Table 1 Clinical assessment, imaging, and laboratory studies included for participants in the different study arms of the iStopMM study as per protocol.
Test | Arm 2–low risk and LC-MGUS | Arm 2–non-low risk | Arm 3–All | SMM and SWM | MM and WM |
|---|---|---|---|---|---|
Physical exama | First visit | First visit | Each visit | Each visit | At diagnosis |
Blood sampling | |||||
SPEP FLC assay | Each visit | Each visit | Each visit | Each visit | At diagnosis |
CBC | First visit | Each visit | Each visit | Each visit | At diagnosis |
Total calcium Albumin Creatinine | First visit | First visit | Each visit | Each visit | At diagnosis |
CRP LDH ß2M | – | – | Each visit | Each visit | At diagnosis |
TnT pro-BNP | – | – | Annually | Annually | At diagnosis |
Bone marrow | |||||
Smear Biopsy | As clinically indicated | 0 months Except if LC | 0 and 60 months | Annually | At diagnosis |
Urine | |||||
Protein dipstick | First visit | First visit | – | – | – |
UPEP | If positive dipstick or if previously abnormal | If positive dipstick or if previously abnormal | – | – | – |
Albumin/creatinine ratio | – | – | Annually | Annually | At diagnosis |
ECG | – | – | Annually | Annually | At diagnosis |
Imaging | |||||
WB-LDCT | – | – | 0 and 60 months in LC- and non-IgM | Annually in LC- and non-IgM | At diagnosis of MM |
Plain X-ray of bones | As clinically indicated | First visit in LC- and non-IgM | – | – | – |
CT abdomen | – | First visit to IgM | 0 and 60 months in IgM | Annually in IgM | At diagnosis of WM |
MRI of bones | – | – | – | As clinically indicated | – |
Follow-up | Every 2–3 years | Annual | Annual | Every 4–6 months | Single-visit |
