Table 1 Characteristics of the included studies and patient populations.
Author (year) | Tx | Control | Treatment duration | sMM risk category | sMM risk category definition | Progression criteria | Primary endpoint | Assessment intervals | N (experimental) | N (control) | Follow-up (median) |
|---|---|---|---|---|---|---|---|---|---|---|---|
Dimopoulos et al. [9] | D | Obs | Fixed duration 3 y | High-risk | BMPC > = 10% and at least one of: serum M-protein level >= 30 g/L, IgA isotype, immunoparesis in two uninvolved IgS, serum involved to uninvolved FLC ratio 8 to <100, BMPC 50% to < 60% | 2014 IMWG SLiM–CRAB [1] | PFS | Disease evaluation every 12 weeks / Imaging at baseline and every year (CT or PET/CT and MRI) | 194 | 196 | 65.2mo |
Rd | Obs | Fixed duration 2 y | High-risk | BMPC > = 10% and [IgG > =3 g/dl, or IgA > =2 g/dl, or BJ proteinuria >1 g/24 h]; or only one of the previous plus >=95% phenotypically aberrant BMPC with immunoparesis | 2006 IMWG CRAB [20] | TTP | Disease evaluation every 4 weeks / Skeletal survey at baseline and in case of symptoms | 57 | 62 | 150.0mo | |
Lonial et al. [10] | R | Obs | Until disease progression/toxicity/withdrawal | Intermediate or High-risk | BMPC > = 10% and abnormal FLC ratio <0.26 or >1.65 | 2006 IMWG biochemical progression with CRAB (ASH/FDA 2008) [21] | PFS | Disease evaluation every 12 weeks / Skeletal survey and MRI of the spine and pelvis at baseline | 90 | 92 | 35.0mo |
Brighton et al. [17] | Sx | Plb | Until disease progression/toxicity/withdrawal | High-risk | BMPC > = 10% and either serum M-protein >=3 g/dL, or abnormal FLC ratio (<0.126 or >8) and serum M-protein 1 to <3 g/dL | 2006 IMWG CRAB [20] | 1 y PFS rate | Disease evaluation every 4 weeks / Imaging not reported | 43 | 42 | 29.2mo |
Witzig et al. [20] | T-ZA | ZA | Until disease progression/toxicity/withdrawal | All sMM | BMPC > = 10% and serum M-protein ≥1 g/dl or urine M-protein >200 mg/24 h. | 2006 IMWG CRAB or biochemical progression [20] | TTP | Disease evaluation every 12 weeks / Skeletal survey at baseline | 35 | 33 | 70.8mo |
