CEPHEUS Study Summary

Key eligibility criteria²

TIE or refused ASCT as initial therapy^*
<80 years of age
Myeloma frailty index score <2^†
ECOG PS score 0-2
CrCl ≥30 mL/min

Stratification factors²

ISS disease stage (I, II, or III)
Age/transplant eligibility:
- <70 years/TIE
- <70 years/refused ASCT as initial therapy
- ≥70 years

^*Patients were not considered candidates for high-dose chemotherapy with stem-cell transplantation due to aged (≥70 years) or age 18-70 years with the presence of underlying medical conditions likely to have a negative impact on tolerability of high-dose chemotherapy with stem-cell transplantation, making them transplant ineligible or refused high-dose chemotherapy with stem-cell transplantation as initial treatment (transplant deferred).

^†Total additive frailty is scored on a scale of 0 to 5 based on age, comorbidities, and cognitive and physical conditions, with 0 indicating fit, 1 indicating intermediate fitness, and ≥2 indicating frail, per the Myeloma Geriatric Assessment score.

Design: Open-label, randomized, active-controlled phase 3 study.^1,2

Objective: To evaluate the efficacy and safety of D-VRd vs VRd alone in patients with NDMM who are TIE or refused ASCT as initial therapy.¹

The effectiveness of DARZALEX FASPRO®-VRd has not been established in patients who refused autologous stem cell transplant as initial therapy.¹

^*First dose of the Q3W dosing schedule is given at Week 7.
^†First dose of the Q4W dosing schedule is given at Week 25.
^‡On the days of DARZALEX FASPRO® injection, the dexamethasone dose was administered orally or IV as a preinjection medication.

The median (range) duration of treatment was 56.3 months (0.1-64.6 months) for D-VRd and 34.3 months (0.5‑63.8 months) for VRd.²

Primary endpoint^1,2

Overall MRD-negativity (≥CR) rate at 10^-5 threshold^*†

Key secondary endpoints^1,2

Sustained MRD-negativity (≥CR) rate (≥12 months) at 10^-5‡
Overall ≥CR rate
ORR
PFS

^*Defined as the proportion of patients achieving ≥CR who had a MRD-negative status at or below a sensitivity threshold of 10^–5 after randomization but prior to disease progression, subsequent antimyeloma therapy, or both.

^†2-sided alpha of 0.05; 80% power was estimated to be needed to detect 15% improvement, or N=360.

^‡Defined as the proportion of patients who achieved ≥CR and MRD-negative status (10^-5) at two exams ≥1 year apart; the 2 exams should be prior to disease progression, subsequent antimyeloma therapy, or both, without MRD-positive status in between.

Patient demographics^1,2:

Characteristic	D-VRd (n = 197)	VRd (n = 198)
Age
Median (range), years	70 (42-79)	70 (31-80)
<65 years, n (%)	36 (18.3)	35 (17.7)
65 to <70 years, n (%)	52 (26.4)	53 (26.8)
≥70 years, n (%)	109 (55.3)	110 (55.6)
Age/transplant eligibility, n (%)
<70 years and TIE	35 (17.8)	35 (17.7)
<70 years and refused ASCT as initial therapy	53 (26.9)	53 (26.8)
≥70 years	109 (55.3)	110 (55.6)
*ECOG PS score,^ n (%)**
0	71 (36.0)	84 (42.4)
1	103 (52.3)	100 (50.5)
2	23 (11.7)	14 (7.1)
ISS disease stage,^† n (%)
I	68 (34.5)	68 (34.3)
II	73 (37.1)	75 (37.9)
III	56 (28.4)	55 (27.8)
Cytogenetic risk profile,^‡n (%)
Standard risk	149 (75.6)	149 (75.3)
High risk	25 (12.7)	27 (13.6)
Indeterminate	23 (11.7)	22 (11.1)
Type of measurable disease, n (%)
Detected in serum only	120 (60.9)	108 (54.5)
IgG	89 (45.2)	76 (38.4)
IgA	27 (13.7)	31 (15.7)
Other^§	4 (2.0)	1 (0.5)
Detected in serum and urine	41 (20.8)	45 (22.7)
Detected in urine only	20 (10.2)	24 (12.1)
Detected in serum FLC only	16 (8.1)	21 (10.6)
^*ECOG PS is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability. ^†ISS disease stage is based on the combination of serum β₂ microglobulin and albumin levels. Higher stages indicate more advanced disease. ^‡Cytogenetic risk was assessed by fluorescence in situ hybridization; high risk was defined as the presence of del(17p), t(4;14), or t(14;16). Indeterminate includes patients with missing or unevaluable samples. ^§Other includes IgD, IgM, IgE, and biclonal.

