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(daratumumab)

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DARZALEX® (daratumumab)
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DARZALEX + DARZALEX FASPRO - Use in Extramedullary Disease

Last Updated: 06/24/2026

SUMMARY

  • DARZALEX for intravenous (IV) use and DARZALEX FASPRO for subcutaneous (SC) use are not approved by the regulatory agencies for use in patients with extramedullary disease (EMD). Johnson & Johnson does not recommend the use of DARZALEX or DARZALEX FASPRO in a manner that is inconsistent with the approved labeling.
  • MAIA is a phase 3 study evaluating the efficacy and safety of DARZALEX in combination with lenalidomide and dexamethasone (D-Rd) compared with lenalidomide and dexamethasone (Rd) in transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM). At a median follow-up of 64.5 months, the median progression-free survival (PFS) was 57.5 months in the D-Rd arm and 19.4 months in the Rd arm of the extramedullary plasmacytoma subgroup.1,2
  • SIRIUS is a phase 2 study evaluating the efficacy and safety of DARZALEX monotherapy in patients with multiple myeloma (MM) who received ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or had disease refractory to both a PI and an immunomodulatory agent. At baseline, there were 14 patients (13%) with ≥1 extramedullary plasmacytoma. The overall response rate (ORR) was 21.4% (n=3) in patients with extramedullary plasmacytoma (95% confidence interval [CI], 4.750.8).3
  • Beksac et al (2026)4 reported efficacy and safety results from the phase 2 EMN19 study evaluating DARZALEX in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) in patients with NDMM or first-relapse MM and confirmed EMD. Complete response or better (≥CR) was achieved by 47.5% of patients. The most common grade 3/4 treatment-emergent adverse events (TEAEs) were pneumonia (12.5%) and COVID-19 infection (7.5%).
  • Kumar et al (2024)5 presented results from a retrospective, descriptive analysis involving secondary use of historical data from 7 clinical trials in patients with relapsed/refractory multiple myeloma (RRMM) with and without EMD. Across the 7 trials, ORRs were numerically lower for patients with EMD vs patients without EMD (range, 0%-50.0% vs 42.7-92.8%, respectively). Over the first year of treatment, patients with EMD generally had higher rates of progression and/or death vs patients without EMD (range; progression: 33.3%-100% vs 14.8%-69.5%, respectively; death: 0%-66.7% vs 6.9%-29.2%, respectively).
  • Jelinek et al (2022)6 conducted a retrospective study to evaluate the efficacy of DARZALEX monotherapy and D-Rd in patients with RRMM and EMD. Of the 41 patients with RRMM who were administered DARZALEX monotherapy, 34% had EMD. In patients with EMD vs without EMD, the ORR was 21.4% vs 50.0%, median PFS was 1.4 months vs 6.2 months (P=0.002), and median overall survival (OS) was 4.6 months vs 15.4 months (P=0.042), respectively. Of the 186 patients with RRMM who were administered D-Rd, 22% had EMD. In patients with EMD vs without EMD, the ORR was 57.7% vs 84.5% (P=0.0048), and median PFS was 7.8 months vs 27.3 months (P=0.002), respectively.
  • Other relevant literature has been identified in addition to the data summarized above and is listed in the References section for your information.7-19  

PRODUCT LABELING

CLINICAL DATA

Phase 3 Study of DARZALEX in Combination with Rd in TIE NDMM

MAIA (MMY3008; NCT02252172) is a phase 3, international, randomized, open-label, active-controlled, multicenter study in patients with NDMM not eligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT).1

Study Design/Methods

  • Patients were randomized 1:1 to receive D-Rd or Rd until progressive disease (PD) or unacceptable toxicity.1
  • Efficacy and safety outcomes were evaluated in clinically important subgroups, including a subgroup of patients with extramedullary plasmacytomas.1
  • Primary endpoint: PFS.1
  • Key secondary endpoints: ORR, minimal residual disease (MRD)-negativity (10-5).1

Analysis of Clinically Important Subgroups of the MAIA Study

Moreau et al (2022)2 presented the efficacy and safety results in clinically important subgroups of patients from the MAIA study at a median follow-up of 64.5 months.

