Ongoing studies of novel therapies in AL amyloidosis
| Drug . | Mechanism of action . | Trial identifier . | Phase . | Population . | Enrollment target . |
|---|---|---|---|---|---|
| Cael-101 | Fibril-directed therapy Anti–light chain antibody | NCT04304144 | 2 (part A with VCD; part B with DVCD) | NDAL | 25 |
| Cael-101 | Fibril-directed therapy Anti–light chain antibody | NCT04512235 | 3 (randomized, double blind) | NDAL (IIIA) | 267 |
| Cael-101 | Fibril-directed therapy Anti–light chain antibody | NCT04504825 | 3 (randomized, double blind) | NDAL (IIIB) | 111 |
| Doxycycline | Fibril-directed therapy Fibril stabilizer | NCT03474458 | 2/3 | NDAL | 120 |
| Isatuximab | Plasma cell–directed therapy Anti-CD38 monoclonal antibody | NCT04754945 | 1 | NDAL (high risk = Mayo 2012 stage IV, Mayo 2004 IIIB BUMC 2019 3B) | 25 |
| Isatuximab | Plasma cell–directed therapy | NCT03499808 | 2 | R/R | 43 |
| Venetoclax | Plasma cell–directed therapy BCL2 inhibitor | NCT02994784 | 1 | R/R | 24 |
| Belantamab | Plasma cell–directed therapy Anti-BCMA antibody drug conjugate | NCT04617925 | 2 | R/R | 35 |
| Melflufen | Plasma cell–directed therapy Alkylating agent | NCT04115956 | 1/2 | R/R (after 1L) | 46 |
| STI-6129 | Plasma cell–directed therapy Anti-CD38 antibody drug conjugate | NCT04316442 | 1 | R/R (≥2) | 60 |
| Drug . | Mechanism of action . | Trial identifier . | Phase . | Population . | Enrollment target . |
|---|---|---|---|---|---|
| Cael-101 | Fibril-directed therapy Anti–light chain antibody | NCT04304144 | 2 (part A with VCD; part B with DVCD) | NDAL | 25 |
| Cael-101 | Fibril-directed therapy Anti–light chain antibody | NCT04512235 | 3 (randomized, double blind) | NDAL (IIIA) | 267 |
| Cael-101 | Fibril-directed therapy Anti–light chain antibody | NCT04504825 | 3 (randomized, double blind) | NDAL (IIIB) | 111 |
| Doxycycline | Fibril-directed therapy Fibril stabilizer | NCT03474458 | 2/3 | NDAL | 120 |
| Isatuximab | Plasma cell–directed therapy Anti-CD38 monoclonal antibody | NCT04754945 | 1 | NDAL (high risk = Mayo 2012 stage IV, Mayo 2004 IIIB BUMC 2019 3B) | 25 |
| Isatuximab | Plasma cell–directed therapy | NCT03499808 | 2 | R/R | 43 |
| Venetoclax | Plasma cell–directed therapy BCL2 inhibitor | NCT02994784 | 1 | R/R | 24 |
| Belantamab | Plasma cell–directed therapy Anti-BCMA antibody drug conjugate | NCT04617925 | 2 | R/R | 35 |
| Melflufen | Plasma cell–directed therapy Alkylating agent | NCT04115956 | 1/2 | R/R (after 1L) | 46 |
| STI-6129 | Plasma cell–directed therapy Anti-CD38 antibody drug conjugate | NCT04316442 | 1 | R/R (≥2) | 60 |
DVCD, daratumumab, bortezomib, cyclophosphamide, dexamethasone; NDAL, newly diagnosed AL amyloidosis; R/R, relapsed/refractory; 1L, first line.