J&J Medical Connect
DARZALEX®

(daratumumab)

+ Save link
J&J Medical Connect

Connect with us

Connect with us

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

DARZALEX® (daratumumab)

Medical Information

DARZALEX FASPRO® (daratumumab and hyaluronidase)

Last Updated: 09/12/2025

SUMMARY

  • MAIA is a phase 3 study evaluating the safety and efficacy of DARZALEX for intravenous (IV) use in combination with lenalidomide and dexamethasone (D-Rd) compared to lenalidomide plus dexamethasone (Rd) in transplant-ineligible newly diagnosed multiple myeloma (NDMM) patients.1,2
    • Facon et al (2019)1 reported the prespecified interim results of this ongoing study.
    • Facon et al (2025)3 reported the updated efficacy and safety results from the MAIA study at a long-term median follow-up of 64.5 months. The median progression-free survival (PFS) was 61.9 months vs 34.4 months in the D-Rd vs Rd arm, respectively (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.45-0.67; P<0.0001). The median overall survival (OS) was not reached in the D-Rd arm and was 65.5 months in the Rd arm (HR, 0.66; 95% CI, 0.53-0.83; P=0.0003). Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 95.9% vs 88.8% of patients from the D-Rd vs Rd arm, respectively. The most common (≥20%) grade 3/4 TEAEs with D-Rd vs Rd were neutropenia (54.1% vs 37.0%, respectively) and anemia (17.0% vs 21.6%, respectively).
    • Facon et al (2024)4 presented the results of the updated efficacy and safety analysis of the MAIA study. At a median follow-up of 89.3 months, a 33% reduction in the risk of death was observed with the D-Rd vs Rd arms. Median OS was reached for the D-Rd arm and was prolonged for patients in the D-Rd vs Rd arms (90.3 vs 64.1 months [HR, 0.67; 95% CI, 0.55-0.82; nominal P<0.0001]). Deaths were reported for 47.5% of patients in the D-Rd arm and 59.7% of patients in the Rd arm, mostly due to disease progression.
    • Other relevant subgroup analyses from MAIA Study have been referenced below.5-12
  • POLLUX was a phase 3 study evaluating the safety and efficacy of Rd and D-Rd in patients with relapsed or refractory multiple myeloma (RRMM).13
    • Dimopoulos et al (2023)14 reported updated efficacy and safety results from POLLUX at a median follow-up of 79.7 months. Median OS in the intention-to-treat (ITT) population with D-Rd was 67.6 months (95% CI, 53.1-80.5) with D-Rd and
      51.8 months (95% CI, 44.0-60.0) with Rd (HR, 0.73; 95% CI, 0.58-0.91; P=0.0044). The most common grade 3/4 (≥10%) TEAEs were neutropenia (D-Rd, 57.6%; Rd, 41.6%), anemia (D-Rd, 19.8%; Rd, 22.4%), pneumonia (D-Rd, 17.3%; Rd, 11%), thrombocytopenia (D-Rd, 15.5%; Rd, 15.7%), and diarrhea (D-Rd, 10.2%; Rd, 3.9%).
    • Other relevant subgroup analyses from POLLUX Study have been referenced below.15-20
  • PLEIADES is an ongoing, 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).21-25 Results from patients in the D-Rd arm are summarized below.
  • Other relevant literature that has been identified has been referenced below.26,27

PRODUCT LABELING

Clinical studies

DARZALEX in Combination with Lenalidomide and Dexamethasone in Patients with NDMM

MAIA (MMY3008; NCT02252172) is an international, phase 3, randomized, open-label, active-controlled, multicenter study in patients with NDMM not eligible for high dose chemotherapy and autologous stem cell transplantation (ASCT) (N=737).1,2 Facon et al (2021)28 reported the updated safety and efficacy results in the MAIA study at the prespecified interim OS analysis with a median follow-up of 56.2 months. Facon et al (2025)3 reported the updated efficacy and safety results from the MAIA study at a long-term median follow-up of 64.5 months. Facon et al (2024)4 presented updated efficacy and safety results at a median follow-up of 89.3 months.

Study Design/Methods

  • Eligible patients were randomized 1:1 to receive 28-day cycles of D-Rd or Rd until disease progression or unacceptable toxicity at the following dosage1,2:
    • D-Rd arm:
      • DARZALEX: 16 mg/kg IV weekly during cycles 1-2, every 2 weeks during cycles 3-6, then every 4 weeks during cycle 7+
      • Lenalidomide: 25 mg oral (PO) daily on days 1-21
      • Dexamethasone: 40 mg PO on days 1, 8, 15, and 22
    • Rd arm:
      • Lenalidomide and dexamethasone at the same dosage as the D-Rd arm.

Long-term Efficacy and Safety Analysis of the MAIA Study

Facon et al (2025)3 reported the updated efficacy and safety results from the MAIA study at a long-term median follow-up of 64.5 months.

Results

Patient Characteristics
  • A total of 737 (D-Rd, n=368; Rd, n=369) patients were randomized in this study.3
  • The median follow-up was 64.5 months (range, 0-77.6).3
  • Baseline characteristics of the ITT population were well balanced between the treatment arms and are summarized in Table: Demographic and Baseline Disease Characteristics of the ITT Population.
  • As of the clinical cutoff date of October 21, 2021, 233 (64.0%) vs 311 (85.2%) patients from the D-Rd vs Rd arm, respectively, discontinued treatment; the main reasons for discontinuation were progressive disease (PD; D-Rd, 29.4%; Rd, 35.9%) and adverse events (AEs; D-Rd, 15.7%; Rd, 24.4%).3