Results

Patient Characteristics
  • Overall, 737 patients (D-Rd, n=368; Rd, n=369) were included in the intent-to-treat (ITT) population, of whom 15 in the DRd arm and 9 in the Rd arm had extramedullary plasmacytomas.2
Efficacy
  • At data cut-off, 7 of 15 and 5 of 9 patients with extramedullary plasmacytomas in the DRd and Rd arm, respectively, were alive without progression. The median PFS was 57.5 months in the D-Rd arm and 19.4 months in the Rd arm of the extramedullary plasmacytoma subgroup (hazard ratio [HR], 0.47; 95% CI, 0.15-1.50).2
  • Other efficacy outcomes in the extramedullary plasmacytoma subgroup are summarized in Table: Efficacy Outcomes in Patients with Extramedullary Plasmacytoma.2

Efficacy Outcomes in Patients with Extramedullary Plasmacytoma2
Parameter
D-Rd
n/N (%)
Rd
n/N (%)
OR (95% CI)a
ORR
13/15 (86.7)
3/9 (33.3)
13.00 (1.70-99.37)
MRD-negativity (10-5)
5/15 (33.3)
0/9 (0)
NE (NE-NE)
Sustained MRD-negativity (10-5)
2/15 (13.3)
0/9 (0)
NE (NE-NE)
Abbreviations: CI, confidence interval; D-Rd, DARZALEX + lenalidomide + dexamethasone; MRD, minimal residual disease; NE, not evaluable; OR, odds ratio; Rd, lenalidomide + dexamethasone.
aOR >1 indicates an advantage for D-Rd.

Phase 2 Study of DARZALEX Monotherapy in Heavily Pretreated RRMM

SIRIUS (MMY2002; NCT01985126) is a phase 2, open-label, multicenter, international study evaluating the efficacy and safety of DARZALEX monotherapy in patients with MM who have received ≥3 prior lines of therapy including a PI and an immunomodulatory agent or have disease refractory to both a PI and an immunomodulatory agent.3

Study Design/Methods

  • Patients were initially randomized 1:1 to receive DARZALEX 8 mg/kg every 4 weeks; or DARZALEX 16 mg/kg every week for 8 weeks, DARZALEX 16 mg/kg every 2 weeks for 16 weeks, then DARZALEX 16 mg/kg every 4 weeks thereafter.3
  • Primary endpoint: ORR.3
  • Secondary endpoints: PFS, OS, duration of response (DOR).3

Primary Efficacy and Safety Analysis of the SIRIUS Study

Lonial et al (2016)3 evaluated the efficacy and safety of DARZALEX monotherapy in patients with MM (N=106) who were refractory to both a PI and an immunomodulatory agent.

Results

Patient Characteristics

Key Baseline Patient Demographics and Disease Characteristics3
Demographics, n (%)
DARZALEX 16 mg/kg
(N=106)
Age, years
   Median (range)
63.5 (31.0-84.0)
   18 to <65
58 (55)
   65 to <75
36 (34)
   ≥75
12 (11)
≥1 extramedullary plasmacytoma
14 (13)
Median time since initial diagnosis, years (range)
4.8 (1.1-23.8)
Efficacy

Overall Response Rate by Subgroup3
Subgroup
n/N (ORR %, 95% CI)
All patients
31/106 (29.2, 20.8-38.9)
Extramedullary plasmacytoma at baseline
   Yes
3/14 (21.4, 4.7-50.8)
   No
28/92 (30.4, 21.3-40.9)
Abbreviations: CI, confidence interval; ORR, overall response rate

Phase 2 Study Evaluating D-VCd in NDMM or First-Relapse MM with EMD

Beksac et al (2026)4 reported efficacy results from the EMN19 trial, a phase 2, open-label, single-arm, multinational study evaluating D-VCd in patients with NDMM or first-relapse MM and confirmed EMD.

