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DARZALEX FASPRO®

(daratumumab and hyaluronidase-fihj)

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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Medical Information

DARZALEX FASPRO - Minimal Residual Disease in Clinical Trials

Last Updated: 06/03/2026

SUMMARY

  • Johnson & Johnson does not recommend the use of DARZALEX FASPRO in a manner that is inconsistent with the approved labeling.
  • CEPHEUS is a phase 3 study evaluating the efficacy and safety of DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) or bortezomib, lenalidomide, and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma (NDMM) who are transplant ineligible (TIE) or for whom transplant is not planned as initial therapy (transplant deferred).1
    • Usmani et al (2026)2 presented the final efficacy and safety results of the TIE population of the CEPHEUS study at a median follow-up of 76 months. Overall minimal residual disease (MRD) negativity (10-5) in patients with complete response or better (≥CR) was achieved in 61.1% of patients in the D-VRd arm vs 40.0% of patients in the VRd arm (odds ratio [OR], 2.35; 95% confidence interval [CI], 1.47-3.77). Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 93.8% of patients in the D-VRd arm vs 88.7% in the VRd arm.
    • Zweegman et al (2024)3 presented an expanded analysis of MRD outcomes from the CEPHEUS study in patients with NDMM who were ineligible for a stem cell transplant (SCT) or transplant deferred. The addition of DARZALEX FASPRO to VRd improved cumulative MRD-negativity rates (both 10-5 and 10-6 sensitivities) vs VRd alone at all prespecified timepoints. At 54 months, among patients who achieved both MRD-negativity (10-6) and ≥CR with D-VRd, >85% were alive and progression free. Analyses of MRD-negativity (with ≥CR) rates in D-VRd vs VRd were generally consistent across prespecified subgroups.
  • PERSEUS is a phase 3 study evaluating the efficacy and safety D-VRd vs VRd induction and consolidation followed by maintenance with lenalidomide and daratumumab (D-R) in D-VRd group or lenalidomide (R) in VRd group in patients with NDMM eligible for autologous stem cell transplant (ASCT).4
    • Sonneveld et al (2023)4 reported efficacy and safety results from the PERSEUS study evaluating D-VRd vs VRd in patients with NDMM eligible for ASCT. At a median follow-up duration of 47.5 months (range, 0-54.4), overall MRD-negativity of 75.2% vs 47.5% (P<0.0001) was higher with D-VRd vs VRd cohort.
    • Moreau et al (2025)5 presented findings from the phase 3 PERSEUS study, highlighting the impact of sustained MRD-negativity on PFS and the incidence of functionally high-risk disease. D-VRd vs VRd more than doubled the rates of sustained MRD-negativity ≥CR (10-5) at ≥12 months (64.8% vs 29.7%; OR, 4.42; 95% CI, 3.22-6.08; P<0.0001) and ≥24 months (55.8% vs 22.6%; OR, 4.36; 95% CI, 3.15-6.05; P<0.0001), respectively. D-VRd was associated with higher rates of sustained MRD negativity (10‒5) ≥CR when compared to VRd across subgroups.
  • AURIGA is a phase 3 study evaluating the conversion rate to MRD-negativity after maintenance treatment D-R vs R alone in patients with NDMM who are anti-cluster of differentiation (CD) 38 naïve, have a very good partial response or better (≥VGPR), and are MRD-positive following ASCT after standard-of-care induction/consolidation.6,7
    • Anderson et al (2025)8 presented updated efficacy and safety results from the phase 3 AURIGA study at 24 months from the start of maintenance therapy, with a median follow-up of 40.3 months. The MRD-negativity (10-5) conversion rate was significantly higher for D-R vs R (60.6% vs 28.7%; OR, 3.92; 95% CI, 2.16-7.14; P<0.0001). Similarly, the MRD-negativity (10-6) conversion rate was higher with D-R vs R (36.4% vs 13.9%; OR, 3.59; 95% CI, 1.78-7.23; P=0.0003). No new safety concerns were identified with the addition of DARZALEX FASPRO to R maintenance.
    • Chung et al (2025)9 presented an analysis of MRD dynamics in post-transplant patients with NDMM from the AURIGA study at a median follow up of 40.3 months. At the median follow up, sustained MRD negativity for ≥12 months was more frequent with D-R vs R alone (29.3% vs 7.9% [10-5 sensitivity] and 19.2% vs 2.0% [10-6 sensitivity]). D-R was associated with lower MRD-positive recurrence at 10-6 sensitivity and fewer PFS events among patients achieving MRD negativity compared with R alone.
  • APOLLO is a phase 3 study evaluating the safety and efficacy of DARZALEX FASPRO + pomalidomide and dexamethasone (D-Pd) vs pomalidomide and dexamethasone (Pd) in patients with relapsed refractory multiple myeloma (RRMM).
    • Dimopoulos et al (2021)10 reported the primary analysis of this study with a median follow-up of 16.9 months. MRD-negativity rate was 9% in patients treated with D-Pd vs 2% with Pd (OR, 4.7; 95% CI, 1.3-16.9; P=0.010).
  • PLEIADES is a phase 2 study evaluating the clinical benefit of DARZALEX FASPRO administered in combination with 4 standard-of-care treatment regimens in patients with multiple myeloma (MM).
    • Chari et al (2021)11 presented updated safety and efficacy results of the PLEIADES study with a median follow-up of 3.9 months for D-VRd (primary analysis), 14.3 months for DARZALEX FASPRO in combination with bortezomib, melphalan, and prednisone (D-VMP), and 14.7 months for DARZALEX FASPRO in combination with lenalidomide and dexamethasone (D-Rd). MRD-negativity rates were 16.4% (90% CI, 9.4-25.7) in the D-VMP cohort and 15.4% (90% CI, 8.6-24.7) in the D-Rd cohort.
    • Moreau et al (2020)12 presented updated safety and efficacy results of the PLEIADES study with a median follow-up of 9.2 months for DARZALEX FASPRO in combination with carfilzomib and dexamethasone (D-Kd; primary analysis), 25.7 months for D-Rd, and 25.2 months for D-VMP. MRD-negativity rates were evaluated via next-generation sequencing (NGS) at a sensitivity threshold of 10-5. MRD-negativity rates were 24.2% in the D-Kd cohort, 20% in the D-Rd cohort, and 25.4% in the D-VMP cohort. MRD-negative ≥CR rates were 21.2% in the D-Kd cohort, 20% in the D-Rd cohort, and 25.4% in the D-VMP cohort.
  • Several subgroup analyses that reported on MRD outcomes with the use of DARZALEX FASPRO were identified. These analyses are listed in the References section for your information.13-22

CLINICAL DATA

Phase 3 Study of D-VRd in Transplant-Ineligible Patients with NDMM

CEPHEUS (MMY3019; NCT03652064) is a phase 3, randomized, open-label, multicenter, study evaluating the efficacy and safety of D-VRd vs VRd in patients with NDMM who are TIE or for whom transplant is not planned as initial therapy (transplant deferred).1,23

Final Analysis of TIE Patients in the CEPHEUS Study

Usmani et al (2026)2 reported the final analysis of TIE patients in the CEPHEUS study at a median follow-up of 76 months.

