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DARZALEX® (daratumumab)

Medical Information

Concomitant Use of DARZALEX + DARZALEX FASPRO with Vaccines

Last Updated: 05/16/2025

SUMMARY

  • Data regarding the number of patients who received concomitant vaccines with DARZALEX are presented from the following studies:
    • MAIA1,2: 60 (16.3%) patients with newly diagnosed multiple myeloma (NDMM)
    • ALCYONE3,4: 11 (3.1%) patients with NDMM.
    • CASSIOPEIA5-8: 24 (4.4%) patients (Part 1) and 104 (23.6%) patients (Part 2) with NDMM.
    • CASTOR9,10: 11 (4.4%) patients with relapsed or refractory multiple myeloma (RRMM).
    • POLLUX11,12: 26 (9.1%) patients with RRMM
    • SIRIUS13,14: 8 (7.5%) patients with RRMM who had received ≥3 prior lines of therapy or were double refractory (i.e., refractory to both a proteasome inhibitor [PI] and an immunomodulatory drug [IMiD]).
  • Data regarding the number of patients who received concomitant vaccines with DARZALEX FASPRO are presented from the following studies:
    • APOLLO15,16: in patients with RRMM, 4 (2.68%) patients who received DARZALEX + pomalidomide + dexamethasone (DARZALEX-Pd), and 4 (2.82%) patients who received DARZALEX FASPRO-Pd.
    • PLEIADES17-20: 12 (18.2%) patients with RRMM in the DARZALEX FASPRO + carfilzomib + dexamethasone (D-Kd) arm, 2 (3.0%) NDMM patients in the DARZALEX FASPRO + bortezomib + lenalidomide + dexamethasone (D-VRd) arm, 9 (13.4%) NDMM patients in the DARZALEX FASPRO + bortezomib + melphalan + prednisone (D-VMP) arm, and 4 (6.2%) RRMM patients in the DARZALEX FASPRO + lenalidomide + dexamethasone (D-Rd) arm. Vaccination with live attenuated vaccines were prohibited in the study.
    • COLUMBA21,22: 10 (3.9%) patients in the DARZALEX arm vs 11 (4.2%) patients in the DARZALEX FASPRO arm with multiple myeloma (MM) who had received ≥3 prior lines of therapy or were double refractory (i.e., refractory to both a PI and an IMiD)
    • ANDROMEDA23,24: 19 (9.8%) in newly diagnosed patients with systemic light chain (AL) amyloidosis.
    • PERSEUS25,26: 297 (84.6%) patients with NDMM eligible for autologous stem cell transplant (ASCT).
  • Other relevant literature describing the concomitant use of DARZALEX/DARZALEX FASPRO with vaccines are referenced in addition to the data summarized below.27-29

PRODUCT LABELING

CLINICAL DATA

DARZALEX in Combination with Lenalidomide and Dexamethasone in NDMM

MAIA (MMY3008; NCT02252172) is an international, phase 3, randomized, open-label, active-controlled, multicenter study evaluating the safety and efficacy of DARZALEX in combination with lenalidomide + dexamethasone (D-Rd) compared to lenalidomide + dexamethasone (Rd) in patients with NDMM not eligible for high-dose chemotherapy (HDT) and ASCT; N=737.1

