Summary of selected dara trials for RRAL and RRMM
| . | BU2 (n = 22) . | France1 (n = 40) . | Germany DD3 (n = 106) . | Germany DVD3 (n = 62) . | RRMM4 (n = 148) . |
|---|---|---|---|---|---|
| Study design | Phase 2 | Phase 2 | Consecutive patients | Phase 1/2 | |
| Eligibility | RRAL, NT-proBNP 8500, BMPC <30% | RRAL | RRMM | ||
| Months from last therapy | 9 | 5 | 2 | 1 | NA |
| Prior therapies, n | 2 | 3 | 2 | 1 | 5 |
| ASCT, % | Majority | 0 | 23 | 8 | 78 |
| Planned therapy | 24 m | 24 wk | Not specified, but median 14 infusions | Indefinite | |
| Corticosteroid | MP 60 to 100 pre and 20 to 80 post | MP 100 mg or Dex 20 mg with each dara dose | Dex 20 mg with each dara dose | Dex and weekly Bortez 4 of 5 wk | MP 60-100 pre and 40 post |
| dFLC, mg/L | 81 | 164 | 136 | 117 | NA |
| BMPC >30%, % | 0 | 0 | NA, >30% not excluded | 32 | |
| NT-proBNP, ng/L (>8500 ng/L, %) | 1264 (0) | 917 (0) | 4155 (34) | 5475 (40) | NA |
| eGFR <60, % | NA | 52 | <50: 54% | <50: 53% | 40 |
| Follow-up, mo | 20 | 26 | 21 | 17 | 21 |
| Hematologic response, overall, % | 90 (best) | 70 (best) | 64 (at 3 mo) | 66 (at 3 mo) | 31 (best) |
| CR/VGPR/PR, % | 41/45/4.5 | 15/42/12 | 8/48/8 | 11/55/0 | 5/9/18 |
| Organ response | Best | Best | At 6 mo | At 6 mo | NA |
| Renal, n (%) | 10 (67) | 8 (31) | 10 (24) | 7 (24) | |
| Cardiac, n (%) | 7 (50) | 7 (29) | 15 (22) | 11 (26) | |
| Hem PFS/OS, mo | 28/NR | 25/NR | 12/26 | 19/NR | PFS 4/20 |
| . | BU2 (n = 22) . | France1 (n = 40) . | Germany DD3 (n = 106) . | Germany DVD3 (n = 62) . | RRMM4 (n = 148) . |
|---|---|---|---|---|---|
| Study design | Phase 2 | Phase 2 | Consecutive patients | Phase 1/2 | |
| Eligibility | RRAL, NT-proBNP 8500, BMPC <30% | RRAL | RRMM | ||
| Months from last therapy | 9 | 5 | 2 | 1 | NA |
| Prior therapies, n | 2 | 3 | 2 | 1 | 5 |
| ASCT, % | Majority | 0 | 23 | 8 | 78 |
| Planned therapy | 24 m | 24 wk | Not specified, but median 14 infusions | Indefinite | |
| Corticosteroid | MP 60 to 100 pre and 20 to 80 post | MP 100 mg or Dex 20 mg with each dara dose | Dex 20 mg with each dara dose | Dex and weekly Bortez 4 of 5 wk | MP 60-100 pre and 40 post |
| dFLC, mg/L | 81 | 164 | 136 | 117 | NA |
| BMPC >30%, % | 0 | 0 | NA, >30% not excluded | 32 | |
| NT-proBNP, ng/L (>8500 ng/L, %) | 1264 (0) | 917 (0) | 4155 (34) | 5475 (40) | NA |
| eGFR <60, % | NA | 52 | <50: 54% | <50: 53% | 40 |
| Follow-up, mo | 20 | 26 | 21 | 17 | 21 |
| Hematologic response, overall, % | 90 (best) | 70 (best) | 64 (at 3 mo) | 66 (at 3 mo) | 31 (best) |
| CR/VGPR/PR, % | 41/45/4.5 | 15/42/12 | 8/48/8 | 11/55/0 | 5/9/18 |
| Organ response | Best | Best | At 6 mo | At 6 mo | NA |
| Renal, n (%) | 10 (67) | 8 (31) | 10 (24) | 7 (24) | |
| Cardiac, n (%) | 7 (50) | 7 (29) | 15 (22) | 11 (26) | |
| Hem PFS/OS, mo | 28/NR | 25/NR | 12/26 | 19/NR | PFS 4/20 |
ASCT, autologous stem cell transplant; BMPC, bone marrow plasma cell; BU, Boston University; CR, complete response; Dex, dexamethasone; dFLC, absolute difference between κ and λ ALs; Hem,; MP, methylprednisolone; NA, not applicable or not available; NT-proBNP, N-terminal pro-brain natriuretic peptide; OS, overall survival.