Results

Patient Characteristics

Baseline Characteristics of TIE Population24
Characteristic
D-VRd (n=144)
VRd (n=145)
Median age (range), years
72 (58-79)
72 (51-80)
   <70 years, n (%)
35 (24.3)
35 (24.1)
   70 to <75 years, n (%)
68 (47.2)
65 (44.8)
   ≥75 years, n (%)
41 (28.5)
45 (31.0)
Male, n (%)
65 (45.1)
82 (56.6)
ECOG PSa, n (%)
   0
52 (36.1)
57 (39.3)
   1
75 (52.1)
78 (53.8)
   2
17 (11.8)
10 (6.9)
IMWG frailty scoreb, n (%)
   0 (fit)
82 (56.9)
88 (60.7)
   1 (intermediate fitness)
62 (43.1)
57 (39.3)
IFM frailty score, n (%)
   Nonfrail (0-1)
96 (66.7)
110 (75.9)
   Frail (≥2)
48 (33.3)
35 (24.1)
Type of myeloma by immunofixation or serum FLC assay, n (%)
   IgG
92 (63.9)
78 (53.8)
   IgA
26 (18.1)
42 (29.0)
   IgD
2 (1.4)
2 (1.4)
   Light chain
20 (13.9)
19 (13.1)
   Biclonal
4 (2.8)
3 (2.1)
   Unknown
0
1 (0.7)
Extramedullary plasmacytomas, n (%)
9 (6.3)
12 (8.3)
ISS disease stagec, n (%)
   I
50 (34.7)
48 (33.1)
   II
54 (37.5)
57 (39.3)
   III
40 (27.8)
40 (27.6)
Cytogenetic risk profiled, n (%)
   Standard
105 (72.9)
111 (76.6)
   High
20 (13.9)
18 (12.4)
   Unevaluable or missing
19 (13.2)
16 (11.0)
Abbreviations: D-VRd, DARZALEX FASPRO + bortezomib + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; FLC, free light chain; IFM, Intergroupe Francophone du Myelome; Ig, immunoglobulin; IMWG, International Myeloma Working group; ISS, International Staging System; TIE, transplant-ineligible; VRd, bortezomib + lenalidomide + dexamethasone.
aECOG PS is scored on a scale of 0-5, with 0 indicating no symptoms and higher scores indicating increasing disability.
bTotal additive frailty is scored on a scale of 0-5 based on age, comorbidities, and cognitive and physical conditions, with 0 indicating fit, 1 indicating intermediate fitness, and ≥2 indicating frail, per the Myeloma Geriatric Assessment score (http://www.myelomafrailtyscorecalculator.net/).
cBased on the combination of serum β2-microglobulin and albumin levels. Higher stages indicate more advanced disease.
dBased on fluorescence in situ hybridization; high risk was defined as the presence of del(17p), t(4;14), and/or t(14;16).
Efficacy
  • Overall MRD negativity rates (10-5) in patients with ≥CR was higher in the D-VRd arm vs the VRd arm, with 61.1% of patients in the D-VRd arm achieving overall MRD negativity vs 40.0% in the VRd arm (OR, 2.35; 95% CI, 1.47-3.77). See Table: Summary of MRD Negativity Rates (TIE Subgroup).2
    • Sustained MRD negativity rate at ≥12 and ≥24 months was higher in the D-VRd arm vs the V-Rd arm.

Summary of MRD Negativity Rates (TIE Subgroup)2
Parameter, n (%)
D-VRd
(n=144)
VRd
(N=145)
OR (95% CI)
P-value
Overall MRD negativity (≥CR) ratea
   10-5 threshold
61.1
40.0
2.35 (1.47-3.77)
0.0004
   10-6 threshold
46.5
27.6
2.27 (1.39-3.71)
0.0010
Sustained MRD negativity (≥CR) rate ≥12 monthsb
   10-5 threshold
49.3
29.0
2.40 (1.47-3.91)
0.0005
   10-6 threshold
37.5
16.6
3.01 (1.73-5.24)
<0.0001
Sustained MRD negativity (≥CR) rate ≥24 monthsb
   10-5 threshold
44.4
23.4
2.62 (1.58-4.36)
0.0002
   10-6 threshold
30.6
15.2
2.45 (1.38-4.37)
0.0020
Abbreviations: CI, confidence interval, CR, complete response; D-VRd, DARZLEX FASPRO + bortezomib + lenalidomide + dexamethasone; MRD, minimal residual disease; OR, odds ratio; TIE, transplant ineligible; VRd, bortezomib + lenalidomide + dexamethasone.
aThe proportion of patients who achieved MRD negativity and ≥CR.
bSustained MRD negativity was defined as 2 consecutive MRD negative reads ≥12 months (±1) or 24 months (±3) apart with no MRD-positive result in between.

Prespecified Subgroup Analysis of MRD Negativity (TIE Subgroup)2
Subgroup
D-VRd
VRd
OR (95% CI)
MRD negativity (≥CR; 10-5), n/N (%)
Sex
   Male
43/65 (66.2)
29/82 (35.4)
3.57 (1.80-7.08)
   Female
45/79 (57.0)
29/63 (46.0)
1.55 (0.80-3.02)
Age
   <70 years
26/35 (74.3)
15/35 (42.9)
3.85 (1.40-10.59)
   ≥70 years
62/109 (56.9)
43/110 (39.1)
2.06 (1.20-3.52)
Region
   Europe
55/96 (57.3)
37/90 (41.1)
1.92 (1.07-3.44)
   North America
20/31 (64.5)
12/28 (42.9)
2.42 (0.85-6.92)
   Other
13/17 (76.5)
9/27 (33.3)
6.50 (1.64-25.76)
Baseline ISS
   I
33/50 (66.0)
20/48 (41.7)
2.72 (1.20-6.17)
   II
32/54 (59.3)
26/57 (45.6)
1.73 (0.82-3.68)
   III
23/40 (57.5)
12/40 (30.0)
3.16 (1.26-7.94)
Cytogenetic Risk
   High risk
10/20 (50.0)
9/18 (50.0)
1.00 (0.28-3.57)
   Standard risk
67/105 (63.8)
44/111 (39.6)
2.68 (1.55-4.66)
Baseline ECOG PS
   0
30/52 (57.7)
26/57 (45.6)
1.63 (0.76-3.47)
   ≥1
58/92 (63.0)
32/88 (36.4)
2.99 (1.63-5.48)
Abbreviations: CI, confidence interval; CR, complete response; D-VRd, DARZLEX FASPRO + bortezomib + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance score; ISS, International Staging System; MRD, minimal residual disease; OR, odds ratio; TIE, transplant ineligible; VRd, bortezomib + lenalidomide + dexamethasone.