Results


Summary of Concomitant Vaccines in the ITT Population in MAIA2
Vaccine, n (%)
Rd (n=369)
D-Rd (n=368)
Total (N=737)
Vaccines
47 (12.7)
60 (16.3)
107 (14.5)
Viral vaccines
31 (8.4)
44 (12.0)
75 (10.2)
Influenza vaccine
31 (8.4)
42 (11.4)
73 (9.9)
Hepatitis A vaccine
0
1 (0.3)
1 (0.1)
Hepatitis B vaccine
0
1 (0.3)
1 (0.1)
Varicella zoster vaccine
0
1 (0.3)
1 (0.1)
Bacterial vaccines
23 (6.2)
21 (5.7)
44 (6.0)
Pneumococcal vaccine
20 (5.4)
18 (4.9)
38 (5.2)
Tetanus vaccine
3 (0.8)
2 (0.5)
5 (0.7)
Haemophilus influenzae type b vaccine
1 (0.3)
2 (0.5)
3 (0.4)
Diphtheria vaccine toxoid w/pertussis/09399801/
1 (0.3)
0
1 (0.1)
Diphtheria vaccine toxoid w/tetanus vaccine t
0
1 (0.3)
1 (0.1)
Pneumococcal vaccines
0
1 (0.3)
1 (0.1)
Typhoid vaccines
1 (0.3)
0
1 (0.1)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; ITT, intent-to-treat; Rd, lenalidomide + dexamethasone; t, toxoid; w, whole cell.

DARZALEX in Combination with Bortezomib, Melphalan, and Prednisone in NDMM

ALCYONE (MMY3007; NCT02195479) is a phase 3, randomized, open-label, parallel-group, active-controlled, multicenter study comparing D-VMP vs bortezomib, melphalan, and prednisone (VMP) in patients with previously untreated MM who are ineligible for HDT with ASCT (N=706).3

Results


Summary of Concomitant Vaccines in the ITT Population in ALCYONE4
Vaccine, n (%)
VMP
(n=356)
D-VMP
(n=350)
Total
(N=706)
Vaccines
11 (3.1)
11 (3.1)
22 (3.1)
Bacterial vaccines
8 (2.2)
8 (2.3)
16 (2.3)
Pneumococcal vaccine
7 (2.0)
8 (2.3)
15 (2.1)
Haemophilus influenza type b vaccine
2 (0.6)
3 (0.9)
5 (0.7)
Meningococcal vaccine
3 (0.8)
1 (0.3)
4 (0.6)
Tetanus vaccine
1 (0.3)
0
1 (0.1)
Vaccin ipad d.t.c.
0
1 (0.3)
1 (0.1)
Viral vaccines
5 (1.4)
6 (1.7)
11 (1.6)
Influenza vaccine
5 (1.4)
5 (1.4)
10 (1.4)
Hepatitis B vaccine
0
1 (0.3)
1 (0.1)
Abbreviations: d.t.c., diphtheria, tetanus, and pertussis; D-VMP, DARZALEX + bortezomib + melphalan + prednisone; ITT, intent-to-treat; VMP, bortezomib + melphalan + prednisone.

DARZALEX in Combination with Bortezomib, Thalidomide, and Dexamethasone in NDMM

CASSIOPEIA (MMY3006; NCT02541383) is an open-label, 2-arm, multicenter, randomized, phase 3 study evaluating the safety and efficacy of DARZALEX in combination with bortezomib, thalidomide, and dexamethasone (D-VTd) in patients with previously untreated MM who are eligible for HDT and ASCT (N=1,085).5,6

Results (Part 1)


Summary of Concomitant Vaccines in the ITT Population in CASSIOPEIA (Part 1)7
Vaccine, n (%)
VTd (n=542)
D-VTd (n=543)
Total (N=1085)
Vaccines
29 (5.4)
24 (4.4)
53 (4.9)
Viral vaccines
8 (1.5)
7 (1.3)
15 (1.4)
Influenza vaccine
8 (1.5)
7 (1.3)
15 (1.4)
Bacterial vaccines
23 (4.2)
18 (3.3)
41 (3.8)
Pneumococcal vaccine
23 (4.2)
18 (3.3)
41 (3.8)
Hib vaccine
1 (0.2)
2 (0.4)
3 (0.3)
    Bacterial and viral vaccine, combined
1 (0.2)
1 (0.2)
2 (0.2)
Diphtheria vaccine toxoid w/hepatit/09413401/
0
1 (0.2)
1 (0.1)
Diphtheria vaccine toxoid w/polio/09411801/
1 (0.2)
0
1 (0.1)
Abbreviations: D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; ITT, intent-to-treat; VTd, bortezomib + thalidomide + dexamethasone.

