Salient features of the GEM-CESAR and ASCENT trials testing aggressive intervention in high-risk SMM
| . | GEM-CESAR . | ASCENT . |
|---|---|---|
| Inclusion criteria | High risk defined by the Spanish/PETHEMA model | High risk defined by the Mayo 20/2/20 model or IMWG risk-stratification score ≥ 9 |
| Mandatory MRI at screening | No∗ | No |
| Treatment schema | KRD × 4 → HDM-AHCT → KRD × 2 → R maintenance for 2 y | Dara-KRD × 24 cycles |
| Primary end point | Sustained MRD-negativity at 4 and 5 y by MFC (10−5) | sCR rate |
| . | GEM-CESAR . | ASCENT . |
|---|---|---|
| Inclusion criteria | High risk defined by the Spanish/PETHEMA model | High risk defined by the Mayo 20/2/20 model or IMWG risk-stratification score ≥ 9 |
| Mandatory MRI at screening | No∗ | No |
| Treatment schema | KRD × 4 → HDM-AHCT → KRD × 2 → R maintenance for 2 y | Dara-KRD × 24 cycles |
| Primary end point | Sustained MRD-negativity at 4 and 5 y by MFC (10−5) | sCR rate |
Dara-KRD, daratumumab-carfilzomib-lenalidomide-dexamethasone; MFC, multiparameter flow cytometry; R, lenalidomide.
Based on the presentation at the 2022 Annual Meeting of the American Society of Hematology,4 bone disease was ruled out by low-dose whole-body computed tomography or positron emission tomography/computed tomography. The complete protocol is not yet available.