Expanded MRD Analysis of the Phase 3 CEPHEUS Study

Zweegman et al (2024)3 presented an expanded analysis of MRD outcomes from the CEPHEUS study in patients with NDMM who were ineligible for SCT or for whom transplant was deferred.

Results

Efficacy

  • A summary of the cumulative and sustained MRD-negativity (≥CR) rates is presented in Table: Summary of Cumulative and Sustained MRD-Negativity (≥CR) Rates - CEPHEUS Expanded Analysis.3
    • D-VRd improved cumulative MRD-negativity rates (both 10-5 and 10-6 sensitivities) vs VRd alone at all prespecified timepoints.
    • D-VRd almost doubled sustained MRD-negativity (≥) CR rates at 12, 24, and 36 months.
    • Among patients who achieved both MRD-negativity (10-6 sensitivity) and ≥CR with D-VRd, >85% were alive and progression free at 54 months.

Summary of Cumulative and Sustained MRD-Negativity (≥CR) Rates - CEPHEUS Expanded Analysis3
Parameter
D-VRd
(n=197)
VRd
(n=198)
OR (95% CI)
P Value
Cumulative MRD-negativity (10-5 sensitivity; ≥CR), %
   12 months
43.1
28.3
-
-
   24 months
56.9
35.9
-
-
   36 months
59.9
37.4
-
-
   48 months
60.9
38.4
-
-
Cumulative MRD-negativity (10-6 sensitivity; ≥CR), %
   12 months
22.8
11.1
-
-
   24 months
38.1
22.2
-
-
   36 months
40.6
25.3
-
-
   48 months
45.2
27.3
-
-
Sustained MRD-negativity (10-5 sensitivity; ≥CR)a, %
   ≥12 monthsb
49.2
27.3
2.56 (NR)
<0.0001
   ≥24 monthsc
42.1
22.7
2.47 (NR)
<0.0001
   ≥36 monthsd
29.9
15.2
2.37 (NR)
0.0005
Sustained MRD-negativity (10-6 sensitivity; ≥CR)a, %
   ≥12 monthsb
34
16.2
NR
NR
   ≥24 monthsc
27.9
13.6
NR
NR
   ≥36 monthsd
18.8
8.6
NR
NR
Abbreviations: CI, confidence interval; CR, complete response; D-VRd, DARZALEX FASPRO + bortezomib + lenalidomide + dexamethasone; MRD, minimal residual disease; NR, not reported; OR, odds ratio; VRd, bortezomib + lenalidomide + dexamethasone.
aAt any time during the study.
bProportion of patients who achieved ≥CR and achieved an MRD-negative status at 2 bone marrow assessments that are 12 month apart with an allotted window of ±1 month, without an MRD-positive status in between.
cAchieving an MRD-negative status at 2 bone marrow assessments that are 24 months apart with an allotted window of ±3 months, without an MRD-positive status in between.
dAchieving an MRD-negative status at 2 bone marrow assessments that are 36 months apart with an allotted window of ±3 months, without an MRD-positive status in between.
  • D-VRd vs VRd showed PFS benefit regardless of the MRD-negativity status (10-6 sensitivity).3
    • The overall MRD-negativity rate (10-6 sensitivity) for D-VRd vs VRd was 46.2% vs 27.3%, respectively, and the overall MRD-positivity rate (10-6 sensitivity) was 53.8% vs 72.7%, respectively.
    • At 54 months, the estimated PFS by MRD-negativity status (10-6 sensitivity) was 86.2% vs 79% and by MRD-positivity status was 51% vs 36.5% for D-VRd vs VRd, respectively.
  • Analyses of MRD-negativity (with ≥CR) rates in prespecified subgroups appeared to consistently favor D-VRd over VRd across these prespecified subgroups and are summarized in Table: MRD-Negativity (≥CR) Rates in Prespecified Subgroups.3

MRD-Negativity (≥CR) Rates in Prespecified Subgroups3
Subgroups,
n/N (%)
D-VRd
VRd
OR
(95% CI)
D-VRd
VRd
OR
(95% CI)
10-5 Sensitivity
10-6 Sensitivity
Sex
   Male
54/87
(62.1)
39/111
(35.1)
3.02
(1.69-5.41)
42/87
(48.3)
28/111
(25.2)
2.77
(1.52-5.04)
   Female
66/110
(60)
39/87
(44.8)
1.85
(1.04-3.26)
49/110
(44.5)
26/87
(29.9)
1.88
(1.04-3.41)
Age
   <70 years
59/88
(67)
36/88
(40.9)
2.94
(1.59-5.44)
44/88
(50)
25/88
(28.4)
2.52
(1.35-4.70)
   ≥70 years
61/109
(56)
42/110
(38.2)
2.06
(1.20-3.53)
47/109
(43.1)
29/110
(26.4)
2.12
(1.20-3.74)
Region
   Europe
69/120
(57.5)
46/116
(39.7)
2.06
(1.23-3.46)
57/120
(47.5)
34/116
(29.3)
2.18
(1.28-3.73)
   North America
21/37
(56.8)
13/31
(41.9)
1.82
(0.69-4.77)
14/37
(37.8)
9/31
(29)
1.49
(0.54-4.13)
   Other
30/40
(75)
19/51
(37.3)
5.05
(2.03-12.60)
20/40
(50)
11/51
(21.6)
3.64
(1.46-9.04)
Weight
   ≤65 kg
40/58
(69)
22/63
(34.9)
4.14
(1.94-8.86)
31/58
(53.4)
18/63
(28.6)
2.87
(1.35-6.09)
   >65-85 kg
58/101
(57.4)
31/88
(35.2)
2.48
(1.38-4.47)
45/101
(44.6)
19/88
(21.6)
2.92
(1.54-5.54)
   >85 kg
22/38
(57.9)
25/47
(53.2)
1.21
(0.51-2.87)
15/38
(39.5)
17/47 (36.2)
1.15
(0.48-2.78)
ISS staging
   I
45/68
(66.2)
30/68
(44.1)
2.48
(1.24-4.96)
32/68
(47.1)
22/68
(32.4)
1.86
(0.93-3.73)
   II
47/73
(64.4)
29/75
(38.7)
2.87
(1.47-5.59)
37/73
(50.7)
17/75
(22.7)
3.51
(1.73-7.13)
   III
28/56
(50)
19/55
(34.5)
1.89
(0.88-4.07)
22/56
(39.3)
15/55
(27.3)
1.73
(0.78-3.84)
Cytogenetic risk
   High risk
12/25
(48)
15/27
(55.6)
0.74
(0.25-2.20)
8/25
(32)
12/27
(44.4)
0.59
(0.19-1.83)
   Standard risk
95/149
(63.8)
57/149
(38.3)
2.84
(1.78-4.54)
71/149
(47.7)
37/149
(24.8)
2.76
(1.69-4.50)
ECOG PS score
   0
41/71
(57.7)
36/84
(42.9)
1.82
(0.96-3.45)
28/71
(39.4)
27/84
(32.1)
1.37
(0.71-2.66)
   ≥1
79/126
(62.7)
42/114
(36.8)
2.88
(1.71-4.87)
63/126
(50)
27/114
(23.7)
3.22
(1.85-5.61)
Abbreviations: CI, confidence interval; D-VRd, DARZALEX FASPRO + bortezomib + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; MRD, minimal residual disease; OR, odds ratio; VRd, bortezomib + lenalidomide + dexamethasone.

