A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the GeminiS study

Figures & data

Figure 1. Patient flow diagram.

Table 1. Patient characteristics and type of therapy at relapse.

	Group A		Group B
	N		N
Age, years, median [IQR]	108	74.0 [69.0-79.0]	63	71–0 [64.0-76.0]
≤ 75 years n (%)		64 (59.3)		47 (74.6)
Sex, male, n (%)	108	57 (52.8)	63	39 (61.9)
Weight, kg, median [IQR]	108	70.0 [62.0-79.0]	63	72.5 [64.0-81.0]
Height, cm, median [IQR]	108	164.0 [155.0-170.0]	63	166.0 [156.0-174.0]
Comorbidities, n (%)	106		59
Cardiopathy		35 (33.0)		15 (25.4)
Pneumopathy		11 (10.4)		2 (3.4)
Peripheral neuropathy		9 (8.5)		8 (13.6)
Renal failure		16 (15.1)		10 (16.9)
Type of progression, n (%)	117		63
Biologic		48 (41)		26 (41)
Symptomatic		69 (59)		37 (59)
yeloma type, n (%)^a	108		58
IgG		61 (56)		27 (46)
IgA		24 (22)		19 (33)
Light chains		19 (18)		8 (14)
Other		4 (4)		4 (7)
Creatinine clearance, n (%)	117		63
<30 mL/min		13 (11)		3 (5)
30–60 mL/min		31 (27)		15 (24)
>60 mL/min		53 (45)		29 (46)
Not available		20 (17)		16 (25)
FISH cytogenetic profile, n (%)^b	70		44
High risk^e		15 (21)		11 (25)
Extended high risk^f		27 (39)		16 (36)
Disease staging ISS^c, n (%)	74		45
ISS I		23 (31)		14 (31)
ISS II		24 (32)		20 (45)
ISS III		27 (37)		11 (24)
Disease staging R-ISS^d, n (%)	41		25
R-ISS I		16 (39)		5 (20)
R-ISS II		17 (42)		16 (64)
R-ISS III		8 (19)		4 (16)
Treatment of relapse, n (%)	117		63
Rd		42 (36)		–
KRd		32 (27)		–
V-based regimen		19 (16)		–
Other		12 (10)		–
Pom-based regimen		8 (7)		–
Kd		4 (3)		–
DRd		–		25 (40)
DVd		–		38 (60)

^a 11 patients not available.

^b 66 patients not available.

^c 61 patients not available/not reported.

^d 114 patients not available/not reported.

^e High-risk cytogenetics: presence of t(4;14), t(14;16), and/or De17p13(P53).

^f Extended high-risk cytogenetics: presence of t(4;14), t(14;16), and/or De17p13(P53), plus Add(1q).

DRd: daratumumab-lenalidomide-dexamethasone; DVd: daratumumab-bortezomib-dexamethasone; FISH: fluorescence in situ hybridization; IQR: interquartile range; ISS: International Staging System; Kd: carfilzomib-dexamethasone; KRd: carfilzomib-lenalidomide-dexamethasone; Pom: pomalidomide; Rd: lenalidomide-low dose dexamethasone; R-ISS: Revised International Staging System; V: bortezomib.

Figure 2. Progression-free survival (PFS).

Table 2. Best response to relapse therapy per treatment group.

Type of response	Group A (N = 108)		Group B (N = 63)
	N	%	N	%
Overall response rate	80	74.1	48	76.2
Strict complete response	10	9.2 14.8 26.9 23.1 0.9 7.4 7.9 12.3	6	9.5
Complete response	16		12	19
Very good partial response	29		17	27
Partial response	25		13	20.1
Minimal response	1		0	0.0
Stable disease	8		5	8
Disease progression	5		1	1.6
Not available	14		9	14.3

Table 3. Time to response (months).

Type of response	Group A				Group B
	1st relapse		2nd relapse		1st relapse		2nd relapse
	Median	IQR	Median	IQR	Median	IQR	Median	IQR
First response	2.0	0.7-18.1	2.5	0.6-18.0	1.2	0.3-6,5	1.0	0.2-6.9
Best response	4.9	0.8-18.1	7.4	0.9-18.0	3.6	0.7-10.3	5.4	0.2-7.4

IQR: interquartile range.

Table 4. Severe adverse events reported during the prospective phase of the study.

Adverse events grade 3 + 4^a	Prospective phase
	Group A N = 74		Group B N = 39
	N	%	N	%
Hematological
Anemia	1	1.4	4	10.3
Neutropenia	7	9.5	3	7.7
Thrombocytopenia	4	5.4	1	2.6
Hematotoxicity	0	0.0	2	5.1
Pancytopenia	1	1.4	0	0.0
Non-hematological
Asthenia	0	0.0	2	5.1
Testicular edema	0	0.0	1	2.6
Bacteremia caused by Escherichia coli	0	0.0	1	2.6
Hip fracture	0	0.0	1	2.6
Pneumonia	0	0.0	1	2.6
Peripheral neuropathy	1	1.4	0	0.0
Deterioration of the general state	1	1.4	0	0.0
Gastroenteritis	1	1.4	0	0.0
Lower respiratory tract infection	1	1.4	0	0.0
Respiratory tract infection	1	1.4	0	0.0
Urinary tract infection	1	1.4	0	0.0
Illium fracture	1	1.4	0	0.0
Tachycardia	1	1.4	0	0.0

^a Grade 3 or 4 adverse events that were reported in at least one patient in either treatment group are listed.

Data availability statement

Data is available from corresponding author upon reasonable request. The data will be provided after its deidentification in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.