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DARZALEX® (daratumumab)
Medical Information

DARZALEX + DARZALEX FASPRO - Use in Newly Diagnosed Multiple Myeloma in Patients Eligible for Autologous Stem Cell Transplant

Last Updated: 06/10/2026

SUMMARY

  • Johnson & Johnson does not recommend the use of DARZALEX/DARZALEX FASPRO in a manner that is inconsistent with the approved labeling.
  • PERSEUS is a phase 3 study evaluating the efficacy and safety of DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) vs bortezomib, lenalidomide, and dexamethasone alone (VRd) induction and consolidation followed by maintenance with DARZALEX FASPRO and lenalidomide (D-R) in D-VRd group or lenalidomide alone (R) in VRd group in patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplant (ASCT).1
    • Sonneveld et al (2023)1 reported efficacy and safety results from the PERSEUS study evaluating D-VRd vs VRd in patients with NDMM eligible for ASCT. At a median follow-up of 47.5 months, 14.1% of patients in the D-VRd group vs 29.1% of patients in the VRd group experienced disease progression or death (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.30-0.59; P<0.0001). The most common grade 3/4 adverse events (AEs) in the D-VRd vs VRd group were neutropenia (62.1% vs 51.0%), thrombocytopenia (29.1% vs 17.3%), diarrhea (10.5% vs 7.8%), pneumonia (10.5% vs 6.1%), and febrile neutropenia (9.4% vs 10.1%).
  • CASSIOPEIA is a phase 3 study evaluating the safety and efficacy of DARZALEX + bortezomib, thalidomide, and dexamethasone (D-VTd) in transplant eligible patients with previously untreated multiple myeloma (MM).2,3
    • Moreau et al (2024)4 reported long-term outcomes of the CASSIOPEIA study after a median follow-up of 80.1 months from the first randomization and at a median follow-up of 70.6 months from the second randomization. The median progression-free survival (PFS) from first randomization was 83.7 months in the D-VTd group vs 52.8 months in the VTd group (HR, 0.61; 95% CI, 0.52-0.72; P<0.0001). A total of 83 vs 139 deaths occurred in D-VTd vs bortezomib, thalidomide, and dexamethasone alone (VTd) group, respectively.
  • GRIFFIN is a phase 2 study evaluating the safety and efficacy of DARZALEX when administered in combination with VRd (D-VRd) for patients with NDMM who are eligible for high-dose therapy (HDT) and ASCT.5-7
    • Part 1: Voorhees et al (2021)8 reported the final analysis of the safety run-in cohort of the GRIFFIN study with a median follow-up of 40.8 months. By the end of D-VRd consolidation, 56.3% patients achieved stringent complete response (sCR), and 50.0% were minimal residual disease (MRD)-negative (10-5). After maintenance, 93.8% of patients achieved sCR, and 81.3% of patients were MRD-negative (10-5). Grade 3/4 treatment-emergent adverse events (TEAEs) were reported in 93.8% of patients.
    • Part 2: Voorhees et al (2023)9 reported the final efficacy and safety results after all patients completed ≥1 year of follow-up after the end of study treatment, died, or withdrew from study participation. The median follow-up was 49.6 months. In the D-VRd vs VRd group, respectively, sCR was achieved in 67% vs 48% of patients (OR, 2.18; 95% CI, 1.22-3.89; 2-sided P=0.0079) and complete response or better (≥CR) in 83% vs 60% of patients (P=0.0005). In the D-VRd vs VRd group, the most common (≥10%) grade 3/4 TEAEs were neutropenia (46% vs 23%), lymphopenia (23% in both groups), leukopenia (17% vs 8%), thrombocytopenia (16% vs 9%), pneumonia (12% vs 14%), and hypophosphatemia (10% vs 11%).
  • Costa et al (2023)10 reported the results from the final analysis of the MASTER study (N=123) at a median follow-up of 42.2 months. The overall MRD-negative remission rate (next-generation sequencing [NGS]; <10-5 threshold) in MRD-evaluable patients at any point in treatment was 81% (95% CI, 73-88). The 3-year PFS rates were 88% (95% CI, 78-95) for patients with standard risk (0 HRCA), 79% (95% CI, 67-88) for patients with high risk (1 HRCA), and 50% (95% CI, 30-70) for patients with ultra high-risk (≥2 HRCAs) cytogenetic abnormalities. The 3-year overall survival (OS) rates were 94% (95% CI, 88-98) for patients with 0 HRCA, 92% (95% CI, 86-96) for patients with 1 HRCA, and 75% (95% CI, 63-85) for patients with ≥2 HRCAs. The most common grade 3 TEAEs (≥5%) were neutropenia (29%), lymphopenia (15%), hypertension (11%), anemia (9%), fatigue (9%), thrombocytopenia (7%), hypophosphatemia (7%), bone pain (6%), and leukopenia (5%).
  • Other relevant literature is included in the References section for your information.11-15

PRODUCT LABELING

CLINICAL DATA

Phase 3 Study of DARZALEX FASPRO in Combination with VRd in TE NDMM

PERSEUS (MMY3014; NCT03710603) is a phase 3, randomized, open-label, multicenter study evaluating the efficacy and safety of D-VRd vs VRd induction and consolidation followed by maintenance with D-R in D-VRd group or R in VRd group in patients with NDMM eligible for ASCT.1

Primary Efficacy and Safety Analysis of the PERSEUS Study

Sonneveld et al (2023)1 reported efficacy and safety results from the PERSEUS study evaluating D-VRd vs VRd in patients with NDMM eligible for ASCT at a median follow-up of 47.5 months (range, 0-54.4).

