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(daratumumab and hyaluronidase-fihj)

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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

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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

DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf.
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.

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

Overall, 107 (14.5%) patients received concomitant vaccines during the study (see Table: Summary of Concomitant Vaccines in the ITT Population in MAIA).²

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

Overall, 22 (3.1%) patients received concomitant vaccines during the study (see Table: Summary of Concomitant Vaccines in the ITT Population in ALCYONE).⁴

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)

Overall, 53 (4.9%) patients received concomitant vaccines during Part 1 of the study; see Table: Summary of Concomitant Vaccines in the ITT Population in CASSIOPEIA (Part 1).⁷

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)

Overall, 229 (25.9%) patients in the safety analysis set (N=884) received concomitant vaccines during Part 2 (maintenance phase) of the study; see Table: Summary of Concomitant Vaccines in the Safety Analysis Set in CASSIOPEIA (Part 2).⁸

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

Overall, 17 (3.4%) patients received concomitant vaccines during the study (see Table: Summary of Concomitant Vaccines in the ITT Population in CASTOR).¹⁰

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

Overall, 49 (8.6%) patients received concomitant vaccines during the study (see Table: Summary of Concomitant Vaccines in the ITT Population in POLLUX).¹²

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

Overall, 9 (7.3%) patients received concomitant vaccines in the study (see Table: Summary of Concomitant Vaccines in the All-Treated Analysis Population in SIRIUS).¹⁴

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

In the safety analysis set, 4 (2.68%) patients treated with DARZALEX-Pd, 4 (2.82%) patients treated with DARZALEX FASPRO-Pd, and 4 (2.67%) patients treated with Pd received concomitant vaccines during the study (see Table: Summary of Concomitant Vaccines in the Safety Analysis Set in APOLLO).¹⁶

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

Overall, 12 (18.2%) patients in the D-Kd arm, 2 (3%) patients in D-VRd arm, 9 (13.4%) patients in D-VMP arm, and 4 (6.2%) patients in D-Rd arm, received concomitant vaccines (see Table: Summary of Concomitant Vaccines in the All-Treated Analysis Population in PLEIADES).¹⁸^,¹⁹
- Vaccination with live attenuated vaccines were prohibited in the study.²⁰

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

Overall, 21 (4.1%) patients received concomitant vaccines in the study (see Table: Summary of Concomitant Vaccines in the Safety Analysis Population in COLUMBA).²²

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

Overall, 26 (6.8%) patients received concomitant vaccines in the study (see Table: Summary of Concomitant Vaccines in the Safety Analysis Population in ANDROMEDA).²⁴

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

Overall, 548 (78.5%) patients received concomitant vaccines in the study (see Table: Summary of Concomitant Vaccines in the Safety Analysis Population of PERSEUS).²⁶

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

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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	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.
14	Data on File. Daratumumab. SIRIUS Clinical Study Report. Janssen Research & Development, LLC. EDMS-ERI-92399922, 1.0; 2015.
15	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.
16	Data on File. Daratumumab and hyaluronidase. Clinical Study Report APOLLO. Janssen Research & Development, LLC. EDMS-ERI-196777974; 2020.
17	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.
18	Data on File. Daratumumab. Clinical Study Report PLEIADES. Primary Analysis for D-Kd Cohort. Janssen Research & Development, LLC. EDMS RIM-138335; 2021.
19	Data on File. Daratumumab. Clinical Study Report PLEIADES. Primary Analysis for D-VMP, D-Rd, and D-VRd Cohorts. Janssen Research & Development, LLC. EDMS-ERI-174439798; 2019.
20	Data on File. Daratumumab and Hyaluronidase. PLEAIDES Clinical Protocol. Janssen Research & Development, LLC. EDMS-ERI-147474836; 2020.
21	MV Mateos, H Nahi, W Legiec, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020;7:e370-e380.
22	Data on File. Daratumumab and hyaluronidase. Synoptic Clinical Study Report COLUMBA: 6-Month Update. Janssen Research & Development, LLC. EDMS-ERI-186384790; 2019.
23	Kastritis E, Palladini G, Minnema M, et al. Daratumumab-based treatment for immunoglobulin light-chain amyloidosis. N Engl J Med. 2021;385(1):46-58.
24	Data on File. Daratumumab and hyaluronidase. ANDROMEDA Clinical Study Report. Janssen Research & Development, LLC. EDMS-ERI-196853318, 1.0; 2020.
25	Sonneveld P, Dimopoulos MA, Boccadoro M, et al. Daratumumab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2024;390(4)(4):301-313.
26	Data on File. Daratumumab and hyaluronidase. PERSEUS Clinical Study Report. Janssen Research & Development, LLC. EDMS-RIM-973762; 2024.
27	Bulla A, Romano A, Morella M, et al. Vaccination against seasonal influenza and pneumonia improves clinical outcome in multiple myeloma patients receiving continuous treatment with lenalidomide: A real-life survey. HemaSphere. 2021;5:473-474.
28	Frerichs KA, Bosman PWC, Velzen JF van, et al. Effect of daratumumab on normal plasma cells, polyclonal immunoglobulin levels, and vaccination responses in extensively pre-treated multiple myeloma patients. Haematologica. 2020;105(6):e302-e306.
29	Gressens SB, Enouf V, Créon A, et al. Serological responses against seasonal influenza viruses in patients with multiple myeloma treated or untreated with daratumumab after two doses of tetravalent vaccine. Int J Infect Dis. 2024;146:107108.

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