Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma

Figures & data

Table 1. Baseline demographics and clinical characteristics of HRQoL-evaluable patients.

Characteristic	RVd-alone (n = 309)		RVd-ASCT (n = 295)	Overall (N = 604)
Age, years, mean (SD)	56.5 (6.72)		56.8 (7.23)	56.7 (6.97)
Age, years, n (%)
≤55	115 (37.2)		91 (30.8)	206 (34.1)
56–59	60 (19.4)		65 (22.0)	125 (20.7)
≥60	134 (43.4)		139 (47.1)	273 (45.2)
Male, n (%)	183 (59.2)		179 (60.7)	362 (59.9)
ECOG PS, n (%)
0	151 (48.9)		138 (46.8)	289 (47.8)
1	128 (41.4)		130 (44.1)	258 (42.7)
2	29 (9.4)		21 (7.1)	50 (8.3)
3	1 (0.3)		5 (1.7)	6 (1.0)
4	0		1 (0.3)	1 (0.2)
β2-Microglobulin, n (%)
<3.5 mg/L	151 (48.9)		149 (50.5)	300 (49.7)
3.5–5.5 mg/L	105 (34.0)		96 (32.5)	201 (33.3)
>5.5 mg/L	53 (17.2)		50 (16.9)	103 (17.1)
ISS stage, n (%)
1	106 (34.3)		102 (34.6)	208 (34.4)
2	149 (48.2)		142 (48.1)	291 (48.2)
3	54 (17.5)		51 (17.3)	105 (17.4)
Cytogenetic abnormalities, n (%)^a
Standard	186 (60.2)		183 (62.0)	369 (61.1)
High risk	38 (12.3)		36 (12.2)	74 (12.3)
FISH failures	85 (27.5)		76 (25.8)	161 (26.7)

ASCT: autologous stem cell transplantation; ECOG PS: Eastern Cooperative Oncology Group performance status; FISH: fluorescent in situ hybridization; HRQoL: health-related quality of life; ISS: International Staging System; RVd: lenalidomide, bortezomib, and dexamethasone; SD: standard deviation.

^aHigh risk is defined as the presence of del(17p), or t(4:14), or t(14;16).

Table 2. Mean (SD) HRQoL scores at baseline for the HRQoL-evaluable population.

	RVd-alone	RVd-ASCT	Overal	General population^a
HRQoL domain	(n = 309)	(n = 295)	(N = 604)	(N = 11,343)
QLQ-C30
Global QoL^b	58.3 (23.6)	54.7 (23.6)	56.6 (23.7)	65.5
Physical functioning^b	69.7 (27.0)	69.1 (26.7)	69.4 (26.8)	84.9
Role functioning^b	51.0 (37.2)	52.7 (37.6)	51.9 (37.4)	84.2
Fatigue	40.2 (27.6)	42.9 (28.6)	41.5 (28.1)	27.2
Pain	46.0 (34.7)	48.0 (33.8)	47.0 (34.3)	24.0
QLQ-MY20
Disease symptoms	28.1 (21.0)	30.6 (22.4)	29.4 (21.7)	NA

ASCT: autologous stem cell transplantation; NA: not available; QLQ-C30: Quality of Life Questionnaire Core-30; QLQ-MY20: Quality of Life Questionnaire for Patients with Multiple Myeloma; QoL: quality of life; RVd: lenalidomide, bortezomib, and dexamethasone; SD: standard deviation.

^aNolte et al. (2019) [19]. These values are weighted, based on age and gender matching with the IFM 2009 study population; SD values are not available.

^bA high score for the domains of global QoL, physical functioning, and role functioning represents a high or healthy level of functioning. For the remaining domains, a high score for a symptom scale represents a high level of symptomatology or problems.

Figure 1. Mean observed scores for the QLQ-C30 domains in the IFM 2009 trial compared with the general population of: global QoL (a); physical functioning (b); and role functioning (c).^a ASCT: autologous stem cell transplantation; C: cycle; D: day; EOT: end of treatment; FU: follow-up; IFM: Intergroupe Francophone du Myelome; M: maintenance; PA: post-autograft; PreMob: premobilization; QLQ-C30: Quality of Life Questionnaire Core-30; QoL: quality of life; RVd: lenalidomide, bortezomib, and dexamethasone; SD: standard deviation. ^aEnd of induction is end of cycle 3/prior to PreMob; follow-up visit 1 is 2 years after initial dosing; follow-up visit 2 is 3 years after initial dosing. ^bGeneral population (N = 11,343). Mean global QoL value for general population is 65.5 (weighted score). Reference values for general population were used as a benchmark to help interpret findings [19]. ^cGeneral population (N = 11,343). Mean value for general population is 84.9 (weighted score). ^dGeneral population (N = 11,343). Mean value for general population is 84.2 (weighted score).

Table 3. MMRM analyses for LS mean changes from baseline in HRQoL.