Study Design/Methods

  • Key eligibility criteria: NDMM or first-relapsed MM with EMD, measurable disease, Eastern Cooperative Oncology Group performance status (ECOG PS) score 0-2.4
  • Key exclusion criteria: solitary plasmacytoma, previous therapy with anti-CD38 monoclonal antibody, refractory to bortezomib-based regimens.4
  • Patients received the following treatment until progression or unacceptable toxicity (maximum 36 months)4:
    • DARZALEX was given 16 mg/kg IV initially but was switched to DARZALEX FASPRO 1800 mg SC after July 2020, administered once a week (QW) during cycles 1-2, once every 2 weeks (Q2W) during cycles 3-6, and once every 4 weeks (Q4W) during cycles 7+.
    • Bortezomib 1.5 mg/m2 SC QW.
    • Cyclophosphamide 300 mg/m2 PO or IV QW.
    • Dexamethasone 20 mg PO or IV on days 1, 2, 8, 9, 15, 16, 22, and 23.
  • Treatment was discontinued if patients failed to achieve a confirmed partial response or better (≥PR) by the end of cycle 3.4
  • ASCT was permitted for patients who successfully completed 4-6 cycles of D-VCd.4
  • Primary endpoint: CR.4
  • Key secondary endpoints: ORR, PFS, OS, DOR, safety.4

Results

Patient Characteristics
  • Overall, 40 patients were enrolled, including 29 patients (72.5%) with NDMM and 11 patients (27.5%) with relapsed MM (RMM). Baseline patient and disease characteristics are summarized in Table: Baseline Patient and Disease Characteristics.4
  • The median follow-up was 30.0 months (range, 2.0-52.4).4
  • At data cut-off, the median D-VCd treatment duration was 18.4 months (range, 0.8-52.4) and 11/29 patients (37.9%) with NDMM received ASCT.4

Baseline Patient and Disease Characteristics4
Characteristic
Overall
(n=40)
First Relapsed
(n=11)
Newly Diagnosed
(n=29)
Median age (range)
58.0 (37.0-77.0)
58.0 (37.0-72.0)
58.0 (44.0-77.0)
Male, n (%)
22 (55.0)
5 (45.5)
17 (58.6)
ECOG PS, n (%)
   0
26 (56.0)
5 (45.5)
21 (72.4)
   1
12 (30.0)
5 (45.5)
7 (24.1)
   2
2 (5.0)
1 (9.1)
1 (3.4)
ISS stage, n (%)
   I
19 (47.5)
3 (27.3)
16 (55.2)
   II
14 (35.0)
6 (54.5)
8 (27.6)
   III
7 (17.5)
2 (18.2)
5 (17.2)
Extramedullary plasmacytoma by type, n (%)
   EMD
22 (55.0)
5 (45.5)
17 (58.6)
   PS
14 (35.0)
3 (27.3)
11 (37.9)
   EMD and PS
4 (10.0)
3 (27.3)
1 (3.4)
Extramedullary plasmacytoma by sitea, n (%)
   Thorax
12 (30.0)
3 (27.3)
9 (31.0)
   Vertebra
9 (22.5)
1 (9.1)
8 (27.6)
   Lymph node
6 (15.0)
1 (9.1)
5 (17.2)
   Skull
6 (15.0)
1 (9.1)
5 (17.2)
   Pleura
5 (12.5)
2 (18.2)
3 (10.3)
   Upper extremities
4 (10.0)
1 (9.1)
3 (10.3)
   Brain (cerebrospinal fluid)
4 (10.0)
1 (9.1)
3 (10.3)
   Intra-abdominal
4 (10.0)
2 (18.2)
2 (6.9)
   Lower extremities
4 (10.0)
1 (9.1)
3 (10.3)
   Upper respiratory tract
3 (7.5)
0
3 (10.3)
   Otherb
7 (17.5)
2 (18.2)
5 (17.2)
High-risk cytogenetics, n (%)
   Yes
6 (15.0)
2 (18.2)
4 (13.8)
   No
19 (47.5)
5 (45.5)
14 (48.3)
   Not reported
15 (37.5)
4 (36.4)
11 (37.9)
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; ISS, International Staging System; PS, paraskeletal.
aPatients could have more than one extramedullary plasmacytoma.
bOther sites included bony pelvis, breast, liver, lower respiratory tract, neck, and skin.
Efficacy
  • The ORR was 80.0% (NDMM, 89.7% [n=26/29]; RMM, 54.5% [n=6/11]).4
  • Best hematologic responses are summarized in Table: Treatment Responses.4