Results

Patient Characteristics
  • A total of 709 patients were randomized into the D-VRd (n=355) and VRd (n=354) groups.1 
  • The baseline characteristics were well balanced between treatment arms.1
    • Across treatment arms, the median age was 60 years (range, 31-70), 14.8% of patients had International Staging System (ISS) stage III disease, and 21.7% had high cytogenetic risk (del[17p], t[4;14], or t[14;16]).
  • A total of 698 patients (D-VRd, n=351; VRd, n=347) received ≥1 dose of treatment.1
  • As of the clinical data cutoff date of August 1, 2023, 322 patients (91.7%) vs 300 patients (86.5%) in the D-VRd vs VRd group who started the induction therapy phase continued into the maintenance therapy phase.1
    • A total of 207/322 patients in the D-VRd group who were receiving maintenance therapy discontinued DARZALEX FASPRO per protocol after receiving ≥24 months of maintenance therapy, achieving ≥CR, and having sustained MRD-negativity for ≥12 months.
  • A total of 315 patients (89.7%) vs 302 patients (87.0%) in the D-VRd vs VRd group received ASCT.1
  • The median duration of treatment was 45.7 months (range, 0.5-54.3) in the D-VRd arm and 42.2 months (range, 0.1-53.9) in the VRd arm.1
Efficacy
  • A total of 50 patients (14.1%) vs 103 patients (29.1%) experienced disease progression or death in the D-VRd vs VRd group of the intention-to-treat (ITT) population (HR, 0.42; 95% CI, 0.30-0.59; P<0.0001), crossing the prespecified stopping boundary for superiority at the first interim analysis (P=0.0126).1
  • The estimated 48-month PFS rate for the D-VRd vs VRd group was 84.3% (95% CI, 79.5-88.1) vs 67.7% (95% CI, 62.2-72.6), respectively.1
  • Analyses of overall ≥CR rates and overall MRD-negativity rates (10-5) in prespecified subgroups appeared to favor D-VRd over VRd across clinically relevant subgroups.1
  • In the D-VRd group, 96.6% of patients achieved an overall response (95% CI, 94.2-98.2) vs 93.8% (95% CI, 90.7-96.1) in the VRd group, with 87.9% vs 70.1% (P<0.001) achieving ≥CR, respectively.1
  • In the D-VRd arm, 75.2% of patients were MRD-negative (10-5) compared with 47.5% of patients in the VRd arm (P<0.001).1
  • Prespecified subgroup analyses suggested consistent PFS benefit in the D-VRd arm as compared with the VRd arm across clinical subgroups, including patients with ISS stage III disease and those with high cytogenetic risk.1
Safety
  • The most common grade 3/4 AEs recorded in the D-VRd vs VRd group were neutropenia (62.1% vs 51.0%), thrombocytopenia (29.1% vs 17.3%), diarrhea (10.5% vs 7.8%), pneumonia (10.5% vs 6.1%), and febrile neutropenia (9.4% vs 10.1%). See Table: Most Common AEs During Treatment in the Safety Population.1
  • Grade 3/4 peripheral neuropathy occurred in 6.0% vs 4.9% of patients in the D-VRd vs VRd group, respectively.1
  • A second primary malignancy was observed in 37 patients (10.5%) in the D-VRd group and 25 patients (7.2%) in the VRd group.1
  • The number of deaths recorded due to COVID-19 in the D-VRd vs VRd group was 4 (1.1%) vs 1 (0.3%) patients, respectively.1
  • A total of 25.9% vs 54.2% of patients in the D-VRd vs VRd group discontinued treatment, respectively.1
    • The most common reasons for treatment discontinuation over all phases of the study were AEs (D-VRd, 9.1%; VRd, 22.5%) and progressive disease (PD; D-VRd, 8.3%; VRd, 20.7%).
  • A total of 34 vs 44 patients died in the D-VRd vs VRd group, respectively.1
    • A total of 7 patients died due to COVID-19 (D-VRd, n=4; VRd, n=3).

Most Common AEs During Treatment in the Safety Population1
Most Common (≥20%) Any Grade AEs
Most Common (≥10%) Grade 3/4 AEs
Hematologic
  • Neutropenia
  • Thrombocytopenia
  • Anemia

Nonhematologic
  • Diarrhea
  • Peripheral sensory neuropathy
  • Constipation
  • Pyrexia
  • Insomnia
  • Asthenia
  • Cough
  • Fatigue
  • Rash
  • Back pain
  • Peripheral edema
  • Nausea
  • Infections*
Hematologic
  • Neutropenia
  • Thrombocytopenia
  • Febrile neutropenia

Nonhematologic
  • Diarrhea
  • Infections**
Abbreviation: AE, adverse event.*Including COVID-19, upper respiratory tract infection, and pneumonia
**Including pneumonia
  • Serious AEs (SAEs) occurred in 57.0% vs 49.3% of patients in the D-VRd vs VRd arms, respectively. The most common SAEs (occurring in ≥2% of patients in either group) were16: 
    • Infections: 35.0% (D-VRd) vs 27.4% (VRd) 
      • Includes pneumonia, COVID-19, COVID-19 pneumonia, lower respiratory tract infection, sepsis, and upper respiratory tract infection.  
    • Febrile neutropenia: 4.6% (D-VRd) vs 4.6% (VRd) 
    • Pyrexia: 3.7% (D-VRd) vs 4.6% (VRd) 
    • Pulmonary embolism: 2.6% (D-VRd) vs 1.4% (VRd) 
    • Atrial fibrillation: 2.6% (D-VRd) vs 0.6% (VRd) 
    • Diarrhea: 2.0% (D-VRd) vs 2.6% (VRd)

Phase 3 Study of DARZALEX in Combination with VTd in TE NDMM

CASSIOPEIA (MMY3006; NCT02541383) is a phase 3, randomized, open-label, 2-group, multicenter study evaluating the safety and efficacy of D-VTd in patients with previously untreated MM who are eligible for HDT and ASCT.2,3

Final Analysis of the CASSIOPEIA Study

Moreau et al (2024)4 reported long-term outcomes of the CASSIOPEIA study after a median follow-up of 80.1 months from the first randomization and at a median follow-up of 70.6 months from the second randomization.