Results (Part 2)


Summary of Concomitant Vaccines in the Safety Analysis Set in CASSIOPEIA (Part 2)8
Vaccine, n (%)
Observation (n=444)
DARZALEX (n=440)
Total (N=884)
Vaccines
125 (28.2)
104 (23.6)
229 (25.9)
Viral vaccines
73 (16.4)
66 (15.0)
139 (15.7)
Influenza vaccine
69 (15.5)
66 (15.0)
135 (15.3)
Measles vaccine live (schwartz) W/M/09401201/
2 (0.5)
1 (0.2)
3 (0.3)
Hepatitis B vaccine
2 (0.5)
0
2 (0.2)
Varicella zoster vaccine
0
1 (0.2)
1 (0.1)
Bacterial vaccines
89 (20.0)
70 (15.9)
159 (18.0)
Pneumococcal vaccine
87 (19.6)
68 (15.5)
155 (17.5)
Meningococcal vaccine
10 (2.3)
6 (1.4)
16 (1.8)
Haemophilus influenzae b vaccines
7 (1.6)
8 (1.8)
15 (1.7)
Hib vaccine
8 (1.8)
6 (1.4)
14 (1.6)
Diphtheria vaccine toxoid w/pertuss/09399901/
7 (1.6)
5 (1.1)
12 (1.4)
Tetanus vaccine
0
2 (0.5)
2 (0.2)
    Bacterial and viral vaccine, combined
32 (7.2)
17 (3.9)
49 (5.5)
Diphtheria vaccine toxoid w/hepatit/09413401/
10 (2.3)
6 (1.4)
16 (1.8)
Diphtheria vaccine toxoid w/polio/09411801/
7 (1.6)
1 (0.2)
8 (0.9)
Bacterial and viral vaccines, combined
3 (0.7)
3 (0.7)
6 (0.7)
Diphtheria vaccine toxoid w/hib vac/09405801/
3 (0.7)
3 (0.7)
6 (0.7)
Diphtheria vaccine toxoid w/hib vac/09405101/
4 (0.9)
1 (0.2)
5 (0.6)
Diphtheria vaccine toxoid w/pertuss/09400401/
3 (0.7)
1 (0.2)
4 (0.5)
Diphtheria vaccine toxoid w/pertuss/09400501/
2 (0.5)
0
2 (0.2)
Diphtheria vaccine toxoid w/pertuss/09401701/
1 (0.2)
1 (0.2)
2 (0.2)
Diphtheria vaccine toxoid w/polio vaccine/tet
0
1 (0.2)
1 (0.1)

DARZALEX in Combination with Bortezomib and Dexamethasone in RRMM

CASTOR (MMY3004; NCT02136134) is a multicenter, randomized, open-label, active controlled, phase 3 study that evaluated the safety and efficacy of DARZALEX in combination with bortezomib and dexamethasone (D-Vd) compared to bortezomib and dexamethasone (Vd) alone in patients with RRMM (N=498).9

Results


Summary of Concomitant Vaccines in the ITT Population in CASTOR10
Vaccine, n (%)
Vd (n=247)
D-Vd (n=251)
Total (N=498)
Vaccines
6 (2.4)
11 (4.4)
17 (3.4)
Viral vaccines
5 (2.0)
11 (4.4)
16 (3.2)
Influenza vaccine
5 (2.0)
9 (3.6)
14 (2.8)
Hepatitis A vaccine
0
1 (0.4)
1 (0.2)
Hepatitis B vaccine
0
1 (0.4)
1 (0.2)
Measles mumps & rubella live attenuated
0
1 (0.4)
1 (0.2)
Bacterial vaccines
1 (0.4)
1 (0.4)
2 (0.4)
Tetanus vaccine
1 (0.4)
0
1 (0.2)
Typhoid vaccine
0
1 (0.4)
1 (0.2)
    Bacterial and viral vaccines, combined
0
1 (0.4)
1 (0.2)
Quadracel
0
1 (0.4)
1 (0.2)
Abbreviations: D-Vd, DARZALEX + bortezomib + dexamethasone; ITT, intent-to-treat; Vd, bortezomib + dexamethasone.