Demographic and Baseline Disease Characteristics of the ITT Population29
Characteristic
D-Rd
(n=368)
Rd
(n=369)
Age
   Median (range), years
73.0 (50-90)
74.0 (45-89)
ECOG PSa, n (%)
   0
127 (34.5)
123 (33.3)
   1
178 (48.4)
187 (50.7)
   ≥2
63 (17.1)
59 (16.0)
ISS disease stageb, n (%)
   I
98 (26.6)
103 (27.9)
   II
163 (44.3)
156 (42.3)
   III
107 (29.1)
110 (29.8)
Type of measurable disease, n (%)
   IgG
225 (61.1)
231 (62.6)
   IgA
65 (17.7)
66 (17.9)
   Otherc
9 (2.4)
10 (2.7)
   Detected in urine only
40 (10.9)
34 (9.2)
   Detected in serum FLC only
29 (7.9)
28 (7.6)
Cytogenetic riskd
   n
319
323
   Standard risk, n (%)
271 (85.0)
279 (86.4)
   High risk, n (%)
48 (15.0)
44 (13.6)
Median (range) time since initial diagnosis of MM, months
0.95 (0.1-13.3)
0.89 (0-14.5)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; FLC, free light chain; Ig, immunoglobulin; ISS, International Staging System; ITT, intention-to-treat; MM, multiple myeloma; Rd, lenalidomide + dexamethasone.
aECOG PS is scored on a scale of 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability.
bISS disease stage was based on the combination of serum β2-microglobulin and albumin.
cIncludes IgD, IgE, IgM, and biclonal disease.
dCytogenetic risk was assessed by fluorescence in situ hybridization or karyotype testing; high risk was defined as the presence of t(4;14), t(14;16), or del(17p).
Efficacy
  • The median PFS was 61.9 months vs 34.4 months in the D-Rd vs Rd arm, respectively (HR, 0.55; 95% CI, 0.45-0.67; P<0.0001).3
    • The estimated 60-month PFS rate was 52.1% vs 29.6% in the D-Rd vs Rd arm, respectively.
  • The most common reasons for confirmed PD in each group were biochemical (D-Rd, 76.2%; Rd, 83.6%), bone lesions (D-Rd, 16.4%; Rd, 13.6%), plasmacytomas (D-Rd, 8.2%; Rd, 4.5%), and other causes (D-Rd, 1.6%; Rd, 2.3%).3
  • The median OS was not reached (NR) in the D-Rd arm and was 65.5 months in the Rd arm (HR, 0.66; 95% CI, 0.53-0.83; P=0.0003).3
    • The estimated 60-month OS rate was 66.6% vs 53.6% in the D-Rd vs Rd arm, respectively.
  • The D-Rd vs Rd arm showed a significantly higher (all P<0.0001) overall response rate (ORR; 92.9% vs 81.6%), complete response or better (≥CR) rate (51.1% vs 30.1%), and very good partial response or better (≥VGPR) rate (81.5% vs 56.9%) as presented in Table: Response Rates in the ITT Population.3
    • The cumulative best response rate improved with continuous D-Rd treatment in patients who achieved ≥CR and ≥VGPR.
    • Continued D-Rd treatment markedly deepened the best response rate over time, with the ≥CR rate increasing from 8.2% by 6 months to 28.0% by 12 months, 40.8% by 18 months, 45.4% by 24 months, 48.1% by 30 months, and 51.1% by 48 months.
    • For patients who achieved ≥CR:
      • The median PFS was NR in either treatment arm (HR, 0.52; 95% CI, 0.35-0.76; P=0.0007).
      • The estimated 60-month PFS rate was 73.7% vs 53.8% in the D-Rd vs Rd arm, respectively.
      • The median OS was NR in either treatment arm (HR, 0.58; 95% CI, 0.37-0.91; P=0.0164).
      • The estimated 60-month OS rate was 81.7% vs 69.1% in the D-Rd vs Rd arm, respectively.
    • For patients who achieved VGPR:
      • The median PFS was 42.7 months vs 36.2 months in the D-Rd vs Rd, respectively (HR, 0.71; 95% CI, 0.51-0.99; P=0.0401).
      • The estimated 60-month PFS rate was 37.1% vs 23.2% in the D-Rd vs Rd arm, respectively.
      • The median OS was NR in the D-Rd arm and was 63.1 months in the Rd arm (HR, 0.78; 95% CI, 0.53-1.16; P=0.2256).
      • The estimated 60-month OS rate was 61.5% vs 53.0% in the D-Rd vs Rd arm, respectively.
  • The D-Rd vs Rd arm showed a significantly higher (all P<0.0001) minimal residual disease (MRD)-negativity rate (10-5 sensitivity; 32.1% vs 11.1%) and sustained MRD-negativity rate (10-5 sensitivity; ≥12 months, 18.8% vs 4.1%; ≥18 months, 16.8% vs 3.3%) as summarized in Table: Response Rates in the ITT Population.3
    • The MRD-negativity response rate deepened over time, increasing from 12.8% at 12 months to 20.4% at 18 months, 24.2% at 24 months, 27.4% at 30 months, 29.3% at 36 months, 31.5% at 48 months, and 31.8% at 60 months.
    • PFS and OS improved in patients who achieved MRD-negativity vs those who were MRD-positive in both treatment arms, with more patients in the D-Rd arm achieving MRD-negativity.
  • A total of 128 (35.2%) vs 194 (53.2%) patients from the D-Rd vs Rd arm, respectively, received subsequent therapy.3
    • In the D-Rd vs Rd arm, 9.4% vs 23.2% of patients received DARZALEX-containing treatment as their first subsequent therapy, respectively.
    • In the D-Rd vs Rd arm, 14.1% vs 48.5% of patients received DARZALEX-containing treatment as any subsequent line of therapy, respectively.
    • PFS on next line of therapy was 73.7 months vs 48.9 months in the D-Rd vs Rd arm, respectively (HR, 0.61; 95% CI, 0.49-0.76; P<0.0001).