Study Design

  • During the induction and consolidation phases, efficacy assessments were conducted on the ITT population cohort, encompassing all patients from the first randomization.4
  • In the maintenance phase, efficacy analyses were performed on the maintenance-specific ITT population, including patients randomized during the second randomization.4

Results

Patient Disposition
  • Between September 22, 2015, and August 1, 2017, a total of 1085 patients were enrolled and randomized to receive D-VTd (n=543) and VTd (n=542).4
  • Overall, 458 patients (84%) in the D-VTd group and 428 patients (79%) in the VTd group, who completed consolidation and achieved a ≥PR, were re-randomized to either DARZALEX maintenance (n=442) or observation (n=444).4
    • At a clinical data cutoff of September 1, 2023, 339 patients (77%) had completed DARZALEX maintenance, and 317 patients (71%) had completed observation during the maintenance phase.
    • A total of 61 patients (14%) in the DARZALEX maintenance group and 118 patients (27%) in the observation group had discontinued treatment due to disease progression during the maintenance phase.
Efficacy

Summary of Long-term PFS and OS From First Randomization After a Median Follow-up of 80.1 Months4
Efficacy
D-VTd (n=543)
VTd (n=542)
Median PFS, months (95% CI)
83.7 (70.2-NE)
52.8 (47.5-58.7)
   HR (95% CI)
0.61 (0.52-0.72)
P value
<0.0001
PFS events
255
335
Median OS (95% CI)
NR (NE-NE)
NR (NE-NE)
   Estimated 72-month OS rate, % (95% CI)
86.7 (83.5-89.3)
77.7 (73.9-81.0)
OS, HR (95% CI)
0.55 (0.42-0.73)
P value
<0.0001
Abbreviations: CI, confidence interval; D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; HR, hazard ratio; NE, not estimable; NR, not reached; OS, overall survival; PFS, progression-free survival; VTd, bortezomib + thalidomide + dexamethasone.
  • A summary of efficacy data at a median follow-up of 70.6 months
    (IQR, 66.4-76.1) is presented in Table: Summary of Long-term PFS From Second Randomization After a Median Follow-up of 70.6 Months.4
    • PFS on the next line of therapy from second randomization was longer in the DARZALEX maintenance group than in the observation group (HR, 0.59; 95% CI, 0.45-0.79; P=0.0002) in the maintenance-specific ITT population.17
    • PFS on the next line of therapy from second randomization was longer in the VTd plus DARZALEX group than in the VTd plus observation group in the maintenance-specific ITT population17:
      • D-VTd plus DARZALEX vs D-VTd plus observation: HR, 1.01; 95% CI, 0.64-1.59; P=0.97.
      • VTd plus DARZALEX vs VTd plus observation: HR, 0.43; 95% CI, 0.30-0.62; P<0.0001.
      • No significant difference was observed in PFS on next line of therapy between the D-VTd plus DARZALEX group and the D-VTd plus observation group.

Summary of Long-term PFS From Second Randomization After a Median Follow-up of 70.6 Months4
Efficacy
DARZALEX Maintenance
Observation
D-VTd + DARZALEX Maintenance  
D-VTd + Observation
VTd + DARZALEX Maintenance  
D-VTd + Observation
PFS events
186
279
91
114
95
165
   PFS, HR
   (95% CI)
0.49 (0.40-0.59)
0.76 (0.58-1.00)
0.34 (0.26-0.44)
   P value
<0.0001
0.048
<0.0001
Median PFS, months (95% CI)
NR
(79.9-NE)
45.8
(41.8-49.6)
NR
(74.6-NE)
72.1
(52.8-NE)
NR
(66.9-NE)
32.7
(27.2-38.7)
Estimated
72-month PFS, % (95% CI)
57.1
(52.1-61.7)
36.5
(31.9-41.2)
60.3
(53.5-66.4)
50.5
(43.8-56.9)
53.7
(46.3-60.6)
20.8
(15.2-27.0)
Abbreviations: CI, confidence interval; D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; HR, hazard ratio; NE, not estimable; NR, not reached; PFS, progression-free survival; VTd, bortezomib + thalidomide + dexamethasone.

Best Response from Second Randomization by Induction/Consolidation and Maintenance Therapies in the Maintenance-Specific ITT Population17
Response Rates, %
DARZALEX
Observation
D-VTd
(n=229)
VTd
(n=213)
D-VTd
(n=229)
VTd
(n=215)
sCR
71.6
64.8
65.9
47.9
≥CR
76.9
70.0
72.1
49.8
CR
5.2
5.2
6.1
1.9
VGPR
16.6
28.2
21.8
40.0
PR
6.1
1.4
6.1
8.8
Abbreviations: CR, complete response; D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; ITT, intent-to-treat; PR, partial response; sCR, stringent complete response; VGPR, very good partial response; VTd, bortezomib + thalidomide + dexamethasone.

Proportion of Patients With a ≥CR and Sustained MRD-Negativity at Any Timepoint from Post-induction Onwards in the Maintenance-Specific ITT Population4
MRD Negativity Sensitivity Threshold
D-VTd
OR
(95% CI)
P Value
VTd
OR
(95% CI)
P Value
DARZALEX
(n=229)
Obs
(n=229)
DARZALEX
(n=213)
Obs
(n=215)
At any timepoint
   10-5, %
65.1
58.1
1.47
(0.95-2.26)
0.080
53.5
36.3
2.33
(1.51-3.60)
0.0001
   10-6, %
58.1
48.9
1.56
(1.04-2.34)
0.031
43.7
26.5
2.44
(1.56-3.81)
<0.0001
≥12 Months
   10-5, %
56.3
46.3
1.61
(1.08-2.41)
0.020
44.1
24.7
2.71
(1.73-4.23)
<0.0001
   10-6, %
47.6
36.2
1.68
(1.13-2.50)
0.0096
31.9
14.9
2.92
(1.77-4.82)
<0.0001
≥24 Months
   10-5, %
49.8
36.7
1.82
(1.23-2.71)
0.0028
36.2
16.7
3.15
(1.94-5.12)
<0.0001
   10-6, %
41.0
27.9
1.87
(1.25-2.81)
0.0023
24.9
10.2
3.11
(1.78-5.44)
<0.0001
Abbreviations: CR, complete response; D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; ITT, intent-to-treat; MRD, minimal residual disease; Obs, observation; OR, odds ratio; VTd, bortezomib + thalidomide + dexamethasone.