The study demonstrated a statistically significant improvement in overall MRD negativity rate and ≥CR rates at 22 months. The study demonstrated statistically significant improvement in PFS and sustained MRD at 39 months.¹

MRD negativity (10^-5) - Primary endpoint¹

In the CEPHEUS study, the overall MRD-negativity rate (10^-5) was 52.3% in the D-VRd arm and 34.8% in the VRd arm (P=0.0005)

^*Based on ITT population.

^†Patients achieved both MRD negativity (threshold of at or below 10^-5) and ≥CR. All MRD testing was performed with a next-generation sequencing assay (clonoSEQ).

^‡P value from Cochran Mantel-Haenszel Chi-Square test.

Additional efficacy outcomes¹

^*Based on ITT population.

^†Patients achieving MRD negativity (threshold of 10^-5 ) among only patients achieving a response of ≥CR.

^‡Exact 95% confidence interval.

^§P value from Cochran Mantel-Haenszel Chi-Square test.

Sustained MRD negativity rate (10^-5)¹

^*Based on ITT population.

^†Sustained MRD negativity is defined as confirmed MRD-negative status at two examinations at least 1 year apart without MRD-positive status in between.

^‡P value from Fisher’s exact test.

Progression-free survival¹

Treatment with D-VRd resulted in a reduction in the risk of progression or death by 40% vs VRd alone (HR=0.60; 95% CI: 0.41-0.88; P=0.0078)
The median PFS had not reached in either arm

Overall response rate¹

The subsequent analyses are not included in the Prescribing Information for DARZALEX FASPRO®. The endpoints overall MRD-negativity rate (10^-5) and sustained MRD-negativity rate (10^-5) were not adjusted for multiple comparisons and no conclusions should be drawn.

^*Based on ITT population.

^†OR calculated using the Mantel-Haenszel method stratified by ISS stage and age/transplant eligibility; OR >1 favors D-VRd.

^‡Sustained MRD negativity defined as ≥CR with MRD-negative status (≤10^-5) at 2 assessments ≥1 year apart, with no MRD-positive results in between. MRD was assessed from bone marrow using an NGS assay (clonoSEQ v2.0) per IMWG MRD guidelines.

Progression-free survival^2*

Treatment with D-VRd resulted in a reduction in the risk of progression or death by 43% vs VRd alone (HR=0.57; 95% CI: 0.41-0.79; P=0.0005)
The median PFS had not reached in the D-VRd treatment arm and was 52.6 months in the VRd treatment arm

^*Based on ITT population.

^†Final PFS analysis conducted after 162 events; 8 events were censored due to missing ≥2 consecutive disease evaluations.

^‡P value was calculated using the stratified log-rank test.

This subgroup analysis is not included in the Prescribing Information for DARZALEX FASPRO®. These analyses were conducted post hoc, and there are insufﬁcient numbers of patients per subgroup to make conclusions of efﬁcacy among the subgroups.

In this post hoc analysis, evaluating only the TIE subgroup population³:

Patients were randomized (1:1) to D-VRd or VRd³
In this analysis³:
- The primary endpoint was overall MRD-negativity (10^-5) rate (≥CR)
- Key secondary endpoints included sustained MRD-negativity rate and PFS

