Version May 2024
| Parameter | Evaluable | Complete response | Improvement | Progression* |
| Plasma VEGF | 2 × ULN | Normal¶ | 50% reduction from baseline¶ | 50% increase from lowest level |
| Hematologic | M-spike 0.5 g/dLΔ, 1.0 g/dL◊§ | Negative serum & urine IFE & bone marrow¶ | 50% reduction of M-spike from baseline¥ | 25% increase from lowest level, which must be >0.5 g/dL |
| PET/CT | At least one lesion with FDG SUVmax‡ | No FDG uptake | 50% reduction in sum of SUVmax‡ | 30% increase of sum of SUVmax‡ from lowest level, which must be at least 4 SUVmax‡ OR appearance of new FDG avid lesion |
| mNIS +7POEMS | All patients | – | ↓15% change from baseline (a minimum of 10 points) | ↑15% change from lowest value (a minimum of 10 points) |
| Ascites/effusion/edema | Present | Absent | Improved by 1 CTCAE grade from baseline | Worsened by 1 CTCAE grade from lowest grade |
| ECHO RVSP | ≥40 mmHg | – | <40 mmHg | – |
| Papilledema | Present | – | Absent | Worsening by 1 CTCAE grade |
| DLCO | <70% predicted | ≥70% predicted | – | Worsening by 1 CTCAE grade |
POEMS: Polyneuropathy, Organomegaly, Endocrinopathy, M protein, Skin changes; DLCO: diffusing capacity of carbon monoxide; ECHO RVSP: echocardiogram right ventricular systolic pressure; IFE: immunofixation; PET/CT: positron emission tomography/computed tomography; mNIS+7: modified neuropathy impairment score + 7 neurophysiologic tests; CTCAE: common terminology criteria for adverse events.
* Any progression event (VEGF, hematologic, or clinical) will be considered progression, assuming change is attributable to disease and not an adverse event. To document progression, option exists for repeating value. If confirmed, progression date is first date of suspected progression.
¶ For VEGF and M-spike and IFE response documentation, blood values need to be repeated for verification.
Δ For VGPR evaluable.
◊ For PR evaluable.
§ Quantitative IgA is acceptable surrogate for M-spike for proteins migrating in the beta region.
¥ VGPR is defined as no measurable monoclonal protein on serum or urine electrophoresis, but positive IFE.
‡ By body weight.آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