MRD-Negativity Rates at 10-5 Sensitivity Threshold Following Induction and Consolidation in the ITT Population17
Post-induction
Post-consolidation
D-VTd
(n=543)
VTd
(n=542)
D-VTd
(n=543)
VTd
(n=542)
MRD-negativity rate, %
9.2
5.4
33.7
20.3
   P value
0.015
<0.0001
Abbreviations: D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; ITT, intent-to-treat; MRD, minimal residual disease; VTd, bortezomib + thalidomide + dexamethasone.
  • A total of 85 (37%) of 229 patients in the D-VTd plus DARZALEX group and 75 (35%) of 213 patients in the VTd plus DARZALEX group, who were assigned to received DARZALEX-maintenance, also received subsequent antimyeloma therapy.4
  • Similarly, a total of 100 (44%) of 229 patients in the D-VTd plus observation group and 159 (74%) of 215 in the VTd plus observation group received subsequent antimyeloma therapy.4
  • Among those who received subsequent therapy, 61 (61%) of 100 patients in the D-VTd plus observation group and 108 (68%) of 159 patients in the VTd plus observation group received an anti-CD38-based first subsequent therapy, compared to 32 (38%) of 85 patients in the D-VTd plus DARZALEX group and 30 (40%) of 75 patients in the VTd plus DARZALEX group.4
  • The most frequently administered anti-CD38-based treatment regimen was DARZALEX, lenalidomide, and dexamethasone.4
Safety

Causes of Death During and After the Maintenance Phase by Induction/Consolidation Treatment in the Maintenance-Specific Safety Population17
Cause of Death, n (%)
DARZALEX
Observation
D-VTd
(n=229)
VTd
(n=211)
D-VTd
(n=229)
VTd
(n=215)
Total patients who died after 2nd randomization
25 (10.9)
41 (19.4)
21 (9.2)
48 (22.3)
Primary cause of death
   Adverse event
2 (0.9)
2 (0.9)
1 (0.4)
0
      Related to DARZALEX
0
1 (0.5)
0
0
      Unrelated
2 (0.9)
1 (0.5)
1 (0.4)
0
   Progressive disease
14 (6.1)
27 (12.8)
18 (7.9)
31 (14.4)
   Other
9 (3.9)
12 (5.7)
2 (0.9)
17 (7.9)
Abbreviations: D-VTd, DARZALEX + bortezomib + thalidomide + dexamethasone; VTd, bortezomib + thalidomide + dexamethasone.
  • Second primary malignancies occurred in the DARZALEX maintenance group (D-VTd, 11.4%; VTd, 12.3%) and the observation maintenance group (D-VTd, 6.1%; VTd, 10.2%).17

DARZALEX in Combination with Bortezomib, Lenalidomide, and Dexamethasone

GRIFFIN (MMY2004; NCT02874742) is a phase 2, randomized, open-label, multicenter, 2-part study evaluating the safety and efficacy of D-VRd in patients with NDMM eligible for HDT and ASCT.5-7

Final Analysis of Part 1 (Safety Run-in Phase) of the GRIFFIN Study

Voorhees et al (2021)8 reported the final analysis of the safety run-in cohort of the GRIFFIN study at a median follow-up of 40.8 months (range, 20.6-43.0) after patients completed D-VRd treatment and 24 months of D-R maintenance therapy.

Results

Baseline Characteristics

Baseline Characteristics (GRIFFIN Part 1)8
D-VRd
(n=16)
Age, years
   Median (range)
62.5 (46-65)
      <65 years, n (%)
14 (87.5)
      ≥65 years, n (%)
2 (12.5)
Sex, n (%)
   Male
8 (50.0)
   Female
8 (50.0)
Race, n (%)
   White
11 (68.8)
   Black or African American
4 (25.0)
   Asian
1 (6.3)
ECOG PS, n (%)a
   0
3 (18.8)
   1
10 (62.5)
   2
3 (18.8)
ISS disease stage, n (%)b
   I
12 (75.0)
   II
2 (12.5)
   III
2 (12.5)
Cytogenetic risk profile, n (%)c
   Standard
12 (75.0)
   High risk
4 (25.0)
Median (range) time since diagnosis of multiple myeloma, months
1.6 (0-5)
Abbreviations: D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, International Staging System.
aECOG PS is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability.
bISS disease stage is based on the combination of serum β2-microglobulin and albumin levels. Higher stages indicate more advanced disease.
cCytogenetic risk was assessed by fluorescence in situ hybridization (locally tested); high risk was defined as the presence of del(17p), t(4;14), or t(14;16) in those patients with cytogenetic risk data available.
  • All patients in the safety run-in phase (N=16) completed induction therapy, stem cell mobilization, ASCT, consolidation, and entered maintenance therapy.8
  • A total of 87.5% (n=14) of patients completed study therapy, and 2 (12.5%) discontinued the therapy because of PD (n=1) or AE (n=1; neuralgia or thrombocytopenia) during maintenance therapy.8
Safety
  • During cycle 1, 3/16 patients developed 4 dose-limiting toxicities (DLTs) fatigue, gastroenteritis, hypotension, and pneumonitis.8
    • All DLTs were grade 3 and none resulted in treatment discontinuation during induction or consolidation therapy.
  • One patient had a TEAE leading to discontinuation of study treatment.8
  • Fourteen (87.5%) patients experienced any grade infections, and 5 (31.3%) patients experienced grade 3/4 infections.8
    • During the maintenance phase 31.3% (n=5) of patients experienced any grade infections. (The most common being upper respiratory tract infections. One patient (6.3%) experienced a grade 3/4 infection (pneumonia and bronchitis).
  • Grade 1/2 IRRs occurred in 31.3% (n=5) of patients.8
    • IRRs included pruritus, chills, flushing, maculo-papular rash, and vascular access site swelling; all occurred during cycle 1 except vascular access site swelling.
  • An SAE occurred in 11 patients (68.6%).8
  • Eleven patients (68%) experienced an SAE. For the incidences of Grade 3/4 TEAEs, please see Table: Most Common Grade 3/4 TEAEs (GRIFFIN Part 1).8

