Table 2.
Ongoing clinical trials including MRD as a primary clinical endpoint.
| Identifier | Phase | Regimen | Subjects | Primary outcome measures | Sensitivity/method | Status |
|---|---|---|---|---|---|---|
| NCT04288765 | 3 | DaraKRd ± ASCT | 56 NDMM eligible or not for ASCT | MRD negativity rate | NR/MFC | Recruiting |
| NCT04287855 | 2 | Single arm: Isa-KPd | 90 R/R MM | MRD negativity rate | 10−5/NR | Not yet recruiting |
| NCT04268498 | 2 | DaraKRd vs. KRd vs. VRd | 462 NDMM | MRD negativity rate | NR | Recruiting |
| NCT04194931 | 1 | Single arm: BCMA-CART cells and CD19-CART cells |
20 R/R MM | ORR, MRD negativity rate, PFS, OS | NR | Recruiting |
|
NCT04191616 (SELECT) |
2 | Single arm: KPd | 85 R/R MM to R and previously exposed to Dara | MRD negativity rate | 10−5/NGS | Not yet recruiting |
| NCT04133636 | 2 | Single arm: JNJ-68284528 (BCMA CAR-T therapy) |
80 R/R MM | MRD negativity rate | 10−5/NR | Recruiting |
| NCT04124497 | 2 | Single arm: DaraPd | 45 R/R MM with del(17p) and not previously treated with Dara | MRD negativity rate | 10−5 /NGS (ClonoSEQ assay) |
Active, not recruiting |
| NCT04091126 | 3 | Belantamab Mafodotin+VRd vs. VRd alone | 810 NDMM non-eligible for ASCT | DLTs, SAEs, MRD negativity rate, PFS | 10−5 /NGS | Recruiting |
| NCT03948035 | 3 | Elo-KRd vs. KRd prior to and after ASCT and maintenance with Elo-R vs. R alone | 576 NDMM eligible for ASCT | MRD negativity rate, PFS | NR/MFC | Recruiting |
| NCT03896737 | 2 | DaraVCd vs. VTd prior to and after ASCT and maintenance with Dara-Ixa vs. Ixa alone | 400 NDMM | PFS, MRD negativity rate | 10−5 /NGS (ClonoSEQ assay) |
Recruiting |
|
NCT03815279 (iStopMM) |
2 | Intermediate-risk sMM: Rd High-risk sMM & MM: KRd |
80 sMM and MM | MRD negativity rate | NR/NGS | Enrolling by invitation |
| NCT03652064 | 3 | DaraVRd followed by DaraRd vs. VRd followed by Rd |
395 NDMM for whom ASCT is not planned as initial therapy | MRD negativity rate | 10−5 /NGS | Active not recruiting |
| NCT03617731 | 3 | Isa-RVd vs. RVd for induction, ASCT and Isa-R vs. R for maintenance therapy | 662 NDMM eligible for ASCT | MRD negativity rate after induction, PFS after 2nd randomization | 10−5/NGF | Recruiting |
| NCT03500445 | 2 | Single-arm: DaraKRd as initial therapy | 75 NDMM eligible or not for ASCT | sCR rate, MRD negativity rate | NR/NGS | Recruiting |
| NCT03290950 | 2 | Single-arm: DaraKRd | 41 NDMM | MRD negativity rate | NR/NR | Recruiting |
| NCT02253316 | 2 | Ixa-Rd as consolidation post ASCT + Ixa or R for maintenance | 236 NDMM | MRD negativity rate at d112 post consolidation | NR/NGS (ClonoSEQ assay) | Active, not recruiting |
| NCT03104842 | 2 | Isa-KRd as consolidation and Isa-KR as maintenance | 153 NDMM eligible and not ASCT | MRD negativity rate | NR/NGF | Recruiting |
| NCT03477539 | 2 | Single arm: Dara as consolidation, ASCT, DaraR for maintenance | 50 MM patients eligible for ASCT with any prior induction therapy | MRD negativity rateat d100 post ASCT | NR/MFC | Recruiting |
Dara, Daratumumab; d, Dexamethazone; Elo, Elotuzumab; Isa, Isatuximab; Ixa, Ixazomib; K, Carfilzomib; P:Pomalidomide; R, Lenalidomide; V, Velcade; MM, Multiple Myeloma; sMM, Smoldering MM; NDMM, Newly-diagnosed MM; R/R, Relapsed/Refractory; CAR, Chimeric antigen receptor; BCMA, B-cell maturation antigen; ASCT, Autologous stem-cell transplantation; MRD, Minimal residual disease; NGS, Next-generation sequencing; NGF, Next-generation flow cytometry; MFC, Multicolor flow cytometry; DLT, dose- limiting toxicities; SAEs, Serious adverse events; sCR, Stringent complete response; ORR, Overall response rate; PFS, Progression free survival; OS, qurvival; NR, Not reported.