Phase 3 Study of D-VRd in Transplant-Eligible Patients with NDMM

PERSEUS (MMY3014; NCT03710603) is a phase 3, randomized, open-label, multicenter study evaluating the efficacy and safety D-VRd vs VRd induction and consolidation followed by maintenance with D-R in the D-VRd group or R in the VRd group in patients with NDMM eligible for ASCT.4

Analysis of Sustained MRD-Negativity from the Phase 3 PERSEUS Study

Moreau et al (2025)5 presented findings from the phase 3 PERSEUS study, highlighting the impact of sustained MRD-negativity on PFS and the incidence of functionally high-risk disease, defined as those experiencing relapse or progression within 18 months of treatment initiation, who often have poorer survival outcomes.

Results

Patient Characteristics

Sustained MRD Negativity ≥CR (10‒5) ≥12 Months Baseline Demographics and Clinical Characteristics5
Characteristic
Sustained (≥12 months) MRD negativity ≥CR
(10–5) D-VRd
(n=230)
Non-sustained (≥12 months) MRD negativity ≥CR (10-5) D-VRd
(n=125)
Median age, years
60.0
61.0
Male, n (%)
131 (57.0)
80 (64.0)
ECOG PS, n (%)
   0
150 (65.2)
71 (56.8)
   1
64 (27.8)
50 (40.0)
   ≥2
16 (6.9)
4 (3.2)
ISS staginga, n (%)
   I
128 (55.7)
58 (46.4)
   II
69 (30.0)
45 (36.0)
   III
33 (14.3)
22 (17.6)
Standard cytogenetic risk, n (%)
183 (79.6)
81 (64.8)
High cytogenetic riskb, n (%)
37 (16.1)
39 (31.2)
   del(17p)
14 (6.1)
22 (17.6)
   t(4;14)
17 (7.4)
16 (12.8)
   t(14;16)
7 (3.0)
4 (3.2)
Abbreviations: CR, complete response; D-VRd, daratumumab + bortezomib + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; MRD, minimal residual disease.
aBased on the combination of serum β2-microglobulin and albumin levels
bBased on fluorescence in situ hybridization.
Efficacy
  • D-VRd vs VRd more than doubled the rates of sustained MRD-negativity ≥CR (10-5 sensitivity threshold) at ≥12 months (64.8% vs 29.7%; OR, 4.42; 95% CI, 3.22-6.08; P<0.0001) and ≥24 months (55.8% vs 22.6%; OR, 4.36; 95% CI, 3.15-6.05; P<0.0001), respectively.5

Summary of Sustained MRD-negativity Rates (10-5 Sensitivity Threshold) by Subgroups5
Subgroup
D-VRd
VRd
OR (95% CI)
Number of Patients With MRD-Negativity/
Total Number of Patients (%)
Sustained MRD negativity (10-5) ≥12 months
   Sex
      Male
131/211 (62.1)
62/205 (30.2)
3.78 (2.51-5.68)
      Female
99/144 (68.8)
43/149 (28.9)
5.42 (3.29-8.94)
   Age
      <65 years
180/261 (69.0)
78/267 (29.2)
5.38 (3.71-7.81)
      ≥65 years
50/94 (53.2)
27/87 (31.0)
2.53 (1.37-4.64)
   Race
      White
216/330 (65.5)
93/323 (28.8)
4.69 (3.37-6.52)
      Other
14/25 (56.0)
12/31 (38.7)
2.02 (0.69-5.88)
   ISS staging
      I
128/186 (68.8)
58/178 (32.6)
4.57 (2.94-7.10)
      II
69/114 (60.5)
35/125 (28.0)
3.94 (2.29-6.78)
      III
33/55 (60.0)
12/50 (24.0)
4.75 (2.04-11.05)
   Type of MM
      lgG
136/204 (66.7)
50/185 (27.0)
5.40 (3.49-8.35)
      Non-lgG
52/78 (66.7)
31/96 (32.3)
4.19 (2.22-7.92)
   Cytogenetic risk
      Standard risk
183/264 (69.3)
83/266 (31.2)
4.98 (3.45-7.20)
      High risk
37/76 (48.7)
20/78 (25.6)
2.75 (1.40-5.42)
      Intermediate
10/15 (66.7)
2/10 (20.0)
8.00 (1.21-52.69
   ECOG PS score
      0
150/221 (67.9)
71/230 (30.9)
4.73 (3.18-7.04)
      ≥1
80/134 (59.7)
34/124 (27.4)
3.92 (2.32-6.62)
Sustained MRD negativity (10-5) ≥24 months
   Sex
      Male
105/211 (49.8)
44/205 (21.5)
3.62 (2.36-5.57)
      Female
77/144 (53.5)
30/149 (20.1
4.56 (2.72-7.65)
   Age
      <65 years
141/261 (54.0)
54/267 (20.2)
4.63 (3.15-6.81)
      ≥65 years
41/94 (43.6)
20/87 (23.0)
2.59 (1.36-4.94)
   Race
      White
172/330 (52.1)
68/323 (21.1)
4.08 (2.89-5.76)
      Other
10/25 (40.0)
6/31 (19.4)
2.78 (0.84-9.20)
   ISS staging
      I
105/186 (56.5)
44/178 (24.7)
3.95 (2.52-6.17)
      II
53/114 (46.5)
21/125 (16.8)
4.30 (2.37-7.81)
      III
24/55 (43.6)
9/50 (18.0)
3.53 (1.44-8.65)
   Type of MM
      lgG
105/204 (51.5)
35/185 (18.9)
4.55 (2.87-7.19)
      Non-lgG
46/78 (59.7)
19/96 (19.8)
5.83 (2.97-11.44
   Cytogenetic risk
      Standard risk
143/264 (54.2)
58/266 (21.8)
4.24 (2.90-6.19)
      High risk
29/76 (38.2)
14/78 (17.9)
2.82 (1.34-5.92)
      Intermediate
10/15 (66.7)
2/10 (20.0)
8.00 (1.21-52.69)
   ECOG PS score
      0
121/221 (54.8)
49/230 (21.3)
4.47 (2.96-6.75)
      ≥1
61/134 (45.5)
25/124 (20.2)
3.31 (1.90-5.76)