Response Rates in the ITT Population3
Response, n (%)
D-Rd
(n=368)
Rd
(n=369)
P Value
ORR
342 (92.9)
301 (81.6)
<0.0001a
   ≥CR
188 (51.1)
111 (30.1)
<0.0001a
      sCR
131 (35.6)
58 (15.7)
<0.0001a
      CR
57 (15.5)
53 (14.4)
-
   ≥VGPR
300 (81.5)
210 (56.9)
<0.0001a
      VGPR
112 (30.4)
99 (26.8)
-
   PR
42 (11.4)
91 (24.7)
-
SD
11 (3.0)
55 (14.9)
-
PD
1 (0.3)
0 (0)
-
NE
14 (3.8)
13 (3.5)
-
MRD-negativity response rate (10-5 sensitivity), n (%)
118 (32.1)
41 (11.1)
<0.0001b
Sustained MRD-negativity response rate (10-5 sensitivity), n (%)
≥12 months
69 (18.8)
15 (4.1)
<0.0001b
≥18 months
62 (16.8)
12 (3.3)
<0.0001b
Abbreviations: CR, complete response; D-Rd, DARZALEX + lenalidomide + dexamethasone; ITT, intention-to-treat; MRD, minimal residual  disease; NE, not estimable; ORR, overall response rate; PD, progressive disease; PR, partial response; Rd, lenalidomide + dexamethasone; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.
aP value was calculated using the Cochran-Mantel-Haenszel chi-square test.
bP value was calculated using the Fisher’s exact test.
Safety
  • At clinical cutoff, 52 patients from the D-Rd arm discontinued lenalidomide ± dexamethasone but remained on the rest of the study treatment; 46 (88.5%) of these patients discontinued due to AEs.3
    • The median time to lenalidomide discontinuation was 37.8 months (range, 1-70).
    • The median duration of DARZALEX treatment was 66.2 months (range, 56-77).
    • The estimated 60-month PFS and OS rates were 98.1% and 100.0%, respectively.
    • Of the aforementioned 52 patients, 13 (25.0%) discontinued lenalidomide but continued DARZALEX + dexamethasone and 39 (75.0%) discontinued lenalidomide + dexamethasone and continued DARZALEX monotherapy.
      • In the 39 patients who discontinued lenalidomide + dexamethasone and continued DARZALEX monotherapy, the median time to discontinuation was 39.1 months (range, 3-67) and the median DARZALEX treatment duration was 65.6 months (range, 56-73). The estimated 60-month PFS and OS rates were 97.4% and 100.0%, respectively.
      • One patient in the D-Rd arm stopped DARZALEX after 15 days due to AEs but continued lenalidomide treatment without progression at the clinical cutoff.
  • No new safety concerns were observed with a longer follow-up.3
    • Grade 3/4 TEAEs occurred in 95.9% vs 88.8% of patients from the D-Rd vs Rd arm, respectively.
      • Among patients aged ≥75 years, grade 3/4 TEAEs occurred in 95.5% vs 95.0% of patients from the D-Rd vs Rd arm, respectively.
      • Among patients aged ≥80 years, grade 3/4 TEAEs occurred in 92.3% vs 95.7% of patients from the D-Rd vs Rd arm, respectively.
      • The rates of common grade 3/4 TEAEs in patients aged ≥75 years and those aged ≥80 years were similar to those in the overall study population.
    • The most common (≥20%) grade 3/4 TEAEs were neutropenia and anemia as summarized in Table: Most Common Any-Grade or Grade 3/4 TEAEs in the Safety Population
    • Grade 3/4 infections occurred in 42.6% vs 29.6% of patients from the D-Rd vs Rd arm, respectively.
    • Serious TEAEs occurred in 78.8% vs 71.0% of patients from the D-Rd vs Rd arm, respectively, with pneumonia being the most common serious TEAE (18.7% vs 10.7%, respectively).
    • The overall discontinuation rate due to TEAEs was lower in the D-Rd vs Rd arm (14.6% vs 23.8%).
      • Discontinuation of lenalidomide due to TEAEs was reported in 36.8% vs 24.4% of patients from the D-Rd vs Rd arm, respectively.
      • Discontinuation of dexamethasone due to TEAEs was reported in 39.8% vs 36.2% of patients from the D-Rd vs Rd arm, respectively.
      • Discontinuation of DARZALEX due to TEAEs was reported in 14.6% of patients.
    • TEAEs leading to death were reported in 9.9% vs 9.3% of patients from the D-Rd vs Rd arm, respectively.

Most Common Any-Grade or Grade 3/4 TEAEs in the Safety Populationa,3
TEAE, n (%)
D-Rd (n=364)
Rd (n=365)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Hematologic
   Neutropenia
224 (61.5)
197 (54.1)
166 (45.5)
135 (37.0)
   Anemia
154 (42.3)
62 (17.0)
150 (41.1)
79 (21.6)
Nonhematologic
   Diarrhea
240 (65.9)
33 (9.1)
188 (51.5)
22 (6.0)
   Fatigue
164 (45.1)
33 (9.1)
114 (31.2)
17 (4.7)
   Constipation
157 (43.1)
6 (1.6)
137 (37.5)
2 (0.5)
   Peripheral edema
155 (42.6)
10 (2.7)
117 (32.1)
3 (0.8)
   Back pain
155 (42.6)
14 (3.8)
109 (29.9)
14 (3.8)
   Asthenia
136 (37.4)
19 (5.2)
101 (27.7)
18 (4.9)
   Nausea
133 (36.5)
7 (1.9)
88 (24.1)
2 (0.5)
   Insomnia
125 (34.3)
11 (3.0)
116 (31.8)
14 (3.8)
   Bronchitis
124 (34.1)
12 (3.3)
87 (23.8)
7 (1.9)
   Cough
123 (33.8)
2 (0.5)
65 (17.8)
0 (0.0)
   Dyspnea
119 (32.7)
12 (3.3)
63 (17.3)
4 (1.1)
   Pneumonia
113 (31.0)
71 (19.5)
66 (18.1)
39 (10.7)
   Weight decreased
112 (30.8)
10 (2.7)
69 (18.9)
11 (3.0)
   Peripheral sensory neuropathy
111 (30.5)
9 (2.5)
66 (18.1)
2 (0.5)
   Muscle spasms
111 (30.5)
2 (0.5)
86 (23.6)
5 (1.4)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; Rd, lenalidomide + dexamethasone; TEAE, treatment-emergent adverse event.
aAny-grade TEAEs that are listed are those that occurred in ≥30% of patients in either group.

Final Survival Analysis of the MAIA Study

Facon et al (2024)4 presented the updated OS results for the D-Rd vs Rd arm at a long-term median follow-up of around 7.5 years.

Results

Patient Characteristics
Efficacy
  • At a median follow-up of 89.3 months (range, 0-102.2), the 7-year OS rate was 53.1% for the D-Rd arm and 39.3% for the Rd arm.
  • Median OS was reached for the D-Rd group and was prolonged for patients in the D-Rd vs Rd arm (90.3 vs 64.1 months [HR, 0.67; 95% CI, 0.55-0.82; nominal P<0.0001]). See Table: Analysis of OS in Prespecified Patient Subgroups.
  • Median time to subsequent antimyeloma therapy was 42.4 months in the Rd arm and NR in the D-Rd arm (HR, 0.51; 95% CI, 0.41-0.63; nominal P<0.0001). See Table: Summary of First Subsequent Antimyeloma Therapy in the Safety Population.
    • In the D-Rd vs Rd arm, 10.7% (15/140) vs 24.4% (49/201) of patients received DARZALEX-containing regimens as their first subsequent therapy.
    • Among treated patients, 38.5% (140/364) vs 55.1% (201/365) of patients in the D-Rd vs Rd arm received ≥1 subsequent antimyeloma therapy.
    • Across subsequent therapy lines, the most common antineoplastic agents in the D-Rd vs Rd arms were bortezomib (27.7% vs 41.9%), DARZALEX (6.3% vs 28.8%), and carfilzomib (7.7% vs 12.3%).
    • In patients evaluable for best response to first subsequent antimyeloma therapy, ≥CR was achieved by 4.6% (6/130) vs 4.1% (8/193) in the D-Rd vs Rd arm, and ≥VGPR was achieved by 13.8% (18/130) vs 23.8% (46/193) of patients in the D-Rd vs Rd arm.
    • No patient in either group reported the use of B-cell maturation antigen (BCMA)- or G protein–coupled receptor class C group 5 member D (GPRC5D)-targeted therapy.
    • Investigational drug was given to 2 patients in the D-Rd group and 2 patients in the Rd group in subsequent therapy lines.

