Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study

Table 2 Change in HRQoL as evaluated by a mixed-effects regression model

		Change in FACT-MM total score^a		Change in FACT-G score^a		Change in FACT-MM TOI total score^b		Change in MM domain score^c
	Max N	Coefficient (95% CI)	p-value	Coefficient (95% CI)	p-value	Coefficient (95% CI)	p-value	Coefficient (95% CI)	p-value
Cycle 2	71^d	−3.94 (−8.03 to 0.16)	0.059	−3.87 (−6.66 to −1.08)	0.007	−4.86 (−8.44 to −1.29)	0.008	−0.10 (−2.11 to 1.92)	0.926
Cycle 3	42	−5.17 (−10.10 to −0.25)	0.040	−5.69 (−9.05 to −2.33)	0.001	−4.92 (−9.21 to −0.64)	0.024	0.61 (−1.81 to 3.03)	0.619
Cycle 4	25	−5.47 (−11.38 to 0.45)	0.070	−4.00 (−8.04 to 0.04)	0.052	−5.65 (−10.79 to −0.52)	0.031	−1.35 (−4.28 to 1.58)	0.367
Cycle 5	13	−3.97 (−11.58 to 3.65)	0.307	−3.62 (−8.82 to 1.59)	0.173	−4.60 (−11.22 to 2.03)	0.174	0.21 (−3.43 to 3.85)	0.911
Cycle 6	8^e	−3.54 (−13.59 to 6.51)	0.490	−4.62 (−11.49 to 2.25)	0.187	−3.35 (−12.10 to 5.41)	0.453	2.57 (−1.95 to 7.09)	0.265
End of treatment	39^f	−10.45 (−16.19 to −4.70)	< 0.0001	−8.14 (−11.68 to −4.60)	< 0.001	−9.39 (−14.22 to −4.57)	< 0.001	−1.80 (−4.93 to 1.34)	0.261

AIC Akaike’s Information Criterion, BIC Bayesian Information Criterion, FACT-G Functional Assessment of Cancer Therapy – General, FACT-MM Functional Assessment of Cancer Therapy – Multiple Myeloma, MM multiple myeloma, TOI Trial Outcomes Index, CI confidence interval
^a Adjusted for baseline score, race, sex, and years since diagnosis
^b Adjusted for baseline score, race, sex, and number of prior regimens
^c Adjusted for baseline score, race, sex, ECOG performance score, and number of prior regimens
^d n = 70 for FACT-MM total score and FACT-G
^e n = 7 for FACT-MM total score, FACT-G, and FACT-TOI
^f n = 38 for FACT-MM total score, FACT-G, and FACT-TOI

ISSN: 1471-2407