DARZALEX in Combination with Lenalidomide and Dexamethasone in RRMM

POLLUX (MMY3003; NCT02076009) is a randomized, open-label, active-controlled, multicenter, phase 3 study that evaluated the efficacy and safety of D-Rd vs Rd in patients with RRMM (N=569).11

Results


Summary of Concomitant Vaccines in the ITT Population in POLLUX12
Vaccine, n (%)
Rd (n=283)
D-Rd (n=286)
Total (N=569)
Vaccines
23 (8.1)
26 (9.1)
49 (8.6)
Viral vaccines
21 (7.4)
25 (8.7)
46 (8.1)
Influenza vaccine
19 (6.7)
24 (8.4)
43 (7.6)
Hepatitis A vaccine
1 (0.4)
0
1 (0.2)
Hepatitis B vaccine
0
1 (0.3)
1 (0.2)
Measles mumps & rubella live attenuated
1 (0.4)
0
1 (0.2)
Yellow fever vaccine
1 (0.4)
0
1 (0.2)
Bacterial vaccines
6 (2.1)
1 (0.3)
7 (1.2)
Pneumococcal vaccine
5 (1.8)
1 (0.3)
6 (1.1)
Ditemer
1 (0.4)
0
1 (0.2)
Haemophilus influenza type b vaccine
1 (0.4)
0
1 (0.2)
Vaccin ipad d.t.c.
1 (0.4)
0
1 (0.2)
Abbreviations: D-Rd, DARZALEX + lenalidomide + dexamethasone; d.t.c., diphtheria, tetanus, and pertussis; ITT, intent-to-treat; Rd, lenalidomide + dexamethasone.

DARZALEX Monotherapy in RRMM

SIRIUS (MMY2002; NCT01985126) is a phase 2 study evaluating DARZALEX monotherapy in patients with MM who have received ≥3 prior lines of therapy including a PI and an IMiD or have disease refractory to both (N=124).13

Results


Summary of Concomitant Vaccines in the All-Treated Analysis Population in SIRIUS14
Vaccine, n (%)
DARZALEX
16 mg/kg (n=106)
DARZALEX
8 mg/kg (n=18)
Total (N=124)
Vaccines
8 (7.5)
1 (5.6)
9 (7.3)
Influenza vaccine
7 (6.6)
1 (5.6)
8 (6.5)
Pneumococcal vaccine
1 (0.9)
0
1 (0.8)

DARZALEX FASPRO in Combination with Pomalidomide and Dexamethasone in RRMM

APOLLO (MMY3013; NCT03180736) is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of daratumumab in combination with pomalidomide and dexamethasone (D-Pd) vs pomalidomide and dexamethasone (Pd) in patients with RRMM who received ≥1 prior treatment with both lenalidomide and a PI.15

Results


Summary of Concomitant Vaccines in the Safety Analysis Set in APOLLO16
Vaccine, n (%)
Pd (n=150)
DARZALEX-Pd (n=149)
DARZALEX FASPRO-Pd (N=142)
Vaccines
4 (2.67)
4 (2.68)
4 (2.82)
Viral vaccines
4 (2.67)
3 (2.01)
3 (2.11)
Influenza vaccine
2 (1.33)
3 (2.01)
3 (2.11)
Influenza vaccine inactivated split 3V
2 (1.33)
0
0
Bacterial vaccines
0
3 (2.01)
3 (2.11)
Hib vaccine
0
1 (0.67)
1 (0.70)
Hib vaccine conjugate (tetanus toxoid)
0
1 (0.67)
1 (0.70)
Pneumococcal vaccine 13V
0
1 (0.67)
1 (0.70)
Pneumococcal vaccine polysaccharide 23V
0
1 (0.67)
1 (0.70)
Abbreviations: D-Pd, daratumumab + pomalidomide + dexamethasone; Pd, pomalidomide + dexamethasone; SC, subcutaneous; V, valent.