Most Common Grade 3/4 TEAEs (GRIFFIN Part 1)8
Patients, n (%)
D-VRd (n=16)
Grade 3/4a
Total
15 (93.8)
Most commonly occurring
   Neutropenia
7 (43.8)
   Pneumonia
5 (31.3)
   Lymphopenia
5 (31.3)
   Thrombocytopenia
4 (25.0)
   Hypertension
3 (18.8)
Abbreviations: D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; TEAE, treatment-emergent adverse event.
aNo grade 5 TEAEs were reported.
Efficacy
  • At a median follow-up of 40.8 months, disease progression occurred in 3 patients.8
  • Median time to first response was 0.77 months (range, 0.1-2.1), and median duration of response was NE.8
  • Median time to ≥CR was 7.36 months (range, 2.8-18.5), and median duration of ≥CR was NE.8
  • Estimated 24-months PFS and OS rates was 93.8%.8
  • Estimated 36-month PFS and OS rates were 78.1% and 93.8%, respectively.8
  • MRD-negativity rates at 10-5 vs 10-6 sensitivity threshold8:
    • By end of D-VRd induction: 18.8% (n=3) vs 0%
    • By end of D-VRd consolidation: 50% (n=8) vs 0%
    • At the last follow-up: 81.3% (n=13) vs 31.3% (n=5)
  • MRD-negativity rates of 10-5 was sustained for ≥12 months in 8 (50.0%) patients.8
  • Response rates are presented in Table: Updated Response Rates Over Time for the Safety Run-in Cohort (GRIFFIN Part 1).8

Updated Response Rates Over Time for the Safety Run-in Cohort (GRIFFIN Part 1)a,8
Patients, %
By End of
D-VRd Induction
By End of
D-VRd Consolidation
By Last Follow-up
D-R Maintenance
sCR
-
56.3
93.8
CR
12.5
12.5
-
≥CR
12.5
68.8
93.8
VGPR
56.3
31.3
6.3
PR
31.3
-
-
Abbreviations: ≥CR, complete response or better; CR, complete response; D-R, DARZALEX + lenalidomide; D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.
Response data are shown for the response-evaluable population (N=16).
aPercentages do not add up to 100% due to rounding.

Final Analysis of Part 2 (Randomized Phase) of the GRIFFIN Study

Voorhees et al (2023)9 reported the final efficacy and safety results after all patients completed ≥1 year of follow-up after the end of study treatment, died, or withdrew from study participation at a median follow-up of 49.6 months (IQR, 47.4-52.1).

Results

Baseline Characteristics

Patient Demographics in the Randomized Phase (ITT; GRIFFIN Part 2)5
Characteristic
D-VRd
(n=104)
VRd
(n=103)
Age
   Median (range), years
59 (29-70)
61 (40-70)
   ≥65 years
28 (26.9)
28 (27.2)
Male, n (%)
58 (55.8)
60 (58.3)
ECOG PS,a n (%)
n=101
n=102
   0
39 (38.6)
40 (39.2)
   1
51 (50.5)
52 (51)
   2
11 (10.9)
10 (9.8)
ISS stage,b n (%)
   I
49 (47.1)
50 (48.5)
   II
40 (38.5)
37 (35.9)
   III
14 (13.5)
14 (13.6)
Baseline creatinine clearance, n (%)
   30-50 mL/minute
9 (8.7)
9 (8.7)
   >50 mL/minute
95 (91.3)
94 (91.3)
Cytogenetic profile,c n (%)
n=98
n=97
   Standard risk
82 (83.7)
83 (85.6)
   High risk
16 (16.3)
14 (14.4)
Time since diagnosis of MM
n=103
n=102
   Median (range), months
0.7 (0-12)
0.9 (0-61)
Abbreviations: D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, international staging system; ITT, intent-to-treat; MM, multiple myeloma; VRd, bortezomib + lenalidomide + dexamethasone.
aECOG PS is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability.
bISS disease stage is based on the combination of serum-β2-microglobulin and albumin levels. Higher stages indicate more advanced disease.
cCytogenetic risk was assessed by fluorescence in situ hybridization, high risk was defined as the presence of del17p, t((4:14), or t(14:16) among patients with available cytogenetic risk data.
  • By the final analysis, 25% of patients in the D-VRd group and 51% in the VRd group discontinued treatment.9
  • The median duration of treatment in the D-VRd and VRd groups was 32.5 months (IQR, 31.1-33.4) and 27.5 months (IQR, 2.9-32.7), respectively.9
    • In the D-VRd group, among the 90 patients who received DARZALEX and lenalidomide maintenance therapy, 21% (n=19) switched from DARZALEX to DARZALEX FASPRO and received ≥1 cycle of DARZALEX FASPRO (median number, 3.0 [IQR, 3.0-5.0]).
Efficacy
  • At the final analysis, among response-evaluable patients in the D-VRd (n=100) vs VRd (n=98) group, respectively, sCR was achieved in 67% vs 48% of patients (OR, 2.18; 95% CI, 1.22-3.89; 2-sided P=0.0079) and ≥CR in 83% vs 60% of patients (P=0.0005). Response data over time are summarized in Table: Summary of Response Over Time.9,18