Treatment Responses4
Parameter
Overall
(n=40)
First Relapsed
(n=11)
Newly Diagnosed
(n=29)
Best hematologic response overall per IMWG, n (%)
   ≥CR
19 (47.5)
2 (18.2)
17 (58.6)
      sCR
3 (7.5)
1 (9.1)
2 (6.9)
      CR
16 (40.0)
1 (9.1)
15 (51.7)
      Time to ≥CR, months (range)
4.6 (1.0-15.2)
7.6 (3.1-12.2)
4.6 (1.0-15.2)
   ≥VGPR
30 (75.0)
6 (54.5)
24 (82.8)
      Time to ≥VGPR, months (range)
1.9 (0.9-10.4)
1.4 (0.9-2.3)
2.0 (1.0-10.4)
Best hematologic response without/before ASCT per IMWGa, n (%)
   ≥CR
15 (37.5)
2 (18.2)
13 (44.8)
   ≥VGPR
29 (72.5)
6 (54.5)
23 (79.3)
Abbreviations: CR, complete response; IMWG, International Myeloma Working Group; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.
aFor patients that underwent ASCT during the study, the best response until the day of the ASCT is presented. For patients without ASCT during the study, the overall best response is presented.
  • Of 19 MRD-evaluable patients, 15 (78.9%) achieved MRD-negativity (10-5; NDMM, n=13; RMM, n=2).4
  • The median PFS for all patients was 25.8 months (95% CI, 10.2-not reached [NR]).4
    • Median PFS was longer for patients with NDMM (NR; 95% CI, 7.2-NR) vs RMM (15.3 months; 95% CI, 1.0-NR), 1-2 plasmacytomas (34.5 months; 95% CI, 11.5-NR) vs ≥3 plasmacytomas (12.8 months; 95% CI, 2.2-NR), and EMD plasmacytoma (20.1 months; 95% CI, 6.3-NR) vs paraskeletal plasmacytoma only (34.5 months; 95% CI, 4.7-NR).
  • For all patients, the median OS was NR; for patients with NDMM, median OS was NR (95% CI, 29.3-NR) vs 25.8 months (95% CI, 2.4-NR) in patients with RMM.4
Safety
  • Thirty-nine patients (97.5%) experienced one or more TEAE.4
    • The most common any grade hematologic TEAEs were thrombocytopenia (37.5%), anemia (35.0%), and neutropenia (30.0%)
    • The most common any grade non-hematologic TEAEs were upper respiratory tract infection (42.5%), COVID-19 (37.5%), and hypogammaglobulinemia (37.5%).
  • Thirteen patients (32.5%) experienced one or more grade 3/4 TEAE, most commonly pneumonia (12.5%) and COVID-19 infection (7.5%).4
  • Serious AEs occurred in 18 patients (45.0%).4
  • Serious AEs leading to death occurred in 4 patients (10.0%) and included myocardial infarction, COVID-19, myocarditis infectious, and pneumonia cytomegaloviral (n=1 each).4
    • Pneumonia cytomegaloviral was the only grade 5 event related to study treatment.

