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 |
Note that additional sampling and imaging were permitted as clinically indicated and decided at regularly scheduled clinical decision meetings.
SMM smoldering multiple myeloma, SWM smoldering Waldenströms macroglobulinemia, MM multiple myeloma, WM Waldenströms macroglobulinemia, SPEP serum protein electrophoresis, FLC free light chains, CBC complete blood count, CRP C-reactive protein, LDH Lactate dehydrogenase, ß2M ß-2-microglobulin, TnT Troponin T, pro-BPN pro-Brain natriuretic peptide, UPEP Urine protein electrophoresis, ECG electrocardiogram, WB-LDCT whole-body low-dose computerized tomography, CT Computerized tomography, MRI magnetic resonance imaging, LC Light chain.