Analysis of OS in Prespecified Patient Subgroupsa,4
Subgroup
D-Rd
Rd
HR (95% CI)b
n/N
Median OS, Months
n/N
Median OS, Months
Sex
   Male
95/189
82.5
120/195
60.6
0.72 (0.55-0.94)
   Female
80/179
NE
98/174
67.8
0.66 (0.49-0.89)
Age
   <75 years
84/208
NE
107/208
79.6
0.69 (0.52-0.92)
   ≥75 years
91/160
72.3
111/161
54.8
0.67 (0.51-0.88)
Race
   White
161/336
92.7
197/339
65.5
0.71 (0.57-0.87)
   Other
14/32
90.3
21/30
49.1
0.50 (0.25-0.99)
Region
   North America
46/101
92.7
64/102
54.8
0.57 (0.39-0.83)
   Other
129/267
90.3
154/267
66.8
0.74 (0.58-0.93)
Baseline renal function (CrCl)
   >60 mL/min
99/206
92.7
123/227
69.9
0.78 (0.60-1.01)
   ≤60 mL/min
76/162
90.3
95/142
54.4
0.57 (0.42-0.77)
Baseline hepatic function
   Normal
156/335
NE
203/340
63.8
0.65 (0.53-0.80)
   Impaired
19/31
63.5
15/29
87.4
1.31 (0.66-2.58)
ISS disease stage
   I
34/98
NE
42/103
NE
0.79 (0.50-1.24)
   II
77/163
92.7
95/156
61.7
0.63 (0.46-0.85)
   III
64/107
65.2
81/110
47.3
0.68 (0.49-0.95)
Type of MM
   IgG
111/225
87.2
132/231
69.3
0.78 (0.60-1.00)
   Non-IgG
35/74
86.4
49/76
53.7
0.58 (0.37-0.89)
Cytogenetic risk at study entryc
   High risk
31/48
55.6
36/44
42.5
0.65 (0.40-1.06)
   Standard risk
122/271
NE
160/279
65.5
0.66 (0.52-0.84)
ECOG PS
   0
48/127
NE
56/123
NE
0.76 (0.52-1.12)
   1
86/178
92.7
118/187
58.3
0.64 (0.48-0.84)
   ≥2
41/63
62.8
44/59
39.0
0.68 (0.44-1.04)
Abbreviations: CI, confidence interval; CrCl, creatinine clearance; D-Rd, DARZALEX + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; IgG, immunoglobulin G; ISS, International Staging System; MM, multiple myeloma; NE, not estimable; OS, overall survival; Rd, lenalidomide + dexamethasone.
aIn the ITT population, which included all randomized patients.
bHR and 95% CI from a Cox proportional hazards model with treatment as the sole explanatory variable. HR <1 indicates an advantage for D-Rd.
cCytogenetic risk was based on fluorescence in situ hybridization or karyotype analysis; patients who had a high-risk cytogenetic profile had ≥1 of the following high-risk abnormalities: del(17p), t(14;16), or t(4;14).

Summary of First Subsequent Antimyeloma Therapy in the Safety Populationa,4
n (%)
D-Rd
(n=140)
Rd
(n=201)
First subsequent therapy classb,c
   PI only
69 (49.3)
101 (50.2)
   IMiD only
22 (15.7)
25 (12.4)
   PI + IMiD
25 (17.9)
16 (8.0)
   DARZALEX monotherapy or combination
15 (10.7)
49 (24.4)
   Other
9 (6.4)
10 (5.0)
Most common first subsequent therapy regimensb,d
   Bortezomib/cyclophosphamide/dexamethasone
19 (13.6)
29 (14.4)
   Bortezomib/dexamethasone
20 (14.3)
28 (13.9)
   Bortezomib/melphalan/prednisone
14 (10.0)
28 (13.9)
   DARZALEX/bortezomib/dexamethasone
4 (2.9)
27 (13.4)
   Lenalidomide/dexamethasone
13 (9.3)
16 (8.0)
   Bortezomib/pomalidomide/dexamethasone
9 (6.4)
3 (1.5)
   Bortezomib/lenalidomide/dexamethasone
8 (5.7)
3 (1.5)
   DARZALEX/lenalidomide/dexamethasone
4 (2.9)
6 (3.0)
   Pomalidomide/dexamethasone
2 (1.4)
6 (3.0)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; IMiD, immunomodulatory drugs; PI, proteasome inhibitor; Rd, lenalidomide + dexamethasone.
aThe safety population included all randomized patients who received ≥1 dose of study treatment.
bPercentages were calculated with the number of patients who received subsequent therapy in each treatment group as the denominator.
cTherapy classes are mutually exclusive. Patients in any therapy class subgroup may have received additional agents (other than PI, IMiD, or DARZALEX), such as dexamethasone.
dRegimens received by ≥3% of patients in either treatment group.
Safety and Tolerability
  • Among the safety population, 78.3% (n=285) of patients in the D-Rd arm and 94.5% (n=345) in the Rd arm discontinued study treatment.
    • Progressive disease was the primary reason for discontinuation in both the D-Rd (32.7%) and Rd arms (38.6%).
    • A lower proportion of patients in the D-Rd (16.5%) and Rd arms (25.8%) discontinued study treatment due to AEs.
  • In the D-Rd vs Rd arm, 33% reduction in the risk of death was reported.

Summary of Death and Causes of Death in the Safety Populationa,4
n (%)
D-Rd
(n=364)
Rd
(n=365)
Total number of patients who died during the study
173 (47.5)
218 (59.7)
   Primary cause of death
      Disease progression
76 (20.9)
88 (24.1)
      Adverse events
44 (12.1)
40 (11.0)
         Related to study treatmentb
14 (3.8)
10 (2.7)
         Unrelated to study treatment
28 (7.7)
29 (7.9)
         Othersc
53 (14.6)
90 (24.7)
         Infections/infestations
9 (2.5)
30 (8.2)
         General disorders/administration site conditionsd
11 (3.0)
5 (1.4)
         Neoplasms (benign, malignant, or unspecified)
11 (3.0)
4 (1.1)
         Cardiac disorders
1 (0.3)
8 (2.2)
         Nervous system disorders
3 (0.8)
5 (1.4)
         Unknown
13 (3.6)
27 (7.4)
Deaths within 30 days of last study treatment dose
31 (8.5)
35 (9.6)
   Primary cause of death
      Disease progression
1 (0.3)
1 (0.3)
      Adverse events
29 (8.0)
32 (8.8)
         Related to study treatmentb
11 (3.0)
10 (2.7)
         Unrelated to study treatment
18 (4.9)
22 (6.0)
         Othere
1 (0.3)
2 (0.5)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; Rd, lenalidomide/dexamethasone.aThe safety population included all randomized patients who received ≥1 dose of study treatment.bAdverse events were related to ≥1 of the 3 components of study treatment: DARZALEX, lenalidomide, and dexamethasone.
cOther reasons were reported in ≥1% of patients in either treatment group.
dAll events were related to the general health condition of the patient.
eIncludes a nervous system disorder in 1 patient in the D-Rd group and a blood and lymphatic system disorder and general disorder/administration site condition in 1 patient each in the Rd group.