DARZALEX FASPRO in Combination with Four Standard-of-Care Treatment Regimens in Patients with MM

PLEIADES (MMY2040; NCT03412565) is a phase 2, multicenter, open-label study evaluating the clinical benefit of DARZALEX FASPRO administered in combination with 4 standard of care treatment regimens in patients with MM. Specifically with:17

  • D-VRd for patients with transplant-eligible NDMM (n=67).
  • D-VMP for patients with transplant-ineligible NDMM (n=67).
  • D-Rd for patients with RRMM with ≥1 prior line of therapy (n=65).
  • D-Kd in patients with RRMM with 1 prior line of therapy (n=66).

Results


Summary of Concomitant Vaccines in the All-Treated Analysis Population in PLEIADES18,19
Vaccine, n (%)
D-Kd (N=66)
D-VRd (N=67)
D-VMP (N=67)
D-Rd (N=65)
Vaccines
12 (18.2)
2 (3)
9 (13.4)
4 (6.2)
Viral vaccines
12 (18.2)
2 (3)
7 (10.4)
3 (4.6)
Influenza vaccine
11 (16.7)
1 (1.5)
7 (10.4)
3 (4.6)
Hepatitis A vaccine
1 (1.5)
-
-
-
Hepatitis A vaccine inactivated; hepatitis b vaccine rhHBag (yeast)
1 (1.5)
-
-
-
Hepatitis B vaccine
1 (1.5)
1 (1.5)
1 (1.5)
0
Bacterial vaccines
3 (4.5)
0
2 (3)
2 (3.1)
Pneumococcal vaccine
2 (3.0)
0
2 (3)
1 (1.5)
Diphtheria vaccine; tetanus vaccine
1 (1.5)
-
-
-
Meningococcal vaccine
1 (1.5)
-
-
-
Tetanus vaccine
-
0
0
1 (1.5)
Bacterial and viral vaccines, combined
1 (1.5)
-
-
-
Diphtheria vaccine toxoid; hepatitis b vaccine rhbsag; haemophilus influenzae type b vaccine conjugate (tet tox);pertussis vaccine acellular 2component; polio vaccine inactivated 3v (vero); tetanus vaccine toxoid
1 (1.5)
-
-
-
Abbreviations: D-Kd, DARZALEX FASPRO + carfilzomib + dexamethasone; D-Rd, DARZALEX FASPRO + lenalidomide + dexamethasone; D-VMP, DARZALEX FASPRO + bortezomib + melphalan + prednisone; D-VRd, DARZALEX FASPRO + bortezomib + lenalidomide + dexamethasone.

Non-Inferiority Study of DARZALEX vs DARZALEX FASPRO in RRMM

COLUMBA (MMY3012; NCT03277105) is a phase 3, randomized, open-label, multicenter non-inferiority study evaluating the efficacy, pharmacokinetics, and infusion-related reactions of DARZALEX vs DARZALEX FASPRO in patients with RRMM.21

Results


Summary of Concomitant Vaccines in the Safety Analysis Population in COLUMBA22
Vaccine, n (%)
DARZALEX (n=258)
DARZALEX FASPRO
(n=260)
Total (N=518)
Vaccines
10 (3.9)
11 (4.2)
21 (4.1)
Influenza vaccine
9 (3.5)
10 (3.8)
19 (3.7)
Pneumococcal vaccine
2 (0.8)
1 (0.4)
3 (0.6)

DARZALEX FASPRO in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone for AL Amyloidosis

ANDROMEDA (AMY3001; NCT03201965) is a phase 3, randomized, open-label, active-controlled, multicenter study evaluating the efficacy and safety of DARZALEX FASPRO in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared with bortezomib, cyclophosphamide, and dexamethasone (VCd) in newly diagnosed patients with systemic AL amyloidosis.23

