Table 1 Key phase III trials in MM reporting on MRD negativity in transplant ineligible/deferred older adults.
From: MRD negativity: considerations for older adults with multiple myeloma
Study | N | Treatment | MRD technique | Results |
|---|---|---|---|---|
Published studies | ||||
Pethema/GEM2010MAS65 [6] NDMM | 163 | 1. VMP × 9 followed by Rd 2. Alt VMP/Rd × 18 | Flow, 10−5 | MRD negativity rates of 20% (arm 1) and 24% (arm 2) MRD-negativity was associated with a prolonged TTP (median not reached (NR) vs 35 months; P = 0.001) and OS (100% vs 72% at 3 years; P = 0.02) compared to MRD-positive patients |
Myeloma XI trial [7] NDMM | 297 | 1. CTDa 2. RCDa | Flow, 10−4 | MRD negativity rates of 10.8% (arm 1) and 16.0% (arm 2) MRD negativity was associated with improved PFS (34 months vs 18 months; P < 0.0001, HR 0.44). |
MAIA [2] NDMM | 737 | 1. DRd 2. Rd | NGS, clonoSEQ assay, 10−5 | MRD negativity: 28.8% (arm 1) and 9.2 % (arm 2) MRD-negative patients had improved PFS compared with MRD-positive patients (MAIA: HR, 0.15 [95% CI, 0.09–0.26] |
ALCYONE [2] NDMM | 706 | 1. Dara-VMP 2. VMP | NGS, clonoSEQ assay, 10−5 | MRD negativity: 26.9% (arm 1) and 7.0% (arm 2) HR, 0.21 [95% CI, 0.15–0.30]; P < 0.0001 |
IKEMA [8] R/R | 86 (age ≥70 years) | 1. IsaKd 2. Kd | NGS, clonoSEQ assay, 10−5 | MRD negativity: 23.1% (arm 1) and 11.8% (arm 2) |
CLARION [9] NDMM | 955 | 1. VMP 2. KMP | Flow, 10−6 | MRD negativity: 15.5% (arm 1) and were 15.7% (arm 2) |
GEM2005MAS65 [10] NDMM | 260 | 1. VMP 2. VTD | Flow, 10−4 | PFS: Arm 1 (MRD negative NR, MRD positive 28 months); Arm 2 (MRD negative 53 months, MRD positive 27 months); P = 0.01 |
ENDURANCE [11] NDMM | 1087 | 1. VRd 2. KRd | Flow, | MRD negativity: 7.0% (arm 1) and were 10.0% (arm 2) |
Trials in progress | ||||
MagnetisMM- 6 (NCT05623020) NDMM | 676 | 1. ElraRd 2. DRd | NGS, clonoSEQ assay, 10−5 | Primary end point: MRD negativity at 12 months, PFS |
MajesTEC 7 (NCT05552222) NDMM | 1068 | 1. TecDRd 2. DRd | NGS, clonoSEQ assay, 10−5 | Primary end points: PFS, MRD negativity at 12 months + CR |
CEPHEUS (NCT04751877) NDMM | 395 | 1. DRVd 2. RVd | NGS, clonoSEQ assay, 10−5 | Primary end point: % of participants with negative MRD status |
IMROZ (NCT03319667) NDMM | 475 | 1. IsaRVd 2. RVd | NGS, clonoSEQ assay, 10−5 | Primary end point: PFS Secondary end point: MRD negativity rate, sustained MRD negativity |
CARTITUDE 5 (NCT04923893) NDMM | 650 | 1. RVD-Ciltacel 2. RVD | NGS, clonoSEQ assay, 10−5 | Primary end point: PFS Secondary endpoint: MRD negativity at 12 months + CR |