Retrospective Analysis of 7 Clinical Trials in Patients with RRMM With and Without EMD

Kumar et al (2024)5 presented results from a retrospective, descriptive analysis involving secondary use of historical data from 7 clinical trials in patients with RRMM with and without EMD.

Study Design/Methods

  • The 7 historical clinical trials in this analysis included the Phase 1 trials: MMY1003 and PAVO and the Phase 3 trials: COLUMBA, POLLUX, APOLLO, CASTOR, and LEPUS.5
  • Patients were categorized based on EMD at baseline (0=no, ≥1=yes).5
  • Primary endpoint: ORR based on International Myeloma Working Group (IMWG) criteria.5
  • Time-to-event endpoints: progression and death.5

Results

Patient Characteristics

Ranges of Baseline Characteristics for All Treatment Cohortsa,5
Characteristic
With EMD
(n=121)
Without EMD
(n=2153)
Age, years
53-74
61-69
Female, %
25-65
39-56
Baseline hemoglobin, g/L
99-130
105-118
Baseline creatinine clearance, mL/min/1.73 m2
70-104
67-82
Prior ASCT,b %
0-78
20-75
Refractory status, %
   None
0-50
0-41
   Last LOTb
0-100
27-84
   PI only
0-50
3-71
   IMiD only
0-80
11-91
   PI and IMiDc
0-100
6-54
Median no. of prior lines of therapy
   Across 2 phase 1 studies
4-5
3-4
   Across 5 phase 3 studies
1-5
1-4
Race,d %
   White
33-100
66-89
   Asiane
0-56
1-18
   Black/African American
0-11
0-10
ECOG PS, %
   0
0-60
24-60
   ≥1
40-100
40-76
ISS stagef
   I/II
67-88
69-84
   III
12-33
16-31
Abbreviations: ASCT, autologous stem cell transplant; ECOG PS, Eastern Cooperative Oncology Group performance status; EMD, extramedullary disease; IMiD, immunomodulatory drug; ISS, International Staging System; LOT, line of therapy; PI, proteasome inhibitor.
aIncludes all studies unless otherwise noted.
bExcludes APOLLO, which did not report prior ASCT or refractory status to last LOT.
cExcludes LEPUS, which did not report if the patients were refractory to both a PI and an IMiD.
dExcludes MMY1003 and LEPUS, in which all patients were Asian.
ePAVO did not report an Asian population.
fExcludes MMY1003, which did not report ISS stage.
Efficacy