DARZALEX in Combination with Lenalidomide and Dexamethasone in Patients with RRMM

POLLUX (MMY3003; NCT02076009) is a phase 3, randomized, open-label, multicenter study to evaluate the safety and efficacy of D-Rd and Rd in patients with RRMM (N=569).13 Dimopoulos et al (2023)14 reported updated results of the POLLUX study, including OS, at a median follow-up of 79.7 months.

Results

Patients and Treatments

Baseline Demographics and Clinical Characteristics (POLLUX; ITT Population)14
Characteristic
D-Rd
(n=286)
Rd
(n=283)
Age, years
   Median (range)
65 (34-89)
65 (42-87)
   ≥75, n (%)
29 (10.1)
35 (12.4)
ISS staginga, n (%)
   I
137 (47.9)
140 (49.5)
   II
93 (32.5)
86 (30.4)
   III
56 (19.6)
57 (20.1)
Median (range) time from diagnosis, years
3.48 (0.4-27.0)
3.95 (0.4-21.7)
Prior lines of therapy, n (%)
   Median (range)
1 (1-11)
1 (1-8)
   1
149 (52.1)
146 (51.6)
   2
85 (29.7)
80 (28.3)
   3
38 (13.3)
38 (13.4)
   >3
14 (4.9)
19 (6.7)
Prior IMiD, n (%)
158 (55.2)
156 (55.1)
   Prior thalidomide
122 (42.7)
125 (44.2)
   Prior lenalidomide
50 (17.5)
50 (17.7)
Prior PI, n (%)
245 (85.7)
242 (85.5)
   Prior bortezomib
241 (84.3)
238 (84.1)
Prior PI+ IMiD, n (%)
125 (43.7)
125 (44.2)
Refractory to bortezomib, n (%)
59 (20.6)
58 (20.5)
Refractory to last line of prior therapy, n (%)
80 (28)
76 (26.9)
Cytogenetic risk profileb, n/N (%)
   Standard risk
193/228 (84.6)
176/211 (83.4)
   High risk
35/228 (15.4)
35/211 (16.6)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; IMiD, immunomodulatory drug; ISS, International Staging System; ITT, intention-to-treat; PI, proteasome inhibitor; Rd, lenalidomide + dexamethasone.
aISS staging was based on the combination of serum β2-microglobulin and albumin.
bCytogenetic risk was assessed locally by fluorescence in situ hybridization or karyotype testing; high risk was defined as the presence of t(4;14), t(14;16), or del17p abnormality.
Efficacy
  • At a median follow-up of 79.7 months, D-Rd arm provided a 27% reduction in the risk of death compared to Rd arm (HR, 0.73; 95% CI, 0.58-0.91; P=0.0044).
    • Median OS in the ITT population with D-Rd was 67.6 months (95% CI, 53.1-80.5) vs 51.8 months (95% CI, 44.0-60.0) with Rd.
  • MRD-negativity rate at a 10-5 sensitivity threshold was 33.2% vs 6.7% in the D-Rd vs Rd arms, respectively (P<0.0001).
  • In the ITT population, median disease progression on the next line of therapy or death (PFS2) was significantly prolonged in D-Rd vs Rd arms, respectively, at 57.9 months vs 32.0 months (HR, 0.54; 95% CI, 0.43-0.67; P<0.0001).
  • In total, 44.9% (127 of 283) of patients vs 74.7% (210 of 281) of patients in the D-Rd vs Rd arms, respectively, received subsequent therapy. See Table: Most Common Subsequent Anticancer Therapies in the D-Rd and Rd arms.
    • Of the patients in the Rd arm who received subsequent therapy, 122 (58.1%) patients received DARZALEX in any subsequent line of therapy.
    • Median number of subsequent lines of therapy was 2 (range, 1-13) vs 2 (range, 1-12) in the D-Rd vs Rd arms, respectively.
  • Median time to subsequent treatment was significantly increased with D-Rd vs Rd (69.3 vs 23.1 months; HR, 0.40; 95% CI, 0.32-0.50; P<0.0001).
  • The most common first line subsequent anticancer therapy was pomalidomide and dexamethasone (12.5%) or bortezomib and dexamethasone (10.2%) in the D-Rd arm and DARZALEX monotherapy (22.4%) in the Rd arm.

Most Common Subsequent Anticancer Therapies in the D-Rd and Rd arms14
Drug, %
D-Rd
Rd
Dexamethasone
39.2
63.0
Daratumumab
-
43.4
Pomalidomide
23.7
37.0
Bortezomib
19.8
33.8
Cyclophosphamide
17.7
38.1
Carfilzomib
16.6
23.5
Lenalidomide
-
18.5
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; Rd, lenalidomide + dexamethasone.
Safety