Summary of Response Over Time9
Timepoint, %
D-VRd
VRd
sCR
CR
≥CR
VGPR
PR
SD/PD/
NE
sCR
CR
≥CR
VGPR
PR
SD/PD/
NE
End of inductiona
12
7
19
53
26
2
7
6
13
43
35
8
End of post-ASCT consolidationa
42
9
52
39
8
1
32
10
42
31
19
8
Final analysisb
67
16
83
13
3
1
48
12
60
17
14
8
Abbreviations: ≥CR, complete response or better; ASCT, autologous stem cell transplant; CR, complete response; D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; IQR, interquartile range; NE, not estimable; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response; VRd, bortezomib + lenalidomide + dexamethasone.
Rates shown are the number of patients with each type of response divided by the response-evaluable population.aResponse rates were from the primary analysis cutoff (median follow-up, 13.5 months) and the response-evaluable population comprised 196 patients (D-VRd, n=99; VRd, n=97). bResponse rates were also evaluated at the time of the final analysis (median follow-up 49.6 months; IQR 47.4-52.1), and the response-evaluable population comprised 198 patients (D-VRd, n=100; VRd, n=98).

Response Duration Among Patients in the D-VRd vs VRd Group9
Parameter
D-VRd
VRd
Median duration to first response (ORR), months (95% CI)
0.8 (0.8-0.8)
0.8 (0.8-1.0)
Median duration to sCR, months (95% CI)
10.2 (8.8-13.0)
14.3 (9.2-21.7)
   HR (95% CI)
1.26 (0.86-1.83)
   P value
0.2339
Median duration to ≥VGPR, months (95% CI)
2.2 (2.1-2.7)
3.0 (2.2-6.3)
Median duration to ≥CR, months (95% CI)
8.9 (7.9-9.4)
9.6 (8.4-12.2)
Median DOR
NR
NR
   Estimated 48-month DOR, % (95% CI)
89 (79.9-94.3)
71 (55.8-81.4)
Abbreviations: ≥CR, complete response or better; ≥VGPR, very good partial response or better; CI, confidence interval; DOR, duration of response; D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; NR, not reached; ORR, overall response rate; sCR, stringent complete response; VRd, bortezomib + lenalidomide + dexamethasone.

Final Analysis of Best Response and MRD-Negativity Rates at the End of Maintenance9,18
Parameter
D-VRd
VRd
P value
Response,a n
100
98
-
   ORR, n (%)
99 (99)
90 (92)
0.016b
      ≥CR
83 (83)
59 (60)
0.0005b
      CR
16 (16)
12 (12)
-
      sCR
67 (67)
47 (48)
0.0079b
      ≥VGPR
96 (96)
76 (78)
0.0002b
      VGPR
13 (13)
17 (17)
-
      PR
3 (3)
14 (14)
-
   SD, n (%)
1 (1)
8 (8)
-
   PD, n (%)
0
0
-
MRD-negative
   ITT population, n
104
103
-
      10-5 sensitivity, n (%)
67 (64)
31 (30)
<0.0001c
         OR (95% CI)
4.23 (2.35-7.62)
      10-6 sensitivity, n (%)
37 (36)
16 (16)
0.0013c
         OR (95% CI)
2.95 (1.52-5.75)
   In patients achieving ≥CR, n
83
59
-
      10-5 sensitivity, n (%)
64 (77)
28 (47)
0.0004c
      10-6 sensitivity, n (%)
35 (42)
14 (24)
0.031c
Durable MRD-negativity
   Lasting ≥12 months, n
104
103
-
      10-5 sensitivity, n (%)
46 (44)
14 (14)
<0.0001c
         OR (95% CI)
5.00 (2.50-9.99)
      10-6 sensitivity, n (%)
10 (10)
4 (4)
0.16c
         OR (95% CI)
2.48 (0.76-8.07)
Abbreviations: ≥CR, complete response or better; ≥VGPR, very good partial response or better; CI, confidence interval; CR, complete response; CrCl, creatinine clearance; D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; ISS, International Staging System; ITT, intent-to-treat; MM, multiple myeloma; MRD, minimal residual disease; OR, odds ratio; ORR, overall response rate; PD, progressive disease; PR, partial response; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response; VRd, bortezomib + lenalidomide + dexamethasone.The predefined per protocol final analysis occurred after all patients completed ≥1 year of long-term follow-up after the end-of-study treatment, died, or withdrew from study participation, whichever occurred first.aResponse rate is based on the response-evaluable population, which included randomized patients who had a confirmed diagnosis of MM, had measurable disease at baseline, received ≥1 dose of study treatment, and had ≥1 postbaseline disease assessment. The response-evaluable population for the primary analysis included 99 patients in the D-VRd group and 97 patients in the VRd group.bP value was calculated using the Cochran-Mantel-Haenszel Chi-square test stratified by ISS disease stage (I, II, or III) and baseline CrCl (30-50 mL/min or >50 mL/min) at randomization.cP value was calculated using Fisher’s exact test.
  • By the end of the 2-year maintenance therapy, 14% (n/N=15/104) and 10% (n/N=10/103) of patients in the D-VRd and VRd groups, respectively, who were previously MRD-positive at the end of the consolidation phase, converted to MRD-negative (10-5). MRD-negativity rates continuously improved over time and were consistently higher in the D-VRd vs VRd group. See Table: Summary of MRD-Negativity Rates Over Time (ITT Population).9,18

Summary of MRD-Negativity Rates Over Time (ITT Population)a,9,18
Timepoint, %
D-VRd
VRd
MRD-Negativity (10-5)
MRD-Negativity (10-6)
MRD-Negativity (10-5)
MRD-Negativity (10-6)
End of induction
22
1
8
0
Post-ASCT consolidation
50
11
20
3
End of study
64
36
30
16
Abbreviations: ASCT, autologous stem cell transplant; CR, complete response; D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; ITT, intent-to-treat; MRD, minimal residual disease; NGS, next-generation sequencing; sCR, stringent complete response; VRd, bortezomib + lenalidomide + dexamethasone. aMRD was evaluated by NGS using the clonoSEQ assay. MRD assessments occurred at the first evidence of suspected CR or sCR, after induction (but before stem cell collection), after consolidation, and after 12 and 24 months of maintenance, regardless of response.
  • No patient in either treatment group with sustained MRD-negativity 10-5 lasting ≥12 months became MRD-positive later.9
  • The median time to MRD-negativity in the D-VRd vs VRd group at sensitivity thresholds of 10-5 and 10-6, respectively, was 8.5 vs 34.6 months (HR, 2.70; 95% CI, 1.72-4.23; P<0.0001) and 33.9 months vs NR (HR, 1.93; 95% CI, 1.05-3.54; P=0.031).
  • Efficacy and survival outcomes are summarized in Table: Efficacy and Survival Outcomes (ITT Population).9,18