Summary of ORR, Disease Progression, and Deaths in Patients with EMD in the First Year of Treatment in 7 Historical Clinical Trialsa,5
MMY1003
PAVOa
COLUMBAa
POLLUXa
APOLLOa
CASTORa
LEPUS
DARZALEX
DARZALEX
DARZALEX
DARZALEX FASPRO
D-Rd
Rd
D-Pd
Pd
D-Vd
Vd
D-Vd
Vd
W/o
EMD
(n=48)
W/
EMD
(n=2)
W/o
EMD
(n=116)
W/
EMD
(n=4)
W/o
EMD
(n=241)
W/
EMD
(n=18)
W/o
EMD
(n=241)
W/
EMD
(n=17)
W/o
EMD
(n=277)
W/
EMD
(n=9)
W/o
EMD
(n=277)
W/
EMD
(n=6)
W/o
EMD
(n=136)
W/
EMD
(n=15)
W/o
EMD
(n=145)
W/
EMD
(n=8)
W/o
EMD
(n=242)
W/
EMD
(n=9)
W/o
EMD
(n=233)
W/ EMD
(n=14)
W/o
EMD
(n=126)
W/
EMD
(n=15)
W/o
EMD
(n=66)
W/
EMD
(n=4)
ORR, n (%)
23
(47.9)
0
(0)
51
(44)
0
(0)
103
(42.7)
0
(0)
114
(46.3)
1
(5.9)
257
(92.8)
4
(44.4)
209
(75.5)
2
(33.3)
101
(74.3)
4
(26.7)
69
(47.6)
3
(37.5)
200
(82.6)
3
(33.3)
145
(62.2)
3
(21.4)
109
(86.5)
7
(46.7)
40
(60.6)
2
(50.0)
Patients who progressed or died in the first year of treatment, n (%)
28
(58.3)
2
(100)
71
(61.2)
4
(100)
160
(66.4)
16
(88.9)
162
(65.9)
14
(82.4)
41
(14.8)
5
(55.6)
105
(37.9)
4
(66.7)
62
(45.6)
10
(66.7)
84
(57.9)
8
(100)
95
(39.3)
3
(33.3)
162
(69.5)
11
(78.6)
51
(40.5)
7
(46.7)
44
(66.7)
2
(50.0)
Patients who died in the first year of treatment, n (%)
14
(29.2)
0
(0)
8
(6.9)
2
(50.0)
60
(24.9)
10
(55.6)
59
(24.0)
7
(41.2)
21
(7.6)
1
(11.1)
33
(11.9)
4
(66.7)
29
(21.3)
4
(26.7)
30
(20.7)
4
(50.0)
32
(13.2)
3
(33.3)
41
(17.6)
5
(35.7)
17
(13.5)
4
(26.7)
16
(24.2)
1
(25.0)
Abbreviations: D-Pd, DARZALEX + pomalidomide + dexamethasone; D-Rd, DARZALEX + lenalidomide + dexamethasone; D-Vd, DARZALEX + bortezomib + dexamethasone; EMD, extramedullary disease; ORR, overall response rate; Pd, pomalidomide + dexamethasone; Rd, lenalidomide + dexamethasone; Vd, bortezomib + dexamethasone; W/, with; W/o, without.
aEMD defined in these studies as soft tissue plasmacytomas only, excluding paramedullary lesions or soft tissue lesions contiguous with medullary lesions.

Retrospective, Multicenter Study in Patients with RRMM and EMD

Jelinek et al (2022)6 conducted a retrospective study to evaluate the efficacy of DARZALEX monotherapy and D-Rd in patients with RRMM and EMD.

Study Design/Methods

  • A retrospective, multicenter study in patients with RRMM who were administered DARZALEX monotherapy (N=41) or D-Rd (N=186) treatment regimen.6
  • The presence of EMD was evaluated according to institutional guidelines by positron emission tomography (PET)/computed tomography (CT), magnetic resonance imaging (MRI), or CT; both bone-related and soft tissue lesions were considered as EMD.6

Results

Patient Characteristics

Key Baseline Demographics and Disease Characteristics of Patients with EMD20
Demographics
DARZALEX Monotherapy
D-Rd
Total EMD patients, n
14
41
Median age, years (range)
57 (40-72)
61 (44-85)
Extramedullary type
n=10
n=41
   EM-S (%)
20
24
   EM-B (%)
80
76
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; EM-B extramedullary mass bone related; EM-S, extramedullary mass soft tissue; EMD, extramedullary disease.
Efficacy