Most Common (>15% of Patients) and Grade 3/4 (>5% of Patients) TEAEs in the Safety Population14
TEAE, n (%)
All Grades
Grade 3/4
D-Rd
(n=283)
Rd
(n=281)
D-Rd
(n=283)
Rd
(n=281)
Hematologic
   Neutropenia
185 (65.4)
136 (48.4)
163 (57.6)
117 (41.6)
   Anemia
121 (42.8)
117 (41.6)
56 (19.8)
63 (22.4)
   Thrombocytopenia
93 (32.9)
90 (32.0)
44 (15.5)
44 (15.7)
   Lymphopenia
20 (7.1)
17 (6.0)
17 (6.0)
12 (4.3)
   Febrile neutropenia
18 (6.4)
8 (2.8)
18 (6.4)
8 (2.8)
Nonhematologic
   Diarrhea
170 (60.1)
108 (38.4)
29 (10.2)
11 (3.9)
   URIT
125 (44.2)
79 (28.1)
6 (2.1)
5 (1.8)
   Fatigue
119 (42.0)
87 (31.0)
20 (7.1)
12 (4.3)
   Cough
107 (37.8)
43 (15.3)
1 (0.4)
0 (0.0)
   Nasopharyngitis
100 (35.3)
62 (22.1)
0 (0.0)
0 (0.0)
   Constipation
95 (33.6)
77 (27.4)
4 (1.4)
2 (0.7)
   Muscle spasms
87 (30.7)
61 (21.7)
3 (1.1)
5 (1.8)
   Nausea
87 (30.7)
53 (18.9)
6 (2.1)
2 (0.7)
   Insomnia
80 (28.3)
65 (23.1)
6 (2.1)
6 (2.1)
   Pneumonia
80 (28.3)
49 (17.4)
49 (17.3)
31 (11)
   Back pain
77 (27.2)
59 (21.0)
10 (3.5)
5 (1.8)
   Pyrexia
77 (27.2)
41 (14.6)
9 (3.2)
7 (2.5)
   Arthralgia
75 (26.5)
56 (19.9)
4 (1.4)
4 (1.4)
   Peripheral edema
72 (25.4)
50 (17.8)
3 (1.1)
4 (1.4)
   Dyspnea
67 (23.7)
39 (13.9)
15 (5.3)
2 (0.7)
   Vomiting
66 (23.3)
20 (7.1)
3 (1.1)
4 (1.4)
   Bronchitis
63 (22.3)
50 (17.8)
9 (3.2)
9 (3.2)
   Cataract
61 (21.6)
35 (12.5)
21 (7.4)
13 (4.6)
   Asthenia
59 (20.8)
47 (16.7)
10 (3.5)
9 (3.2)
   Hypokalemia
58 (20.5)
35 (12.5)
19 (6.7)
12 (4.3)
   Headache
57 (20.1)
23 (8.2)
0 (0.0)
0 (0.0)
   Rash
51 (18.0)
36 (12.8)
1 (0.4)
0 (0.0)
   Decreased appetite
50 (17.7)
37 (13.2)
6 (2.1)
1 (0.4)
   Pain in extremity
48 (17.0)
42 (14.9)
0 (0.0)
1 (0.4)
   Influenza
46 (16.3)
24 (8.5)
11 (3.9)
3 (1.1)
   Hypophosphatemia
22 (7.8)
14 (5.0)
16 (5.7)
8 (2.8)
   Syncope
16 (5.7)
4 (1.4)
15 (5.3)
4 (1.4)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; Rd, lenalidomide + dexamethasone; TEAE, treatment-emergent adverse event; URTI, Upper respiratory tract infection.

TEAEs Leading to Treatment Discontinuation or Deaths14
TEAEs
D-Rd
(n=283)
Rd
(n=281)
Serious TEAEs, %
72.4
52.7
   Pneumonia
17.0
11.4
TEAEs leading to treatment discontinuation, %
19.1
16.0
   Infections, n (%)
13 (4.6)
11 (3.9)
TEAEs leading to death, n (%)
35 (12.4)
24 (8.5)
   Septic shock, %
1.4
0.4
   Cardiac arrest, %
1.1
0.4
   Sudden death, %
1.1
0.4
   Pneumonia, %
0.7
1.1
   Acute kidney injury, %
0.4
1.1
   Sepsis, %
0
1.1
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; Rd, lenalidomide + dexamethasone; TEAE, treatment-emergent adverse event.

DARZALEX FASPRO in Combination with 4 Standard-of-Care Regimens

PLEIADES (MMY2040; NCT03412565) is an ongoing, phase 2, non-randomized, open-label, multicenter study evaluating the clinical benefit of DARZALEX FASPRO administered in combination with various treatment regimens in patients with MM. Chari et al (2021)24 presented updated safety and efficacy results for DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd), DARZALEX FASPRO in combination with bortezomib, melphalan, and prednisone (D-VMP), and D-Rd arms of the PLEIADES study. Results specific to the D-Rd arm at a median follow-up of 14.7 months are summarized below. Moreau et al (2020)25 presented updated safety and efficacy results for DARZALEX FASPRO in combination with carfilzomib and dexamethasone (D-Kd; primary analysis), D-Rd, and D-VMP arms of the PLEIADES study. Results specific to the D-Rd arm at a median follow up of 25.7 months are summarized below.

Results: D-Rd Cohort at a Median Follow-up of 14.7 Months

Patient Characteristics and Disposition

Baseline Demographics and Patient Characteristics - D-Rd Cohorta,24
RRMM With ≥ 1 Prior Line of Therapy
D-Rd (n=65)
Age, years
   Median (range)
69 (33-82)
   18 to <65, n (%)
22 (33.8)
   65 to <75, n (%)
29 (44.6)
   ≥75, n (%)
14 (21.5)
Male, n (%)
45 (69.2)
Median (range) body weight, kg
80.6 (54-143)
Race, n (%)
   White
45 (69.2)
   Black or African American
2 (3.1)
   Asian
0 (0.0)
ECOG PS score, n (%)
   0
36 (55.4)
   1
29 (44.6)
   2
0 (0.0)
Median (range) number of prior lines of therapy, n
1 (1-5)
ISS stagingb, n (%)
   I
27 (41.5)
   II
19 (29.2)
   III
18 (27.7)
Cytogenic riskc, d, n (%)
n=31
   Standard risk
20 (64.5)
   High risk
11 (35.5)
   t(4;14)
6 (19.4)
   t(14;16)
3 (9.7)
   del17p
4 (12.9)
Abbreviations: D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, international staging system; RRMM, relapsed or refractory multiple myeloma.
aAll-treated population, defined as patients who received ≥1 dose of study treatment.
bBased on the combination of serum β2-microglobulin and albumin at screening.
cBased on fluorescence in situ hybridization or karyotyping testing conducted locally.
dHigh cytogenetic risk was defined as having ≥1 of t(4;14), t(14;16) or del17p abnormalities.

Patient Disposition and Exposure - D-Rd Cohorta, 24
RRMM With ≥ 1 Prior Line of Therapy
D-Rd (n=65)
Median (range) number of treatment cycles
16 (1-19)
Median (range) duration of treatment, months
14.9 (0-17)
Relative dose intensity, median %
   DARZALEX FASPRO
100
   Bortezomib
-
   Melphalan
-
   Prednisone
-
   Lenalidomide
82
   Dexamethasone
65.6
Abbreviations: D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; RRMM, relapsed or refractory multiple myeloma.
aThe all-treatedpopulation included all patients who received ≥1 dose of study treatment.
Efficacy
  • Median follow-up was 14.7 months for D-Rd cohort.24
  • Primary endpoints were met for the D-Rd cohort with available data and response rates similar to the DARZALEX study, POLLUX.30
    • In the D-Rd cohort:
      • ORR was 93.8% vs 92.9% in the POLLUX study.
      • VGPR was 40% vs 32.7%.
      • PR was 15.4% vs 17.1%.
      • CR was 20% vs 24.9%.
      • Stringent complete response (sCR) was 18.5% vs 18.1%.
  • MRD-negativity rates were evaluated via next-generation sequencing (NGS) at a sensitivity threshold of 10-5.24
    • MRD-negativity rate was 15.4% (90% CI, 8.6-24.7) in the D-Rd cohort.  
Safety
  • Treatment discontinuation due to TEAEs were 8% in the D-Rd cohort.24
  • A summary of TEAEs in each cohort is presented in Table: Safety Summary - D-Rd Cohort.24
  • Any-grade infusion-related reactions (IRRs) occurred in 8% of patient across all cohorts.24

