasone; VAD, vincristine, adriamycin, dexamethasone; CR/nCR, complete response/near complete response; THAL, thalidomide; DOX, doxorubicin; SUMMIT, study of uncontrolled multiple myeloma managed with proteasome inhibition therapy; CREST, clinical response and efficacy study of bortezomib in the treatment of relapsing multiple myeloma; APEX, assessment of proteasome inhibition for extending remissions; ORR, overall response rate; PLD, pegylated liposomal doxorubicin.