Phase 3 Study of D-R Maintenance in Patients with NDMM

AURIGA (MMY3021; NCT03901963) is a phase 3, randomized, open-label, active-controlled, multicenter 3 study evaluating the conversion rate to MRD-negativity after maintenance treatment with D-R vs lenalidomide alone in patients with NDMM who are MRD-positive after ASCT.6,7

Updated Analysis of the Phase 3 AURIGA Study

Anderson et al (2025)8 presented updated efficacy and safety results from the AURIGA study 24 months from the start of maintenance therapy, with a median follow-up of 40.3 months.

Results

Patient Characteristics

Baseline Demographics and Disease Characteristics of the ITT Population6
D-R (n=99)
R (n=101)
Median age (range), years
63 (35-77)
62 (35-78)
   <65 years, n (%)
61 (61.6)
61 (60.4)
   65-70 years, n (%)
23 (23.2)
21 (20.8)
   ≥70 years, n (%)
15 (15.2)
19 (18.8)
Sex, n (%)
   Male
61 (61.6)
58 (57.4)
   Female
38 (38.4)
43 (42.6)
Race, n (%)
   White
67 (67.7)
68 (67.3)
   Black or African American
20 (20.2)
24 (23.8)
   Asian
5 (5.1)
1 (1)
   American Indian or Alaska Native
0 (0)
1 (1)
   Othera
5 (5.1)
5 (5)
   NR
2 (2)
2 (2)
ECOG PS, n (%)
   0
45 (45.5)
55 (54.5)
   1
52 (52.5)
44 (43.6)
   2
2 (2)
2 (2)
ISS disease stageb, n (%)
   I
40 (44)
38 (38.8)
   II
28 (30.8)
37 (37.8)
   III
23 (25.3)
23 (23.5)
Median induction cycles (range)c, n
5 (4-8)
5 (4-8)
Cytogenetic risk at diagnosisd, n (%)
   Standard risk
63 (68.5)
66 (74.2)
   High riske
22 (23.9)
15 (16.9)
      del(17p)
13 (14.1)
3 (3.4)
      t(4;14)
10 (10.9)
12 (13.5)
      t(14;16)
6 (6.5)
7 (7.9)
   Unknown
7 (7.6)
8 (9)
Revised cytogenetic risk at diagnosisf, n (%)
   Standard risk
52 (55.9)
53 (59.6)
   High riskg
32 (34.4)
30 (33.7)
      del(17p)
13 (14)
3 (3.4)
      t(4;14)
10 (10.8)
12 (13.5)
      t(14;16)
6 (6.5)
7 (7.9)
      t(14;20)
1 (1.1)
2 (2.2)
      gain/amp(1q21)
16 (17.2)
22 (24.7)
   Unknown
9 (9.7)
6 (6.7)
Abbreviations: D-R, DARZALEX FASPRO+lenalidomide; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; ITT, intention-to-treat; NR, not reported; R, lenalidomide.
aPatients reporting multiple races.
bD-R vs R: n=91 vs n=98, respectively.
cD-R vs R: n=98 vs n=99, respectively.
dD-R vs R: n=92 vs n=89, respectively.
eHigh risk is defined as positive for any of del(17p), t(14;16), or t(4;14).
fD-R vs R: n=93 vs n=89, respectively.
gRevised high-risk cytogenetics is defined as ≥1 abnormality from del(17p), t(4;14), t(14;16), t(14;20), and gain/amp(1q21).

Efficacy

  • The MRD status and conversion rates in the ITT population are summarized in Table: Summary of MRD Status and Conversion Rates in the ITT Population.8 
    • The overall MRD-negativity (10-5) conversion rate was significantly higher for D-R vs R (60.6% vs 28.7%; OR, 3.92; 95% CI, 2.16-7.14; P<0.0001).
    • The D-R arm yielded a more than 2 times greater sustained MRD-negativity (10-5) rates at ≥6-months (42.4% vs 17.8%) and at ≥12 months (29.3% vs 7.9%) than the R arm.