Efficacy and Survival Outcomes (ITT Population)9,18
Parameter
D-VRd
VRd
Median PFS, months
NR
NR
   3-year PFS rate, %
89
80.7
   4-year PFS rate, %
87.2
70
   PFS HR (95% CI); P value
0.45 (0.21-0.95); 0.032
Median PFS in patients who received lenalidomide therapy as per SoC after study completion, months
NR
NR
4-year PFS rate in patients who received SoC lenalidomide therapy after study completion, %
96
80
Median PFS in patients who did not receive lenalidomide therapy as per SoC after study completion, months
NR
NR
4-year PFS rate in patients who did not receive SoC lenalidomide therapy after study completion, %
100
86
Median OS, months
NR
NR
   3-year OS rate, %
92.7
92.2
   4-year OS rate, %
92.7
92.2
   OS HR (95% CI); P value
0.90 (0.31-2.56); 0.84a
Disease progression or death, n/N (%)
11/104 (11)
18/103 (17)
   HR (95% CI)
0.45 (0.21-0.95)
   P value
0.032
Abbreviations: CI, confidence interval; CrCl, creatinine clearance; D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; HR, hazard ratio; ISS, International Staging System; ITT, intent-to-treat; NR, not reached; OS, overall survival; PFS, progression-free survival; SoC, standard of care; VRd, bortezomib + lenalidomide + dexamethasone.
aHR and 95% CI are from a Cox proportional hazards model with treatment as the sole explanatory variable and stratified with ISS staging (I, II, and III) and baseline CrCl (30-50 mL/min or >50 mL/min) at randomization.An HR <1 indicates an advantage for D-VRd. P value is based on the log-rank test stratified with ISS staging and baseline CrCl at randomization.
Safety
  • Among safety-evaluable patients in the D-VRd (n=99) vs VRd (n=102) groups, grade 3/4 TEAEs occurred in 86% (n=85) vs 79% (n=81), respectively.9
  • In the D-VRd vs VRd group, serious TEAEs occurred in 46% (n=46) vs 52% (n=53) of patients, respectively.9
    • The most common serious TEAEs included pneumonia (15% vs 14%) and pyrexia (11% vs 10%).
  • TEAEs leading to treatment discontinuation were similar across treatment groups (D-VRd, 33% [n=33]; VRd, 31% [n=32]). One patient in each group died due to TEAEs unrelated to study treatment.9
  • Any-grade infections were more common in the D-VRd vs VRd group (93% [n=92] vs 66% [n=67]). Similar incidence rates were reported across treatment groups for grade 3/4 infections (D-VRd, 29%; VRd, 26%) and infections leading to treatment discontinuation (D-VRd, 2%; VRd, 3%).9
    • During maintenance therapy (cycle 7 and onwards) in the D-VRd vs VRd group, any-grade infections occurred in 35% (n/N=31/89) vs 32% (n/N=23/71) of patients and grade 3/4 infections occurred in 18% (n=16) vs 21% (n=15) of patients.
    • In the D-VRd vs VRd group, COVID-19 infections were reported in 5% (n=5) vs 2% (n=2) of patients, respectively. Of these, 1 patient in each group had a grade 3 COVID-19-related event (including 1 serious event in the D-VRd group).
  • TEAEs occurring in the safety population are summarized in Table: Most Common TEAEs in the Safety Population.9,18
  • During maintenance therapy, second primary malignancies with first onset after the start of maintenance therapy were reported in 4 of 89 (4%) evaluable patients in the D-VRd group and 3 of 71 (4%) evaluable patients in the VRd group.9
  • A total of 14 (D-VRd, n=7; VRd, n=7) patients died, of whom 9 (D-VRd, n=5; VRd, n=4) patients died due to PD.9
  • There were 39 [39%] IRRs reported at the initial infusion, 2 [2%] IRRs at the second infusion, and 14 [14%] IRRs at the subsequent infusions.18