Safety Summary - D-Rd Cohort24
n (%)
RRMM With ≥ 1 Prior Line of Therapy
D-Rd (n=65)
Any TEAE
65 (100)
Serious TEAE
34 (52.3)
Grade 3/4 TEAE
58 (89.2)
Grade 5
2 (3.1)
TEAEs leading to treatment discontinuation
5 (7.7)
Abbreviations: D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; RRMM, relapsed or refractory multiple myeloma; TEAE, treatment-emergent adverse event.
  • Across all 3 cohorts with available data any grade IRRs occurred in 8% (15/199) of patients.24
    • IRRs were mild (grade 1/2), one patient had grade 3 IRR and no patients reported grade 4 IRR.
  • Median time to onset of IRRs was 5.5 hours in the D-Rd cohorts.24
  • Local injection site reactions occurred in 8% of patients in all cohorts (all grade 1/2).24
  • A summary of most common TEAEs is presented in Table: Most Common TEAEs in D-Rd Cohort (≥ 5%).24

Most Common TEAEs in D-Rd Cohort (≥5%)24
Event, n (%)
RRMM With ≥ 1 Prior Line of Therapy
D-Rd (n=65)
Hematologic
   Neutropenia
32 (49.2)
   Lymphopenia
7 (10.8)
   Thrombocytopenia
9 (13.8)
   Leukopenia
6 (9.2)
   Anemia
6 (9.2)
Nonhematologic
   Pneumonia
8 (12.3)
   Hypertension
1 (1.5)
   Hyperglycemia
6 (9.2)
   Hypokalemia
4 (6.2)
Any-grade IRR
3 (4.6)
Abbreviations: D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; IRR, infusion-related reaction; RRMM, relapsed or refractory multiple myeloma; TEAE, treatment-emergent adverse event.

Results: D-Rd Cohort at a Median Follow-up of 25.7 Months

Patient Characteristics and Disposition

Baseline Demographics and Patient Characteristics - D-Rd Cohorta, 25
RRMM With ≥1 Prior Line of Therapy
D-Rd (n=65)
Time since initial diagnosis, median (range), months
35.0 (3.6-384.5)
Prior ASCT, n (%)
34 (52)
   Last prior line of therapy
20 (31)
   PI and IMiD
1 (2)
   Lenalidomide
-
Bone marrow % plasma cells, n (%)
   N
65
      <10
15 (23)
      10-30
28 (43)
      >30
22 (34)
Abbreviations: ASCT, autologous stem cell transplantation; D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; IMiD, immunomodulatory drug; PI, proteasome inhibitor; RRMM, relapsed or refractory multiple myeloma.
aAll-treated population, defined as patients who received ≥1 dose of study treatment.
bBased on the combination of serum β2-microglobulin and albumin.
cBased on fluorescence in situ hybridization/karyotype testing.

Patient Disposition - D-Rd Cohorta,25
n (%)
RRMM With ≥1 Prior Line of Therapy
D-Rd (n=65)
Patients who are still on treatment
41 (63)
Patients who discontinued treatment
24 (37)
Reason for discontinuation
   Progressive disease
13 (20)
   Patient withdrawal
2 (3)
   Death
1 (2)
   Adverse event
7 (11)
   Other
0 (0)
   Protocol deviation
1 (2)
   Physician decision
0 (0)
Abbreviations: D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; RRMM, relapsed or refractory multiple myeloma.
aAll-treated population, defined as patients who received ≥1 dose of study treatment.

Patient Drug Exposure - D-Rd Cohorta,25
RRMM With ≥1 Prior line of Therapy
D-Rd (n=65)
Median (range) number of treatment cycles
27.0 (1-31)
Median (range) duration of treatment, months
25.6 (0-28)
Relative dose intensity, median %
   Daratumumab
100.0
   Carfilzomib
-
   Dexamethasoneb
59.7
   Lenalidomide
77.8
   Bortezomib
-
   Melphalan
-
   Prednisone
-
Abbreviations: COVID-19, coronavirus disease 2019; D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; RRMM, relapsed or refractory multiple myeloma.
aAll-treated population, defined as patients who received ≥1 dose of study treatment.
bDexamethasone dose intensity was affected by dose modifications due to the COVID-19 pandemic.
Efficacy
  • Median duration of follow-up was 25.7 months for D-Rd cohort.25
  • Response rates were similar to DARZALEX studies in POLLUX.30
    • In the D-Rd cohort (n=65):
      • ORR was 93.8% vs 92.9% in the POLLUX study.30
      • sCR was 23.1% vs 29.5%.
      • CR was 26.2% vs 28.1%.
      • VGPR was 30.8% vs 23.5%.
      • PR was 13.8% vs 11.7%.
  • MRD-negativity rates were evaluated via NGS at a sensitivity threshold of 10-5.25
    • MRD-negativity rate was 20.0% in the D-Rd cohort.
    • MRD-negative ≥CR rate was 20.0% in the D-Rd cohort.
Safety
  • A summary of TEAEs reported is presented in Table: Summary of TEAEs in D-Rd Cohort.25
  • Cardiac toxicities were infrequent (<5%) in D-Rd cohort.25
  • Most patients with IRRs experienced them on the first administration (D-Rd, 100%).
  • IRRs were mild (grade 1/2).25
  • Median (range) time to onset of IRRs was 330 (254-330) minutes in the D-Rd cohort.25
  • Local injection site reactions occurred in 6% (11/198) of patients (all grade 1/2).25

Summary of TEAEs in D-Rd Cohorta,25
n (%)
RRMM With ≥1 Prior Line of Therapy
D-Rd (n=65)
Any-grade TEAE
65 (100)
Grade 3/4 TEAE
61 (94)
   Most common hematologic TEAEs (≥5% in any cohort)
      Thrombocytopenia
9 (14)
      Lymphopenia
7 (11)
      Anemia
6 (9)
      Neutropenia
36 (55)
      Leukopenia
6 (9)
   Most common nonhematologic TEAEs (≥5% in any cohort)
      Hypertension
8 (12)
      Insomnia
3 (5)
      Pneumonia
10 (15)
      Hyperglycemia
6 (9)
      Hypokalemia
4 (6)
      Diarrhea
4 (6)
      Lower respiratory tract infection
4 (6)
Grade 5 TEAE
2 (3)
Serious TEAEs
36 (55)
TEAEs leading to treatment discontinuationb
6 (9)
Any-grade IRR
3 (5)
Abbreviations: D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; IRR, infusion-related reaction; RRMM, relapsed or refractory multiple myeloma; TEAE, treatment-emergent adverse event.
aAll-treated population, defined as patients who received ≥1 dose of study treatment.
bPneumonia (n=2), diverticulitis (n=1), enterobacter infection (n=1), myocardial infarction (n=1), and face edema (n=1).

