Clinical trials for smoldering myeloma
| Reference . | Type . | Treatment arms . | Best response . | Time to progression . |
|---|---|---|---|---|
| 20 | Single-arm phase 2 (n = 29) | Thalidomide 200 mg/d for 2 wk, and then increased as tolerated to a maximum dose of 800 mg/d | PR 34% | Median, 35 mo for PR 61 mo, MR 39 mo, and <MR 9 mo |
| 21 | Single-arm phase 2 (n = 78) | Thalidomide 200 mg/d with monthly pamidronate | PR 25% | 4-y EFS 60% |
| 22 | Randomized, placebo controlled | Curcumin 4 g followed by open-phase 8 g | NR | NR |
| 18 | Phase 3 randomized, placebo controlled (n = 119) | Lenalidomide 25 mg days 1-21, dexamethasone 20 mg days 1-4 and 12-15, for 9 4-wk cycles, followed by maintenance lenalidomide 10 mg days 1-21 of each 28-d cycle for 2 y | PR 79% induction, 90% maintenance | Median NR vs 21 mo |
| 3 y OS 94% vs 80% | ||||
| 23 | Single-arm phase 2 (n = 12) | Eight 28-d cycles of carfilzomib 20/36 mg/m2 on days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on days 1-21; and dexamethasone 20/10 mg (cycles 1-4/5-8) on days 1, 2, 8, 9, 15, 16, 22, and 23; followed by 24 cycles of lenalidomide | ≥VGPR 100% | NR |
| 24 | Single arm (n = 22) | 6 doses of PVX-410 vaccine (subcutaneous), biweekly ± 3 21-d cycles of lenalidomide, 25 mg, orally daily every 28 d | No PR single agent, 5/12 PR in combination | 9 mo, NR for combination |
| 25 | Single-arm phase 2 (n = 90) | Carfilzomib 20/36 mg/m2 days 1, 2, 8, 9, 15, 16; lenalidomide 25 mg days 1-21; dexamethasone 40 mg days 1, 8, 15, 22; followed by single ASCT with Mel200, followed by 2 cycles of KRd consolidation, followed by maintenance lenalidomide 10 mg days 1-21, dexamethasone 20 mg days 1, 8, 15, and 22 (24 4-wk cycles) | 100% PR, 90% CR | NR (PFS 94% at 28 mo) |
| Reference . | Type . | Treatment arms . | Best response . | Time to progression . |
|---|---|---|---|---|
| 20 | Single-arm phase 2 (n = 29) | Thalidomide 200 mg/d for 2 wk, and then increased as tolerated to a maximum dose of 800 mg/d | PR 34% | Median, 35 mo for PR 61 mo, MR 39 mo, and <MR 9 mo |
| 21 | Single-arm phase 2 (n = 78) | Thalidomide 200 mg/d with monthly pamidronate | PR 25% | 4-y EFS 60% |
| 22 | Randomized, placebo controlled | Curcumin 4 g followed by open-phase 8 g | NR | NR |
| 18 | Phase 3 randomized, placebo controlled (n = 119) | Lenalidomide 25 mg days 1-21, dexamethasone 20 mg days 1-4 and 12-15, for 9 4-wk cycles, followed by maintenance lenalidomide 10 mg days 1-21 of each 28-d cycle for 2 y | PR 79% induction, 90% maintenance | Median NR vs 21 mo |
| 3 y OS 94% vs 80% | ||||
| 23 | Single-arm phase 2 (n = 12) | Eight 28-d cycles of carfilzomib 20/36 mg/m2 on days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on days 1-21; and dexamethasone 20/10 mg (cycles 1-4/5-8) on days 1, 2, 8, 9, 15, 16, 22, and 23; followed by 24 cycles of lenalidomide | ≥VGPR 100% | NR |
| 24 | Single arm (n = 22) | 6 doses of PVX-410 vaccine (subcutaneous), biweekly ± 3 21-d cycles of lenalidomide, 25 mg, orally daily every 28 d | No PR single agent, 5/12 PR in combination | 9 mo, NR for combination |
| 25 | Single-arm phase 2 (n = 90) | Carfilzomib 20/36 mg/m2 days 1, 2, 8, 9, 15, 16; lenalidomide 25 mg days 1-21; dexamethasone 40 mg days 1, 8, 15, 22; followed by single ASCT with Mel200, followed by 2 cycles of KRd consolidation, followed by maintenance lenalidomide 10 mg days 1-21, dexamethasone 20 mg days 1, 8, 15, and 22 (24 4-wk cycles) | 100% PR, 90% CR | NR (PFS 94% at 28 mo) |
ASCT, autologous stem cell transplant; CR, complete response; EFS, event-free survival; KRd, carfilzomib, lenalidomide, and dexamethasone; MR, minor response; PFS, progression-free survival; PR, partial response; VGPR, very good partial response.