Characteristic	D-VRd (n = 144)	VRd (n = 145)
Age
Median (range), years	72.0 (58-79)	72.0 (51-80)
<70 years, n (%)	35 (24.3)	35 (24.1)
70 to <75 years, n (%)	68 (47.2)	65 (44.8)
≥75 years, n (%)	41 (28.5)	82 (56.6)
Sex, n (%)
Male	65 (45.1)	82 (56.6)
ECOG PS score,^† n (%)
0	52 (36.1)	57 (39.3)
1	75 (52.1)	78 (53.8)
2	17 (11.8)	10 (6.9)
IMWG frailty score, n (%)^‡
0 (fit)	82 (56.9)	88 (60.7)
1 (intermediate fitness)	62 (43.1)	57 (39.3)
IFM frailty score, n (%)
Nonfrail (0-1)	96 (66.7)	110 (75.9)
Frail (≥2)	48 (33.3)	35 (24.1)
Type of myeloma by immunofixation or serum FLC assay, n (%)
IgG	92 (63.9)	78 (53.8)
IgA	26 (18.1)	42 (29.0)
IgD	2 (1.4)	2 (1.4)
Light chain	20 (13.9)	19 (13.1)
Biclonal	4 (2.8)	3 (2.1)
Unknown	0	1 (0.7)
Extramedullary plasmacytomas, n (%)	9 (6.3)	12 (8.3)
ISS staging, n (%)^§
I	50 (34.7)	48 (33.1)
II	54 (37.5)	57 (39.3)
III	40 (27.8)	40 (27.6)
Cytogenetic risk,^I n (%)
Standard risk	105 (72.9)	111 (76.6)
High risk	20 (13.9)	18 (12.4)
Unevaluable or missing	19 (13.2)	16 (11.0)
^Based on the TIE subgroup population ^†ECOG PS is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability. ^‡Total additive frailty is scored on a scale of 0 to 5 based on age, comorbidities, and cognitive and physical conditions, with 0 indicating fit, 1 indicating intermediate fitness, and ≥2 indicating frail, per the Myeloma Geriatric Assessment score. ^§Based on the combination of serum β₂ microglobulin and albumin levels. Higher stages indicate more advanced disease. ^IBased on fluorescence in situ hybridization; high risk was defined as the presence of del(17p), t(4;14), and/or t(14;16)*.

At a median follow-up of 59 months, this subgroup analysis showed overall MRD-negativity (10^-5) rate of 60.4% in the D-VRd arm and 39.3% in the VRd arm (OR, 2.37; 95% CI, 1.47-3.80).³

^*Median follow-up of 59 months

^†MRD-negativity rate was defined as the proportion of patients who achieved both MRD negativity (10^-5) and ≥CR.

^‡Sustained MRD negativity was defined as 2 consecutive MRD negative reads ≥12 months (±1) or 24 months (±3) apart with no MRD-positive result in between.

At a median follow-up of 59 months, median PFS was not reached for D-VRd and 49.6 months for VRd, and the 54-month PFS rate was 69.0% vs 48.0% (HR, 0.51; 95% CI, 0.35-0.74).³

The most common adverse reactions (>20%) included¹:

Upper respiratory tract infection
Sensory neuropathy
Musculoskeletal pain
Diarrhea
Fatigue
Edema
Rash

Motor dysfunction
COVID-19
Constipation
Sleep disorder
Cough
Pneumonia
Renal impairment

Dizziness
Nausea
Urinary tract infection
Pyrexia
Abdominal pain
Dyspnea
Decreased appetite
Bruising

