Table 5.
The REMIX study and other IXA-Rd papers
| Reference | Name of the study | Design | Country | Number of patients | Patient characteristics | Effectiveness | Safety | Subgroups of interest |
|---|---|---|---|---|---|---|---|---|
| Moreau P et al. [4] / Richardson et al. [26] | TOURMALINE-MM1 | Clinical trial | 26 countries | 722 patients (360 in IXA-Rd group) |
Median age: 66 years, % > 65: 53% L2 (62%), L3 (27%), L4 (11%) Previously exposed to R: 12% |
ORR: 78% ≥ VGPR: 48% mPFS: 20.6 months mPFS > 75 years: 18.5 mPFS ISS III: 18.4 months mPFS high-risk cytogenetics: 21.4 months mOS: 53.6 months |
Discontinuation due to toxicity: 17% | Age, ISS stage, cytogenetic risk, number of prior therapies, prior exposition to IP and IMID, refractory to last therapy, relapsed or refractory |
| Macro M et al. 2023 (present study) | REMIX study | Real-world prospective study | France | 376 patients across 60 sites |
Median age: 71 years, %80 + : 18% L2 (60%), L3 (18%), L4 + (22%) Previously exposed to R: 39.2% |
ORR: 73% ≥ VGPR: 45% mPFS: 19.1 months L2 and L3: 22 months vs L4 + : 6 months ≥ 80y: 17 months vs 19 months in < 80y frail: 15 months vs 22 months in non-frail mOS not reached |
Discontinuation due to toxicity: 21% | Age, frailty, line of treatment, renal failure, comorbidities, previous ASCT, prior exposure to R |
| Varga G et al. [21] | - | Real-world retrospective study | Hungary | 77 patients treated at 7 centers |
Median age: 66 years L2 (27%), L3 (35%), L4 (39%) |
ORR: 67% ≥ VGPR: 23% mPFS: 11.4 months mPFS not reached in L2, was 10 months in L3 and 8.8 months in L4 No difference according ISS and cytogenetic profile |
No permanent drug interruptions due to AEs |
ISS classification Cytogenetic profile |
| Cohen YC et al. [22] | - | Real-world retrospective study | Israel | 78 patients across 7 sites |
Median age: 68 years L2 (64%), L3 (19%), L4 + (17%) Previously exposed to R: 26% |
ORR: 88% ≥ VGPR: 45% mPFS: 24 months mPFS not reached vs 20.2 months for age ≤ 65 vs > 65, respectively mOS not reached |
Discontinuation due to toxicity: 14% |
Age (≤ 65) No effect on PFS was found for gender, BSA, ixazomib line number, diagnosis paraprotein and involved light chain, cytogenetic risk, ISS, presence of CRAB or EMD levels above ULN, prior drug exposure (IMiDs, PIs), and prior ASCT |
| Terpos E et al. [23] | - | Real-world retrospective study | Greece, the UK, and the Czech Republic | 155 patients who received IXA via early access programs |
Median age: 68 years L2 (51%), L3 (28%), L4 + (21%) Previously exposed to R: 17% |
ORR: 74% (76.5% in L2, 71.2% in L3 +) ≥ VGPR: 35% mPFS: 27.6 months L2: 27.6 months L3 + : 19.9 months prior exposure to R: mPFS 4.8 months (n = 26) no prior exposure to R: 27.6 (n = 129) |
Discontinuation due to adverse events/toxicity: 9% |
Gender Prior ASCT Length of ixazomib exposure Prior IMID exposure |
| Minarik J et al. [24] | - | Real-world prospective study | The Czech Republic | 127 patients |
Median age: 66 years L2 (58%), L3 (24%), L4 + (19%) Previously exposed to R: 17% (6% refractory) |
ORR: 73% ≥ VGPR: 33.3% mPFS: 17.5 months L2: 32.8 months L3: 23.1 months L4: 9.7 months L5 + : 5 months > 75 years: 11.1 months mOS: 36.6 months |
Discontinuation due to toxicity: 3.1% |
Age, ISS stage, ASCT, cytogenetics, maximal treatment response, and pretreatment |
| Hajek R et al. [25] | - | Real-world study | 13 countries (INSIGHT MM and the Czech RMG) | 263 patients |
Median age: 68 years with 15% > 75 years L2 (44%), L3 (35%), L4 + (21%) Previously exposed to R: 27% (7% refractory) |
ORR: 73% ≥ VGPR: 37% mPFS: 21 months L2: 26 months L3: 24 months L4: 14 months |
Discontinuation due to AEs: 32% | Line of treatment |