Summary of MRD Status and Conversion Rates in the ITT Population8 

Parameter
D-R
R
ORa (95% CI)
P Valueb
Overall MRD-negativity conversion rate, %c
   10-5 sensitivity
60.6
28.7
3.92 (2.16-7.14)
<0.0001
   10-6 sensitivity
36.4
14
3.59 (1.78-7.23)
0.0003
Overall MRD-negativity (≥CR) conversion rate, %c
   10-5 sensitivity
55.6
23.8
4.11 (2.23-7.59)
<0.0001
   10-6 sensitivity
35.4
10.9
4.55 (2.14-9.66)
<0.0001
MRD-negativity accumulative conversion rate at 12 months from start of maintenance, %
   10-5 sensitivity
50.5
18.8
4.51 (2.37-8.57)
<0.0001
   10-6 sensitivity
23.2
5.0
5.97 (2.15-16.58)
0.0002
MRD-negativity accumulative conversion rate at 18 months from start of maintenance, %
   10-5 sensitivity
56.6
21.8
4.81 (2.57-9.00)
<0.0001
   10-6 sensitivity
30.3
8.9
4.44 (1.98-9.96)
0.0001
MRD-negativity accumulative conversion rate at 24 months from start of maintenance, %
   10-5 sensitivity
60.6
26.7
4.33 (2.36-7.94)
<0.0001
   10-6 sensitivity
35.4
10.9
4.51 (2.13-9.56)
<0.0001
Sustained MRD-negativity (10-5), %
   ≥6 monthsd
42.4
17.8
3.45 (1.80-6.61)
0.0002
   ≥12 monthsd
29.3
7.9
4.88 (2.09-11.38)
0.0001
Abbreviations: CI, confidence interval; CR, complete response; D-R, DARZALEX FASPRO + lenalidomide; ITT, intention-to-treat; MRD, minimal residual disease; OR, odds ratio; R, lenalidomide.
aMantel–Haenszel estimate of the common OR for stratified tables was used. The stratification factor was BL cytogenetic risk per investigator assessment (high vs standard/unknown), as used for randomization. An OR >1 indicates an advantage for D-R.
bP value from Fisher’s exact test.
cAt a median follow-up of 40.3 months.
dDefined as those who achieved MRD-negative status (at 10–5) in 2 bone marrow aspirate assessments with a minimum of 6 or 12 months apart (based on specified endpoint), without any assessment showing MRD-positive status in between assessments.

Subgroup Analysis of MRD-Negativity (10-5) Conversion Rates in Patient Subgroups8 

Subgroup, n/N (%)
D-R
R
OR (95% CI)
Sex
   Male
37/61 (60.7)
17/58 (29.3)
3.72 (1.73-7.98)
   Female
23/38 (60.5)
12/43 (27.9)
3.96 (1.56-10.05)
Age
   <65 years
35/61 (57.4)
19/61 (31.1)
2.98 (1.42-6.25)
   ≥65 years
25/38 (65.8)
10/40 (25.0)
5.77 (2.16-15.38)
Race
   White
36/67 (53.7)
21/68 (30.9)
2.60 (1.29-5.25)
   Black or African American
16/20 (80.0)
7/24 (29.2)
9.71 (2.38-39.61)
   Other
8/12 (66.7)
1/9 (11.1)
16.00 (1.45-176.45)
Weight
   ≤70 kg
15/23 (65.2)
4/18 (22.2)
6.56 (1.61-26.72)
   >70 kg
45/76 (59.2)
25/81 (30.9)
3.25 (1.69-6.27)
Baseline ECOG PS score
   0
27/45 (60.0)
12/55 (21.8)
5.37 (2.24-12.89)
   ≥1
33/54 (61.1)
17/46 (37.0)
2.68 (1.19-6.03)
ISS staging at diagnosis
   I
22/40 (55.0)
14/38 (36.8)
2.10 (0.85-5.19)
   II
15/28 (53.6)
11/37 (29.7)
2.73 (0.98-7.59)
   III
18/23 (78.3)
3/23 (13.0)
24.00 (5.01-114.97)
Cytogenetic risk at diagnosis
   High riska
11/22 (50.0)
3/15 (20.0)
4.00 (0.88-18.22)
   Standard risk
40/63 (63.5)
20/66 (30.3)
4.00 (1.92-8.33)
Revised cytogenetic risk at diagnosis
   High riskb
19/32 (59.4)
6/30 (20.0)
5.85 (1.87-18.27)
   Standard risk
32/52 (61.5)
18/53 (34.0)
3.11 (1.40-6.90)
Cytogenic risk per IMS 2024 criteria
   High riskc
9/17 (52.9)
0/8 (0)
NE (NE-NE)
   Standard risk
42/67 (62.7)
25/68 (36.8)
2.89 (1.44-5.81)
Abbreviations: CI, confidence interval; D-R, DARZALEX FASPRO + lenalidomide; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System; MRD, minimal residual disease; NE, not evaluable; OR, odds ratio; R, lenalidomide.
aHigh-risk cytogenetics are defined as ≥1 abnormality including del(17p), t(4;14), and/or t(14;16).
bRevised high-risk cytogenetics are defined as ≥1 abnormality including del(17p), t(4;14), t(14;16), t(14;20), and/or gain/amp(1q21).
cHigh risk per the modified IMS 2024 criteria is defined as the presence of ≥20% del(17p), or the association of ≥2 of the following: t(4;14) or t(14;16) or t(14;20); gain/amp(1q21); or del(1p32) [in the AURIGA study, data were not available on TP53 mutations, baseline ß2M, and creatinine levels and differentiation between monoallelic versus biallelic del(1p32)].

Analysis of MRD Dynamics from the Phase 3 AURIGA Study

Chung et al (2025)9 presented an analysis of MRD dynamics in post-transplant patients with NDMM from the AURIGA study at a median follow up of 40.3 months. MRD dynamics, including MRD-positive recurrence, assesses development of a patient’s resistance to therapies for NDMM.

Results

Efficacy

Summary of MRD-Negative Conversion and Sustained Rates9 
Parameter
D-R
R
ORa
P-Valueb
Overall MRD-negativity conversion ratec, %
   10-5 threshold
60.6
29.7
3.74
<0.0001
   10-6 threshold
36.4
13.9
3.59
0.0003
Sustained MRD-negativity rated, %
   10-5 threshold
29.3
7.9
4.88
0.0001
   10-6 threshold
19.2
2.0
11.75
<0.0001
Abbreviations: D-R, DARZALEX FASPRO + lenalidomide; MRD, minimal residual disease; OR, odds ratio; PD, progressive disease; R, lenalidomide.aMantel-Haenszel estimate of the common OR for stratified tables was used. The stratification factor was baseline cytogenetic risk per investigator assessment (high vs standard/unknown), as used for randomization. An OR >1 indicates an advantage for D-R.bP value from Fisher’s exact test.
cDefined as the proportion of patients who achieved MRD negativity (10-5 or 10-6) by bone marrow aspirate at any time after baseline and prior to PD and subsequent antimyeloma therapy.dDefined as those who achieved MRD negative status (at 10-5 or 10-6) in 2 bone marrow aspirate assessments with a minimum of 12 months apart (based on specified endpoint), without any assessment showing MRD-positive status in between assessments.