Demographics and Characteristic of Patients Treated with DARZALEX Monotherapy20
Characteristic
EMD
(n=14)
No EMD
(n=27)
Total
(N=41)
Median age, years (range)
57 (40-72)
68 (37-80)
63 (37-80)
Gender, n (%)
   Women
9 (64.3)
14 (51.9)
23 (56.1)
   Men
5 (35.7)
13 (48.1)
18 (43.9)
Myeloma-protein type, n (%)
n=10
n=21
n=31
   IgG
6 (60.0)
7 (33.3)
13 (41.9
   IgA
2 (20.0)
9 (42.9)
11 (35.5)
   LC only
2 (20.0)
3 (14.3)
5 (16.1)
   Other
-
2 (9.6)
1 (6.4)
Number of previous treatment lines
n=14
n=27
n=41
   Median (range)
5 (3-6)
5 (3-8)
5 (3-8)
Maximal response, n (%)
n=14
n=24
n=38
   VGPR
2 (14.3)
2 (8.3)
4 (10.5)
   PR
1 (7.1)
10 (41.7)
11 (28.9)
   MR
1 (7.1)
4 (16.7)
5 (13.2)
   SD
5 (35.7)
5 (20.8)
10 (26.3)
   PD
5 (35.7)
3 (12.5)
8 (21.1)
ORR (≥PR)
n=14
n=24
n=38
   n (%; 95% CI)
3 (21.4; 4.7-50.8)
12 (50.0; 29.1-70.9)
15 (39.5; 24.0-56.6)
PFS, months
n=14
n=27
n=41
   Median (95% CI)
1.4 (0.2-2.5)
6.2 (3.0-9.4)
4.6 (3.1-6.1)
OS, months
n=14
n=27
n=41
   Median (95% CI)
4.6 (0.0-12.0)
15.4 (8.2-22.7)
12.7 (10.1-15.2)
Abbreviations: CI, confidence interval; EMD, extramedullary disease; Ig, immunoglobulin; LC, light chain; MR, minimal response; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease; VGPR, very good partial response.
  • Of the 186 patients with RRMM who were administered D-Rd, 22% (n=41) had EMD. See Table: Demographics and Characteristic of Patients Treated with D-Rd.20
    • In patients with EMD (n=41) vs without EMD (n=145), the ORR was 57.7% vs 84.5% (P=0.0048), and median PFS was 7.8 months vs 27.3 months (P=0.002), respectively.
  • In patients with soft tissue EMD (n=10) vs bone-related EMD (n=31), PFS was 4.8 months vs 8.4 months (P=0.549), respectively.6

Demographics and Characteristic of Patients Treated with D-Rd20
Characteristic
EMD
(n=41)
No EMD
(n=145)
Total
(N=186)
Median age, years (range)
61 (44-85)
66 (37-84)
65 (37-85)
Gender, n (%)
   Women
18 (43.9)
65 (44.8)
83 (44.6)
   Men
23 (56.1)
80 (55.2)
103 (55.4)
Myeloma-protein type, n (%)
   IgG
22 (53.7)
85 (58.6)
107 (57.5)
   IgA
9 (22.0)
34 (23.4)
43 (23.1)
   LC only
6 (14.6)
23 (15.9)
29 (15.6)
   Other
4 (9.7)
3 (2.1)
7 (3.7)
Number of previous treatment lines
   Median (range)
1 (1-7)
1 (1-9)
1 (1-9)
Maximal response, n (%)
n=26
n=89
n=115
   sCR
2 (7.7)
5 (5.6)
7 (6.1)
   CR
-
9 (10.1)
9 (7.8)
   VGPR
9 (34.6)
36 (40.4)
45 (39.1)
   PR
4 (15.4)
26 (29.2)
30 (26.1)
   MR
2 (7.7)
8 (9.0)
10 (8.7)
   SD
6 (23.1)
4 (4.5)
10 (8.7)
   PD
3 (11.5)
1 (1.1)
4 (3.5)
ORR (≥PR)
n=26
n=89
n=115
   n (%; 95% CI)
15 (57.7; 36.9-76.6)
76 (85.4%; 76.3-92.0)
91 (79.1; 70.6-86.1)
PFS, months
n=41
n=145
n=186
   Median (95% CI)
7.8 (3.0-12.6)
27.3 (10.8-43.8)
26.8 (12.2-41.3)
Abbreviations: CI, confidence interval; D-Rd, DARZALEX + lenalidomide + dexamethasone; EMD, extramedullary disease; Ig, immunoglobulin; LC, light chain; MR, minimal response; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.

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 16 June 2026.

 

References

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