Most Common TEAEs in the Safety Populationa,9,18
TEAEs, n (%)
D-VRd (n=99)
VRd (n=102)
Grade 1/2
Grade 3
Grade 4
Grade 1/2
Grade 3
Grade 4
Hematologic
   Anemia
28 (28)
9 (9)
0
27 (26)
5 (5)
1 (1)
   Thrombocytopenia
28 (28)
4 (4)
12 (12)
27 (26)
4 (4)
5 (5)
   Leukopenia
22 (22)
8 (8)
9 (9)
22 (22)
6 (6)
2 (2)
   Neutropenia
17 (17)
32 (32)
14 (14)
18 (18)
21 (21)
2 (2)
   Lymphopenia
8 (8)
13 (13)
10 (10)
6 (6)
20 (20)
3 (3)
Nonhematologic
   Hypokalemia
24 (24)
3 (3)
1 (1)
24 (24)
3 (3)
0
   Hypocalcemia
17 (17)
0
0
12 (12)
2 (2)
1 (1)
   Pneumoniab
11 (11)
11 (11)
1 (1)
4 (4)
14 (14)
0
   Hyperkalemia
6 (6)
1 (1)
0
1 (1)
0
1 (1)
   Cellulitis
6 (6)
0
1 (1)
3 (3)
1 (1)
0
   Hypophosphatemia
5 (5)
9 (9)
1 (1)
6 (6)
11 (11)
0
   Hyperuricemia
4 (4)
0
0
6 (6)
0
1 (1)
   Acute kidney injury
2 (2)
2 (2)
2 (2)
4 (4)
3 (3)
0
   Atrial fibrillation
1 (1)
0
1 (1)
3 (3)
0
0
   Increased blood creatine phosphokinase
1 (1)
0
0
0
0
1 (1)
   Atrial tachycardia
1 (1)
0
0
0
0
1 (1)
   Sepsis
0
1 (1)
2 (2)
0
1 (1)
0
   Drug reaction with eosinophilia and systemic symptoms
0
0
0
0
1 (1)
1 (1)
   Septic shock
0
0
0
0
0
1 (1)
   Cerebrovascular accident
0
0
0
0
0
1 (1)
   Systemic inflammatory
   response syndrome
0
0
0
0
0
1 (1)
   Death
0
0
0
0
0
0
IRRsc
49 (49)
7 (7)
0
-
-
-
Abbreviations: D-VRd, DARZALEX + bortezomib + lenalidomide + dexamethasone; IRR, infusion-related reaction; TEAE, treatment-emergent adverse event; VRd, bortezomib + lenalidomide + dexamethasone.
aThe maximum intensity for each preferred term is listed, and TEAEs are listed for all grade 4 or 5 events and any grade 3 events occurring in ≥10% of patients in either treatment group (corresponding grade 1-2 events are listed).
bOne grade 5 event was recorded in the D-VRd group.
cThere were no grade 4/5 IRRs. Data pertaining to IRRs are not available for the VRd group.

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 09 June 2026. In response to your specific request, summarized in this response is the relevant data from company-sponsored studies pertaining to this topic.​

 

References

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1 Sonneveld P, Dimopoulos MA, Boccadoro M, et al. Daratumumab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2024;390(4):301-313.  
2 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(10192):29-38.  
3 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.  
4 Moreau P, Hulin C, Perrot A, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol. 2024;25(8):1003-1014.  
5 Voorhees PM, Kaufman JL, Laubach J, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020;136(8):936-945.  
6 Voorhees PM, Kaufman J, Laubach J, et al. Daratumumab + lenalidomide, bortezomib & dexamethasone improves depth of response in transplant-eligible newly diagnosed multiple myeloma: GRIFFIN. Oral Presentation presented at: The 17th International Myeloma Workshop (IMW); September 12-15, 2019; Boston, MA.  
7 Voorhees PM, Costa L, Reeves B, et al. Interim safety analysis of a phase 2 randomized study of daratumumab (Dara), lenalidomide (R), bortezomib (V), and dexamethasone (d; Dara-RVd) vs RVd in patients (pts) with newly diagnosed multiple myeloma (MM) eligible for high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) (GRIFFIN). Poster presented at: The 59th American Society of Hematology (ASH) Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.  
8 Voorhees PM, Rodriguez C, Reeves B, et al. Daratumumab plus RVd for newly diagnosed multiple myeloma: final analysis of the safety run-in cohort of GRIFFIN. Blood Adv. 2021;5(4):1092-1096.  
9 Voorhees PM, Sborov DW, Laubach J, et al. Addition of daratumumab to lenalidomide, bortezomib, and dexamethasone for transplantation-eligible patients with newly diagnosed multiple myeloma (GRIFFIN): final analysis of an open-label, randomised, phase 2 trial. Lancet Haematol. 2023;10(10):e825-e837.  
10 Costa LJ, Chhabra S, Medvedova E, et al. Minimal residual disease response-adapted therapy in newly diagnosed multiple myeloma (MASTER): final report of the multicentre, single-arm, phase 2 trial. Lancet Haematol. 2023;10(11):e890-e901.  
11 Dimopoulos MA, Sonneveld P, Rodriguez-Otero P, et al. Daratumumab (DARA)/ bortezomib/lenalidomide/ dexamethasone (D-VRd) with D-R maintenance in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): analysis of PERSEUS based on cytogenetic risk. Poster presented at: The European Hematology Association (EHA) Hybrid Congress; June 13-16, 2024; Madrid, Spain.  
12 Rodriguez-Otero P, Voorhees PM, Boccadoro M, et al. Daratumumab for newly diagnosed multiple myeloma: pooled analysis of patients aged ≥65 years from GRIFFIN and PERSEUS. [Published online ahead of print April 11, 2025]. Clin Lymphoma Myeloma Leuk. 2025. doi:10.1016/j.clml.2025.04.007.  
13 Rodriguez-Otero P, Moreau P, Dimopoulos MA, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) with DARA-R (D-R) maintenance in transplant-eligible patients with newly diagnosed multiple myeloma (NDMM): analysis of minimal residual disease (MRD) in the PERSEUS trial. Oral Presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL, USA.  
14 Callander NS, Silbermann R, Kaufman JL, et al. Daratumumab-based quadruplet therapy for transplant-eligible newly diagnosed multiple myeloma with high cytogenetic risk. Blood Cancer J. 2024;14(1):69.  
15 Corre J, Vincent L, Moreau P, et al. Daratumumab/bortezomib/thalidomide/dexamethasone in newly diagnosed myeloma: CASSIOPEIA minimal residual disease results. [published online ahead of print March 24, 2025]. Blood. 2025. doi:10.1182/blood.2024027620.  
16 Sonneveld P, Dimopoulos MA, Boccadoro M, et al. Supplement to: Daratumumab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2023.  
17 Moreau P, Hulin C, Perrot A, et al. Supplement to: Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol. 2024;25(8):1003-1014.  
18 Voorhees PM, Sborov DW, Laubach J, et al. Supplement to: Addition of daratumumab to lenalidomide, bortezomib, and dexamethasone for transplantation-eligible patients with newly diagnosed multiple myeloma (GRIFFIN): final analysis of an open-label, randomised, phase 2 trial. Lancet Haematol. 2023;10(10):e825-e837.  

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