Summary of MRD-Negative Conversion and MRD-Positive Recurrence (10-5, 10-6, and 10-5 only) Rates by Cytogenetic Risk at Diagnosis9 
Patients, n/N (%)
D-R (n=99)
R (n=101)
MRD-negative conversiona,d
   10-5 sensitivityb
60/99 (60.6)
30/101 (29.7)
      Standard riskc
45/70 (64.3)
25/74 (33.8)
      High risk
11/22 (50.0)
3/15 (20.0)
   10-6 sensitivitye
36/99 (36.4)
14/101 (13.9)
      Standard riskc
27/70 (38.6)
12/74 (16.2)
      High risk
6/22 (27.3)
2/15 (13.3)
   10-5 only sensitivityf
24/99 (24.2)
16/101 (15.8)
      Standard riskc
18/70 (25.7)
13/74 (17.6)
      High risk
5/22 (22.7)
1/15 (6.7)
MRD-positive recurrenced
   10-5 sensitivity
      Standard riskc
9/45 (20.0)
8/25 (32.0)
      High risk
6/11 (54.5)
1/3 (33.3)
   10-6 sensitivity
      Standard riskc
3/27 (11.1)
5/12 (41.7)
      High risk
2/6 (33.3)
1/2 (50.0)
   10-5 only sensitivity
      Standard riskc
7/18 (38.9)
6/13 (46.2)
      High risk
5/5 (100)
1/1 (100)
Abbreviations: D-R, DARZALEX FASPRO + lenalidomide; MRD, minimal residual disease; R, lenalidomide.aIncludes patients with ≥1 negative MRD test at the 10–5 threshold.bOf the 11 high-risk patients in the D-R group, 6 had del(17p), 4 had t(4;14), and 4 had t(14;16); all 3 high-risk patients in the R group had only t(4;14).  cFor this analysis, the standard-risk subgroups included patients with an incomplete cytogenetic panel. dMRD-negative conversion and MRD-positive recurrence rates are among patients with cytogenetic results for del(17p), t(4;14), and/or t(14;16) at diagnosis. One patient with MRD-positive recurrence in the D-R arm had no cytogenetic test results for del(17p), t(4;14), or t(14;16).eOf the 6 high-risk patients in the D-R group, 3 had del(17p), 3 had t(4;14), and 3 had t(14;16); both high-risk patients in the R group had only t(4;14).  fOf the 5 high-risk patients in the D-R group, 3 had del(17p), 1 had t(4;14), and 1 had t(14;16); the 1 high-risk patient in the R group had only t(4;14).  
  • MRD status (10-5 and 10-6) for D-R vs R alone was measured at 12, 18, and 24 months and is summarized in Table: Summary of MRD Status Over Time.9 
    • In the D-R group, MRD-negativity was achieved and maintained at higher rates than in the R alone group at both the 10-5 and 10-6 thresholds.

Summary of MRD Status Over Time9,a
Parameter
10-5 sensitivity
10-6 sensitivity
D-R (n=99)
R (n=101)
D-R (n=99)
R (n=101)
MRD status at 12 months from start of maintenance, %
   MRD-negative
50.0
19.6
22.4
5.1
   MRD-positive  
29.6
52.6
52.0
65.7
   Indeterminate/missed
8.2
8.2
13.3
9.1
   Treatment discontinuation
12.2
19.6
12.2
20.2
MRD status at 18 months from start of maintenance, %
   MRD-negative
43.9
13.4
23.5
7.1
   MRD-positive  
29.6
39.2
42.9
45.5
   Indeterminate/missed
10.2
12.4
17.3
12.1
   Treatment discontinuation
16.3
35.1
16.3
35.4
MRD status at 24 months from start of maintenance, %
   MRD-negative
42.9
16.5
26.5
4.0
   MRD-positive  
25.5
28.9
38.8
40.4
   Indeterminate/missed
11.2
12.4
14.3
13.1
   Treatment discontinuation
20.4
42.3
20.4
42.4
Abbreviations: D-R, DARZALEX FASPRO + lenalidomide; MRD, minimal residual disease; R, lenalidomide.
aIncludes patients with baseline MRD positivity
  • PFS favored D-R maintenance over R alone, with median PFS not yet reached for D-R compared with 47.2 months for R alone. See Table: Summary of PFS by Investigator Assessment.9 
    • No patient who achieved sustained MRD-negativity during D-R maintenance experienced disease progression or death.

Summary of PFS by Investigator Assessment9 
Parameter
D-R
R
HR (95% CI)a
P-Valueb
Median PFS, months
NR
47.2
0.55 (0.33-0.91)
0.0183
PFS events in patients achieving MRD-negative conversion, % (n/N)
   10-5 sensitivity
10.0 (6/60)
13.3 (4/30)
0.69 (0.20-2.47)
-
   10-6 sensitivity
2.8 (1/36)
21.4 (3/14)
0.23 (0.02-2.27)
-
PFS events in patients achieving sustained MRD-negativityc, % (n/N)
   10-5 sensitivity
0/29
25.0 (2/8)
-
-
   10-6 sensitivity
0/19
0/2
-
-
Abbreviations: CI, confidence interval; D-R, DARZALEX FASPRO + lenalidomide; MRD, minimal residual disease; HR, hazard ratio; PFS, progression free survival; R, lenalidomide.
aHR and 95% CI from a Cox proportional hazards model with treatment as the sole explanatory variable and stratified by baseline cytogenetic risk (high vs standard/unknown), as used for randomization. A HR <1 indicates an advantage for D-R.bP value from stratified log-rank test.
cPatients who achieved sustained MRD negativity lasting ≥12 months
  • Progression or death in patients with MRD-positive (10-5) recurrence is summarized in Table: Progression or Death in Patients with MRD Positive (10-5) Recurrence.9 
    • Of the 5 disease progressions observed in D-R treated MRD-positive (10-5) recurrent patients, 3 occurred in high-risk patients, with a median time to progression or death of about 16 months.
    • At the 10-6 threshold, progression or death after MRD-positive recurrence was observed in 16.7% of D-R patients versus 33.3% of R patients.

Progressiona or Death in Patients with MRD Positive (10-5) Recurrence9 
Parameter
D-Rb
R
PD/death in patients with MRD-positive (10–5) recurrence, % (n/N)
31.3 (5/16)
11.1 (1/9)
Median (range) time between recurrence and PD/death, months
15.9 (5.6-19.2)
13.1 (13.1-13.1)
Abbreviations: D-R, DARZALEX FASPRO + lenalidomide; MRD, minimal residual disease; PD, progressive disease; R, lenalidomide.
aPer investigator assessmentbAmong D-R patients, 3 had cytogenetic high risk at diagnosis, 4 had MRD positive (10-5) recurrence within 7 months

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 02 June 2026.