Adverse reaction	D-VRd (n = 197)		VRd (n = 195)
Adverse reaction	All grades (%)	Grade 3 or 4 (%)	All grades (%)	Grade 3 or 4 (%)
Infections
Upper respiratory tract infection^*	75	4^#	63	3^#
COVID-19^†	39^**	9	25^**	3
Pneumonia^‡	31^**	16	26^**	15
Urinary tract infection^†	24	4^#	17	3^#
Nervous system disorders
Sensory neuropathy^§	72	12^#	72	10
Motor dysfunction^I	44	11^#	37	7^#
Dizziness^†	26	2^#	26	1^#
Musculoskeletal and connective tissue disorders
Musculoskeletal pain^†	62	9^#	61	7^#
Gastrointestinal disorders
Diarrhea^†	57	12^#	59	9^#
Constipation	38	2^#	42	3^#
Nausea	25	0	25	2^#
Abdominal pain^†	23^**	1	17	2^#
General disorders and administration site conditions
Fatigue^†	56	14^#	53	11^#
Edema^†	54	4^#	46	2^#
Pyrexia^†	24	1^#	16	1^#
Skin and subcutaneous tissue disorders
Rash^†	50	8^#	47	7
Psychiatric disorders
Sleep disorder^†	33	3^#	33	2^#
Respiratory, thoracic and mediastinal disorders
Cough^†	32	1^#	21	1^#
Dyspnea^†	21^**	2	17	1^#
Renal and urinary disorders
Renal impairment^¶	26	7	25	6
Metabolism and nutrition disorders
Decreased appetite	21	1^#	20	3^#
Injury, poisoning and procedural complications
Bruising^†	20	0	12	0
^Upper respiratory tract infection includes acute sinusitis, influenza, influenza like illness, laryngitis, nasal congestion, nasopharyngitis, parainfluenzae virus infection, pharyngitis, pharyngitis streptococcal, respiratory syncytial virus infection, respiratory tract infection, respiratory tract infection viral, rhinitis, rhinovirus infection, sinus congestions, sinus disorder, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection, and viral upper respiratory tract infection ^†Includes other related terms. ^‡Pneumonia includes bronchopulmonary aspergillosis, COVID-19 pneumonia, lower respiratory tract infection, Pneumocystis jirovecii pneumonia, pneumonia, pneumonia aspiration, pneumonia bacterial, pneumonia cryptococcal, pneumonia influenza, pneumonia klebsiella, pneumonia legionella, pneumonia pneumococcal, pneumonia respiratory syncytial viral, pneumonia viral, and tuberculosis. ^§Sensory neuropathy includes anosmia, burning sensation, dysesthesia, hyperesthesia, hyperesthesia teeth, hypoesthesia, hypoesthesia oral, neuralgia, neuropathy peripheral, oral dysesthesia, palmar-plantar erythrodysesthesia syndrome, paresthesia, paresthesia oral, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, and skin burning sensation. ^IMotor dysfunction includes balance disorder, essential tremor, extrapyramidal disorder, facial paralysis, gait disturbance, hypotonia, mobility decreased, motor dysfunction, muscle contractions involuntary, muscle contracture, muscle spasms, muscular weakness, myopathy, paraparesis, peripheral motor neuropathy, peroneal nerve palsy, pharyngeal paresthesia, and tremor. ^¶Renal impairment includes acute kidney injury, blood creatinine increased, chronic kidney disease, creatinine renal clearance decreased, glomerular filtration rate decreased, prerenal failure, renal failure, renal impairment, and renal injury. ^#Only grade 3 adverse reactions occurred. ^*Fatal adverse reactions occurred for abdominal pain: n=1 (1%) in the D-VRd arm; COVID-19: n=7 (4%) in the D-VRd arm and n=5 (3%) in the VRd arm; pneumonia: n=8 (4%) in the D-VRd arm and n=5 (3%) in the VRd arm; dyspnea: n=1 (1%) in the D-VRd arm.

The most frequent SAEs in >5% of patients who received D-VRd were¹:

Fatal adverse reactions occurred in 16.8% of patients who received D-VRd¹
Fatal adverse reactions that occurred in more than 1 patient included¹:

Permanent treatment discontinuation due to an adverse reaction occurred in 8% of patients who received D-VRd¹
An adverse reaction, which resulted in permanent discontinuation of D-VRd in more than 1 patient included pneumonia¹

This data is not included in the Prescribing Information of DARZALEX FASPRO®.

	D-VRd (n = 144)	VRd (n = 142)
Any TEAE, n (%)	144 (100)	142 (100)
Any grade 3 or 4 TEAE	115 (79.9)	113 (79.6)
Grade 5 non-COVID-19 TEAE	13 (9.0)	12 (8.5)
Grade 5 COVID-19^* TEAE	6 (4.2)	1 (0.7)
Any serious TEAE	104 (72.2)	99 (69.7)
TEAE leading to discontinuation of all study treatment	11 (7.6)	27 (19.0)
Total deaths during study	33 (22.9)	46 (32.4)
Exposure-adjusted grade 5 TEAE rate, patient-months	0.27/100	0.31/100
Second primary malignancies	14 (9.7)	16 (11.3)

Grade 3 or 4 TEAE, n (%)	D-VRd (n = 144)	VRd (n = 142)
Neutropenia	63 (43.8)	45 (31.7)
Thrombocytopenia	44 (30.6)	33 (23.2)
Anemia	18 (12.5)	18 (12.7)
Diarrhea	17 (11.8)	14 (9.9)
Fatigue	13 (9.0)	15 (10.6)
COVID-19^†	14 (9.7)	5 (3.5)
Pneumonia	20 (13.9)	17 (12.0)
Peripheral sensory neuropathy	Any grade: 86 (59.7) grade 3 or 4: 14 (9.7)	Any grade: 90 (63.4) grade 3 or 4: 12 (8.5)

^*Deaths on or within 30 days of treatment
^†Group term. D-VRd, daratumumab, bortezomib, lenalidomide, and dexamethasone

Contraindications¹:

DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.

Warnings and precautions¹:

Please see the full prescribing information for more details.

