Clinical outcomes with fixed-duration therapy (UK real-world data) compared with continuous lenalidomide and low-dose dexamethasone therapy (FIRST trial; MM-020) for transplant-ineligible patients with newly-diagnosed multiple myeloma

Figures & data

Table 1. Baseline patient demographic and clinical characteristics.

Characteristic	FDT cohort (n = 223)	Rd continuous cohort (n = 254)
Male, n (%)	126 (57)	149 (59)
Age, median (IQR), years	75 (70–81)	76 (69–79)
≤75 years, n (%)	110 (49)	125 (49)
>75 years, n (%)	113 (51)	129 (51)
ISS stage, n (%)
I or II	93 (42)	105 (41)
III	130 (58)	149 (59)
Serum creatinine ≥140 μmol/L,^a n (%)	62 (29)	56 (22)
Frontline therapy, n (%)
Thalidomide-based	148 (66)	–
Proteasome inhibitor-based^b	53 (24)	–
Lenalidomide-based	–	254 (100)
Alkylator-based	22 (10)	–
Frontline combination regimen, n (%)
Doublet	61 (27)	254 (100)
Triplet	162 (73)	–
Cycles of frontline therapy^c
Median (range)	6 (1–28)	19 (1–91)
1–5 cycles, n (%)	106 (48)	54 (21)
6–10 cycles, n (%)	109 (50)	34 (13)
>10 cycles, n (%)	<5 (≤2)	165 (65)
Duration of frontline therapy, median (range), months^c	4.6 (0.2–25.6)	18.0 (0.1–84.3)
Isotype,^d n (%)
IgG	110 (49)	153 (60)
Kappa light chain/free kappa	36 (16)	–
Lambda light chain/free lambda	30 (13)	–
IgA	41 (18)	71 (28)
IgA/IgG	<5 (≤2)	<5 (≤2)
IgM	<5 (≤2)	<5 (≤2)
IgD	<5 (≤2)	<5 (≤2)
Not available	<5 (≤2)	26 (10)

Where n = 0–4, numbers have been suppressed and reported as <5, to preserve confidentiality.

^aData available for 217 patients in the FDT cohort.

^b52 patients received bortezomib and 1 patient received carfilzomib.

^cData available for 219 patients in the FDT cohort and 253 patients in the Rd continuous cohort.

^dPercentages may not total 100% due to rounding.

FDT: fixed-duration therapy; Ig: immunoglobulin; IQR: interquartile range; ISS: International Staging System; Rd: lenalidomide and low-dose dexamethasone.

Figure 1. OS (A), PFS (B), and TTNT (C) were all significantly shorter in the real-world FDT cohort than in the MM-020 trial-derived Rd continuous cohort (Kaplan–Meier analyses). Time-dependent variables were compared between the FDT and Rd continuous cohorts using unstratified log-rank tests and Cox regression analyses, with proportionality of hazards evaluated using Schoenfeld residuals. ^aOne patient died before the start of the treatment. ^bDue to lack of progression-onset information, patients were censored at time 0; n = 3 in the FDT cohort, and n = 7 in the Rd continuous cohort. CI: confidence interval; FDT: fixed-duration therapy; HR: hazard ratio; OS: overall survival; PFS: progression-free survival; Rd: lenalidomide and low-dose dexamethasone; TTNT: time to next treatment.