In response to your specific request, summarized in this response are the relevant data from company-sponsored studies pertaining to this topic.

 

References

Show
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5 Moreau P, Sonneveld P, Einsele H, et al. Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone with Dara + lenalidomide maintenance in transplant-eligible patients with newly diagnosed multiple myeloma: analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial. Oral Presentation presented at: The American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, USA.  
6 Badros A, Foster L, Anderson LD Jr, et al. Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study. Blood. 2025;145(3):300-310.  
7 Badros A, Foster L, Anderson LD Jr, et al. Subcutaneous daratumumab plus lenalidomide versus lenalidomide alone as maintenance therapy in newly diagnosed multiple myeloma after transplant: primary results from the phase 3 AURIGA study. Oral Presentation presented at: The 21st International Myeloma Society (IMS) Annual Meeting; September 25-28, 2024; Rio de Janeiro, Brazil.  
8 Anderson Jr LD, Chung A, Foster L, et al. Updated efficacy and safety results of subcutaneous daratumumab plus lenalidomide versus lenalidomide alone  as maintenance therapy in newly diagnosed multiple myeloma after transplant: AURIGA study. Poster presented at: 22nd International Myeloma Society (IMS) Annual Meeting; September 17-20, 2025; Toronto, Canada.  
9 Chung A, Anderson Jr LD, Foster L, et al. Minimal residual disease dynamics in post-transplant patients with newly diagnosed multiple myeloma who received daratumumab plus lenalidomide versus lenalidomide alone as maintenance therapy in the AURIGA study. Poster presented at: 67th American Society of Hematology (ASH) Annual Meeting & Exposition; December 6-9, 2025; Orlando, FL, USA.  
10 Dimopoulos M, Terpos E, Boccadoro M, et al. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(6):801-812.  
11 Chari A, Rodriguez-Otero P, McCarthy H, et al. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label phase II study. Br J Haematol. 2021;192(5):869-878.  
12 Moreau P, Chari A, Haenel M, et al. Subcutaneous daratumumab (DARA SC) plus standard-of-care (SoC) regimens in multiple myeloma (MM) across lines of therapy in the phase 2 PLEIADES study: initial results of the DARA SC plus carfilzomib/dexamethasone (D-Kd) cohort, and updated results for the DARA SC plus bortezomib/melphalan/prednisone (D-VMP) and DARA SC plus lenalidomide/dexamethasone (D-Rd) cohorts. Poster presented at: The 62nd American Society of Hematology (ASH) Annual Meeting & Exposition; December 5-8, 2020; Virtual.  
13 Rodriguez-Otero P, Moreau P, Dimopoulos MA, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) with DARA-R (D-R) maintenance in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM): analysis of minimal residual disease (MRD) in the PERSEUS trial. Oral Presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL, USA.  
14 Dimopoulos MA, Sonneveld P, Rodriguez-Otero P, et al. Daratumumab (DARA)/ bortezomib/lenalidomide/ dexamethasone (D-VRd) with D-R maintenance in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): analysis of PERSEUS based on cytogenetic risk. Poster presented at: The European Hematology Association (EHA) Hybrid Congress; June 13-16, 2024; Madrid, Spain.  
15 Dimopoulos MA, Sonneveld P, Rodriguez-Otero P, et al. Daratumumab (DARA SC)/bortezomib/lenalidomide/dexamethasone (D-VRd) with D-R maintenance in transplant-eligible (TE) newly diagnosed myeloma (NDMM): PERSEUS cytogenetic risk analysis. Oral Presentation presented at: 21st International Myeloma Society (IMS) Annual Meeting; September 25-28, 2024; Rio de Janeiro, Brazil.  
16 Rodriguez-Otero P, Voorhees P, Boccadoro M, et al. Daratumumab for newly diagnosed multiple myeloma: pooled analysis of patients aged ≥65 years from GRIFFIN and PERSEUS. [Published online ahead of print April 11, 2025]. Clin Lymphoma Myeloma Leuk. doi:10.1016/j.clml.2025.04.007.  
17 Foster L, Anderson LD Jr, Chung A, et al. Daratumumab plus lenalidomide (D-R) versus lenalidomide (R) alone as maintenance therapy in newly diagnosed multiple myeloma (NDMM) after transplant: analysis of the phase 3 AURIGA study among clinically relevant subgroups. Oral Presentation presented at: The 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA.  
18 Rodriguez-Otero P, Voorhees PM, Boccadoro M, et al. Daratumumab for newly diagnosed multiple myeloma: pooled analysis of patients aged ≥65 years from GRIFFIN and PERSEUS. Clin Lymphoma Myeloma Leuk. 2025.  
19 Mian H, Facon T, Cook G, et al. Dynamic frailty analysis of transplant-ineligible patients with NDMM in the phase 3 MAIA and CEPHEUS trials of daratumumab (Dara) + lenalidomide-dexamethasone (Rd) and bortezomib-Rd (VRd). Oral Presentation presented at: 22nd International Myeloma Society (IMS) Annual Meeting; September 17-20, 2025; Toronto, Canada.  
20 Zweegman S, Usmani SZ, Hungria V, et al. The phase 3 CEPHEUS trial of daratumumab plus bortezomib, lenalidomide, and dexamethasone in patients with transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: frailty subgroup analysis. Oral Presentation presented at: The 6th European Myeloma Network (EMN) Meeting; April 10-12, 2025; Athens, Greece.  
21 Bertamini L, Fokkema C, Rodriguez-Otero P, et al. Circulating tumor cells as a biomarker to identify high-risk transplant-eligible myeloma patients treated with bortezomib, lenalidomide, and dexamethasone with or without daratumumab during induction/consolidation, and lenalidomide with or without daratumumab during maintenance: results from the PERSEUS study. Oral Presentation presented at: The 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA.  
22 Bahlis NJ, Usmani SZ, Facon T, et al. Daratumumab + bortezomib, lenalidomide, and dexamethasone vs bortezomib, lenalidomide, and dexamethasone in transplant-ineligible/ transplant-deferred newly diagnosed multiple myeloma: phase 3 CEPHEUS trial cytogenetic subgroup analysis. Poster presented at: The American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, USA.  
23 Zweegman S, Usmani S, Chastian K, et al. Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab in patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy: a multicenter, randomized, phase 3 study (CEPHEUS). Poster presented at: The Annual Meeting of the American Society of Clinical Oncology (ASCO). May 31-June 4, 2019; Chicago, IL.  
24 Facon T, Zweegman S, Hungria V, et al. Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. Oral Presentation presented at: The American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, USA.  

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