Results


Summary of Concomitant Vaccines in the Safety Analysis Population in ANDROMEDA24
Vaccine, n (%)
VCd
(n=188)
D-VCd
(n=193)
Total (N=381)
Vaccines
7 (3.7)
19 (9.8)
26 (6.8)
Viral vaccines
6 (3.2)
16 (8.3)
22 (5.8)
Influenza vaccine
6 (3.2)
14 (7.3)
20 (5.2)
Twinrix
0
1 (0.5)
1 (0.3)
Varicella zoster vaccine
0
1 (0.5)
1 (0.3)
Varicella zoster vaccines
0
1 (0.5)
1 (0.3)
Bacterial vaccines
3 (1.6)
4 (2.1)
7 (1.8)
Pneumococcal vaccine
3 (1.6)
4 (2.1)
7 (1.8)
Bacterial and viral vaccines, combined
0
1 (0.5)
1 (0.3)
Hepatyrix
0
1 (0.5)
1 (0.3)
Abbreviations: D-VCd, DARZALEX FASPRO + bortezomib + cyclophosphamide + dexamethasone; VCd, bortezomib + cyclophosphamide + dexamethasone.

DARZALEX FASPRO in Combination with Bortezomib, Lenalidomide, and Dexamethasone in Patients With NDMM Eligible for ASCT

PERSEUS (MMY3014; NCT03710603) is an ongoing, open-label, multicenter, phase 3 study evaluating the efficacy and safety of D-VRd vs bortezomib, lenalidomide, and dexamethasone (VRd) induction and consolidation followed by maintenance with DARZALEX FASPRO and lenalidomide (D-R) in the D-VRd group or lenalidomide (R) in the VRd group in patients with NDMM eligible for ASCT.25

Results


Summary of the Concomitant Vaccines in the Safety Analysis Population of PERSEUS26 
Vaccine, n (%)
VRd
(n=347)
D-VRd
(n=351)
Total (N=698)
Overall
251 (72.3)
297 (84.6)
548 (78.5)
Viral vaccines
248 (71.5)
297 (84.6)
545 (78.1)
Bacterial vaccines
64 (18.4)
72 (20.5)
136 (19.5)
Bacterial and viral vaccines, combined
28 (8.1)
35 (10)
63 (9)
Abbreviations: D-VRd, DARZALEX FASPRO + bortezomib + lenalidomide + dexamethasone; VRd, bortezomib + lenalidomide + dexamethasone.

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 12 May 2025.

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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2 Data on File. Daratumumab. Clinical Study Report MAIA. Janssen Research & Development, LLC. EDMS-ERI-163297574; 2019.  
3 Mateos M, Dimopoulos M, Cavo M, et al. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. N Engl J Med. 2018;378:518-528.  
4 Data on File. Daratumumab. ALCYONE Clinical Study Report. Janssen Research & Development, LLC. EDMS-ERI-142718838, 1.0; 2017.  
5 Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019;394:29-38.  
6 Moreau P, Hulin C, Perrot A, et al. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(10):1378-1390.  
7 Daratumumab. Clinical Study Report CASSIOPEIA Part 1. Janssen Research & Development, LLC. EDMS-ERI-172588360. 2019.  
8 Daratumumab. Clinical Study Report CASSIOPEIA Part 2. Janssen Research & Development, LLC. EDMS-RIM-124149. 2021.  
9 Palumbo A, Chanan-Khan AAA, Weisel K, et al. Phase III randomized controlled study of daratumumab, bortezomib, and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study. J Clin Oncol. 2016;34(18_suppl):LBA4-LBA4.  
10 Data on File. Daratumumab. Clinical Study Report CASTOR. Janssen Research & Development, LLC.  EDMS-ERI-109466500; 2016.  
11 Dimopoulos M, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331.  
12 Data on File. Daratumumab. POLLUX Clinical Study Report. Janssen Research & Development, LLC.  EDMS-ERI-109466499, 1.0; 2016.  
13 Lonial S, Weiss BM, Usmani SZ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016;387(10027):1551-1560.  
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