Scales/domain	RVd-alone		RVd-ASCT
	Mean change (95% CI)	p value	Mean change (95% CI)	p value
QLQ-C30
Global QoL
Overall	8.7 (6.9, 10.6)	<.0001	7.7 (5.8, 9.6)	<.0001
Week 6^a (PreMob)	5.0 (3.1, 7.0)	<.0001	3.3 (1.2, 5.3)	.0017
Week 21 (C8D1)	6.4 (4.6, 8.3)	<.0001	4.9 (3.0, 6.9)	<.0001
Week 72 (EOT)	11.3 (9.3, 13.2)^b	<.0001	10.7 (8.7, 12.6)^b	<.0001
Physical functioning
Overall	9.5 (7.8, 11.2)	<.0001	7.9 (6.1, 9.6)	<.0001
Week 6^a (PreMob)	6.1 (4.3, 8.0)	<.0001	3.1 (1.2, 5.1)	.0019
Week 21 (C8D1)	7.4 (5.6, 9.2)	<.0001	4.9 (3.1, 6.7)	<.0001
Week 72 (EOT)	11.7 (10.0, 13.5)^b	<.0001	11.0 (9.2, 12.8)^b	<.0001
Role functioning
Overall	18.1 (15.5, 20.6)	<.0001	15.0 (12.3, 17.7)	<.0001
Week 6^a (PreMob)	12.7 (9.8, 15.6)^b	<.0001	7.3 (4.2, 10.3)	<.0001
Week 21 (C8D1)	14.8 (12.1, 17.5)^b	<.0001	10.2 (7.4, 13.1)^b	<.0001
Week 72 (EOT)	21.9 (19.3, 24.6)^b	<.0001	20.3 (17.6, 23.0)^b	<.0001
Fatigue
Overall	−6.8 (−9.0, −4.6)	<.0001	−3.9 (−6.2, −1.7)	.0007
Week 6^a (PreMob)	−2.7 (−5.1, −0.3)	.0275	1.9 (−0.7, 4.4)	.1489
Week 21 (C8D1)	−4.3 (−6.6, −2.0)	.0003	−0.3 (−2.7, 2.0)	.7803
Week 72 (EOT)	−9.6 (−11.9, −7.3)	<.0001	−7.8 (−10.1, −5.5)	<.0001
Pain
Overall	−15.2 (−17.5, −121.8)	<.0001	−13.7 (−16.1, −11.3)	<.0001
Week 6^a (PreMob)	−13.5 (−16.0, −10.9)^b	<.0001	−9.9 (−12.6, −7.3)	<.0001
Week 21 (C8D1)	−14.2 (−16.6, −11.8)^b	<.0001	−11.4 (−13.9, −8.9)^b	<.0001
Week 72 (EOT)	−16.5 (−19.0, −14.0)^b	<.0001	−16.3 (−18.9, −13.8)^b	<.0001
QLQ-MY20
Disease symptoms
Overall	−9.6 (−11.1, −8.0)	<.0001	−8.9 (−10.5, −7.4)	<.0001
Week 6^a (PreMob)	−10.5 (−12.1, −9.0)^b	<.0001	−8.8 (−10.4, −7.2)	<.0001
Week 21 (C8D1)	−10.2 (−11.7, −8.7)^b	<.0001	−8.9 (−10.5, −7.3)	<.0001
Week 72 (EOT)	−9.2 (−10.8, −7.5)	<.0001	−9.2 (−10.9, −7.5)	<.0001
Side effects
Overall	1.0 (−0.5, 2.4)	.1874	3.6 (2.1, 5.1)	<.0001
Week 6^a (PreMob)	3.6 (2.1, 5.2)	<.0001	6.3 (4.7, 7.9)	<.0001
Week 21 (C8D1)	2.6 (1.1, 4.1)	.0005	5.3 (3.7, 6.8)	<.0001
Week 72 (EOT)	−0.9 (−2.4, 0.6)	.2486	1.7 (0.2, 3.2)	.0295

ASCT: autologous stem cell transplantation; C8D1: day 1 of cycle 8; CI: confidence interval; EOT: end of treatment; HRQoL: health-related quality of life; LS: least squares; MMRM: mixed model repeated measures; PreMob: premobilization; QLQ-C30: Quality of Life Questionnaire Core-30; QLQ-MY20: Quality of Life Questionnaire for Patients with Multiple Myeloma; QoL: quality of life; RVd: lenalidomide, bortezomib, and dexamethasone.

^aWeek 6 is end of cycle 3/prior to PreMob and is defined as end of induction period.

^bClinically meaningful, based on a cutoff threshold of a ≥ 10 point change.

Figure 2. Mean changes from baseline in the IFM 2009 trial for: the fatigue domain of QLQ-C30 (a); and the pain domain of QLQ-C30 in the IFM 2009 trial (b).^a ASCT: autologous stem cell transplantation; C: cycle; CI: confidence interval; D: day; FU: follow-up; IFM: Intergroupe Francophone du Myelome; LS: least squares; M: maintenance; MID: minimally important difference; PA: post-autograft; PreMob: premobilization; QLQ-C30: Quality of Life Questionnaire Core-30; RVd: lenalidomide, bortezomib, and dexamethasone. ^aEnd of induction is end of cycle 3/prior to PreMob; follow-up visit 1 is 2 years after initial dosing; follow-up visit 2 is 3 years after initial dosing. *Significance between the groups at p < .05 based on a two-sample t-test. A positive value indicates improvement from baseline and vice versa.

Nolte S, Liegl G, Petersen MA, et al. General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States. Eur J Cancer. 2019;107:153–163.

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Data availability statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.