Hypersensitivity and other administration reactions

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®
Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®

Systemic Reactions

In a pooled safety population of 1446 patients with multiple myeloma (n = 1253) or light chain (AL) amyloidosis (n = 193) who received DARZALEX FASPRO® as monotherapy or as part of a combination therapy, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3%, Grade 3: 0.8%, Grade 4: 0.1%)
In all patients, (n = 1639), systemic administration-related reactions occurred in 7% of patients with the first injection, 0.5% with the second injection, and cumulatively 1% with subsequent injections
The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days)
Of the 283 systemic administration-related reactions that occurred in 135 patients, 240 (85%) occurred on the day of DARZALEX FASPRO® administration
Delayed systemic administration-related reactions have occurred in 1% of the patients

Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma
Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids
Monitor patients for systemic administration-related reactions, especially following the first and second injections
For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®
Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration‑related reactions

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products
If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®

Local Reactions

In this pooled safety population of 1446 patients with multiple myeloma (n = 1253) or light chain (AL) amyloidosis (n = 193), injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 1.1%
The most frequent (>1%) injection-site reaction was injection-site erythema and injection site rash
In patients with high-risk smoldering multiple myeloma (N = 193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%
These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®
Monitor for local reactions and consider symptomatic management

Infections

DARZALEX FASPRO® can cause serious, life-threatening, or fatal infections
In patients who received DARZALEX FASPRO® in a pooled safety population including patients with smoldering multiple myeloma and light chain amyloidosis (n = 1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%
The most common type of serious infection reported was pneumonia (8.5%)
Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX FASPRO® and treat appropriately
Administer prophylactic antimicrobials according to guidelines

Neutropenia

Daratumumab may increase neutropenia induced by background therapy
Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies
Monitor patients with neutropenia for signs of infection
Consider withholding DARZALEX FASPRO® until recovery of neutrophils
In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy
Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies
Consider withholding DARZALEX FASPRO® until recovery of platelets

Embryo-fetal toxicity

Based on the mechanism of action, DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman
DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density
Advise pregnant women of the potential risk to a fetus
Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO® and for 3 months after the last dose
The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child
Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy

Interference with serological testing

Daratumumab binds to CD38 on RBCs and results in a positive indirect antiglobulin test (indirect Coombs test)
Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration
Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum
The determination of a patient’s ABO and Rh blood type are not impacted
Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®
Type and screen patients prior to starting DARZALEX FASPRO®

Interference with determination of complete response

Daratumumab is a IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M‑protein
This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein

Adverse reactions

In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection
The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, sleep disorder, headache, rash, renal impairment, motor dysfunction, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, decreased appetite, urinary tract infection, abdominal pain, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, dizziness, bruising, and COVID-19
The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin

DARZALEX FASPRO® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Usmani SZ, Facon T, Hungria V, et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS study. Nat Med. 2025;31:1195-1202. doi.org/10.1038/s41591-024-03485-7
Usmani SZ, Facon T, Zweegman S, et al., Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. Presented at: the American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL.
Meeting of the Oncologic Drugs Advisory Committee (ODAC). April 12, 2024. Accessed March 4, 2026. Available at: https://tinyurl.com/2tbe3f4k

ASCT	autologous stem cell transplant	NE	not estimable
BMI	body mass index	ODAC	Oncologic Drugs Advisory Committee
CI	confidence interval	OR	odds ratio
COVID-19	coronavirus disease 2019	ORR	overall response rate
CR	complete response	PFS	progression-free survival
CrCl	creatinine clearance	PO	oral
D	daratumumab and hyaluronidase-fihj	PR	partial response
d	dexamethasone	QW	every week
D-VRd	daratumumab and hyaluronidase-fihj plus bortezomib/lenalidomide/dexamethasone	Q3W	every 3 weeks
ECOG PS	Eastern Cooperative Oncology Group performance status	Q4W	every 4 weeks
FDA	US Food and Drug Administration	R	lenalidomide
FLC	free light chain	RBC	red blood cell
HR	hazard ratio	SAE	serious adverse event
IFM	Intergroupe Francophone du Myelome	SC	subcutaneous
Ig	immunoglobulin	sCR	stringent complete response
IMWG	International Myeloma Working group	TEAE	treatment-emergent adverse event
ISS	International Staging System	TIE	transplant ineligible
ITT	intent-to-treat	V	bortezomib
IV	intravenous	VGPR	very good partial response
MRD	minimal residual disease	VRd	bortezomib/lenalidomide/dexamethasone
NDMM	newly diagnosed multiple myeloma