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 09 September 2025. For purposes of streamlining, this scientific response has been limited to phase 2/3 clinical studies.

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

 

References

Show
1 Facon T, Kumar S, Plesner T, et al. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med. 2019;380(22):2104-2115.  
2 Facon T, Kumar SK, Plesner T, et al. Phase 3 randomized study of daratumumab plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) in patients with newly diagnosed multiple myeloma (NDMM) ineligible for transplant (MAIA). Oral presentation presented at: 60th American Society of Hematology (ASH) Annual Meeting & Exposition; December 1-4, 2018; San Diego, CA.  
3 Facon T, Moreau P, Weisel K, et al. Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes. Leukemia. 2025;39(4):942-950.  
4 Facon T, Kumar SK, Orlowski R, et al. Final survival analysis of daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma: MAIA study. Poster presented at: The European Hematology Association (EHA) Hybrid Congress; June 13-16, 2024; Madrid, Spain.  
5 Facon T, Kumar S, Weisel K, et al. Daratumumab plus lenalidomide and dexamethasone in patients with transplant-ineligible newly diagnosed multiple myeloma: MAIA age subgroup analysis. 2022;(Poster).  
6 Moreau P, Facon T, Usmani S, et al. Daratumumab plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): clinical assessment of key subgroups of the phase 3 MAIA study. 2022;(Poster).  
7 Facon T, Kumar S, Plesner T, et al. Time to response, duration of response, and patient-reported outcomes (PROs) with daratumumab (DARA) plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of the phase 3 MAIA study. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2022; Chicago, IL/Virtual Meeting.  
8 Facon T, Cook G, Usmani SZ, et al. Daratumumab plus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: frailty subgroup analysis of MAIA. Leukemia. 2022;36(4):1066-1077.  
9 San-Miguel J, Avet-Loiseau H, Paiva B, et al. Sustained minimal residual disease negativity with daratumumab in newly diagnosed multiple myeloma: MAIA and ALCYONE. Blood. 2022;139:492-501.  
10 Jakubowiak AJ, Kumar S, Medhekar R, et al. Daratumumab Improves Depth of Response and Progression-free Survival in Transplant-ineligible, High-risk, Newly Diagnosed Multiple Myeloma. Oncol. 2022;27(7):oyac067-.  
11 Facon T, Plesner T, Usmani S, et al. Health-related quality of life for frail transplant-ineligible patients with newly diagnosed multiple myeloma treated with daratumumab, lenalidomide and dexamethasone: subgroup analysis of MAIA trial. Poster presented at: 4th European Myeloma Network (EMN) Meeting; April 20-22, 2023; Amsterdam.  
12 Moreau P, Facon T, Usmani SZ, et al. Daratumumab plus lenalidomide/dexamethasone in untreated multiple myeloma: analysis of key subgroups of the MAIA study. Leukemia. 2025;39(3):710-719.  
13 Dimopoulos M, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331.  
14 Dimopoulos MA, Oriol A, Nahi H, et al. Overall survival with daratumumab, lenalidomide, and dexamethasone in previously treated multiple myeloma (POLLUX): a randomized, open-label, phase III trial. J Clin Oncol. 2023;41(8):1590-1599.  
15 Spencer A, Moreau P, Mateos M, et al. Daratumumab in combination with bortezomib plus dexamethasone (D-Vd) or lenalidomide plus dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analysis of the phase 3 CASTOR and POLLUX studies in patients with early or late relapse after initial therapy. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2022; Chicago, IL/Virtual Meeting.  
16 Mateos M, Richardson P, Weisel K, et al. Daratumumab (DARA) plus bortezomib and dexamethasone (D-Vd) or lenalidomide and dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analyses of CASTOR and POLLUX. 2022;(Poster).  
17 Plesner T, Dimopoulos M, Oriol A, et al. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial. Br J Haematol. 2021;194:132-139.  
18 Kaufman J, Dimopoulos M, White D, et al. Daratumumab, lenalidomide, and dexamethasone in relapsed/refractory myeloma: a cytogenetic subgroup analysis of POLLUX. Blood Cancer J. 2020;10(11):111.  
19 Usmani S, Mateos M, Lentzsch S, et al. Efficacy of daratumumab in combination with standard-of-care regimens in lenalidomide-exposed or -refractory patients with relapsed/refractory multiple myeloma (RRMM): analysis of the CASTOR, POLLUX, and MMY1001 studies. Poster presented at: 60th American Society of Hematology (ASH) Annual Meeting & Exposition Poster; December 1-4, 2018; San Diego, CA.  
20 Spencer A, Moreau P, Mateos MV, et al. Daratumumab for patients with myeloma with early or late relapse after initial therapy: subgroup analysis of CASTOR and POLLUX. Blood Advances. 2024;8(2):388-398.  
21 H SMJCA Goldschmidt. Subcutaneous (SC) daratumumab (DARA) in combination with standard multiple myeloma (MM) treatment regimens: an open-label, multicenter phase 2 study (PLEIADES). 2019.  
22 Chari A, Goldschmidt H, Yang S, et al. Subcutaneous daratumumab plus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma: an open-label, multicenter, phase 2 study (PLEIADES). Poster presented at: 17th International Myeloma Workshop (IMW); September 12-15, 2019; Boston, MA.  
23 Chari A, Miguel J, McCarthy H, et al. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy: PLEIADES study update. Poster presented at: 61st American Society of Hematology (ASH) Annual Meeting; December 7-10, 2019; Orlando, FL.  
24 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.  
25 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: 62nd American Society of Hematology (ASH) Annual Meeting & Exposition; December 5-8, 2020; Virtual.  
26 Wang J, Arroyo-Suarez R, Dasari S, et al. Early versus late response to daratumumab-based triplet therapies in patients with multiple myeloma: a pooled analysis of trials POLLUX, CASTOR and MAIA. Leuk Lymphoma. 2022;63(7):1669-1677.  
27 Perrot A, Facon T, Plesner T, et al. Sustained improvement in health‐related quality of life in transplant‐ineligible newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, and dexamethasone: MAIA final analysis of patient‐reported outcomes. Eur J Haematol. 2025;114(5):883-889.  
28 Facon T, Kumar S, Plesner T, et al. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(11):1582-1596.  
29 Facon T, Moreau P, Weisel K, et al. Supplement to: Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes. Leukemia. 2025;39(4):942-950.  
30 Kaufman JL, Usmani S, Miguel J, et al. Four-year follow-up of the phase 3 POLLUX study of daratumumab plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) alone in relapsed or refractory multiple myeloma (RRMM). Poster presented at: 61st American Society of Hematology (ASH) Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL.