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CARVYKTI - Adverse Event - Hematologic Events

Last Updated: 03/13/2026

Summary

  • Johnson & Johnson does not recommend the use of CARVYKTI in a manner that is inconsistent with the approved labeling.
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • Hematologic adverse events (AEs) have been reported in the CARTITUDE-1, CARTITUDE-2 and CARTITUDE-4 studies.1-6
  • CARTITUDE-1 is a phase 1b/2, open label, multicenter study of CARVYKTI in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy (LOTs) including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-cluster of differentiation (CD) 38 monoclonal antibody (mAb).1,2,6
    • At a median follow-up of 61.3 months, no new hematologic AEs were reported.7,8
    • At a median follow-up of 33.4 months, the most common hematologic AEs (≥20%) of any grade that had occurred were neutropenia (96%), anemia (81%), thrombocytopenia (79%), leukopenia (62%), and lymphopenia (54%). Grade 3/4 hematologic AEs included neutropenia (95%), anemia (68%), leukopenia (61%), thrombocytopenia (60%), and lymphopenia (51%).2,6
  • CARTITUDE-2 is a phase 2, open-label, multicohort, single-arm, multicenter study evaluating CARVYKTI in patients with multiple myeloma (MM) in various clinical settings.9
    • Cohort A evaluates patients with RRMM who received 1-3 prior LOTs and are refractory to lenalidomide.10-14
      • Initial Subgroup: evaluated the efficacy and safety of CARVYKTI manufactured with the clinical trial process in 20 patients.10-13
        • At a median follow-up of 29.9 months, hematologic AEs of any grade were neutropenia (95%), thrombocytopenia (80%), lymphopenia (80%), anemia (75%), and leukopenia (60%). Grade 3/4 hematologic AEs included neutropenia (95%), lymphopenia (80%), leukopenia (60%), anemia (45%), and thrombocytopenia (40%).12
      • Expansion Subgroup: evaluated the efficacy and safety of CARVYKTI manufactured with a commercial process in 23 patients.14
        • At a median follow-up of 15.6 months, hematologic treatment-emergent adverse events (TEAEs) of any grade were neutropenia (95.7%), leukopenia (65.2%), lymphopenia (65.2%), anemia (56.5%), and thrombocytopenia (56.5%). Grade 3/4 hematologic TEAEs included neutropenia (95.7%), leukopenia (65.2%), lymphopenia (60.9%), anemia (39.1%), and thrombocytopenia (39.1%).14
    • Cohort B evaluates patients with early relapse (≤12 months after frontline therapy or ≤12 months after autologous stem cell transplant [ASCT]).4,15,16
      • At a median follow-up of 27.9 months (range, 5.2-32.1), hematologic AEs of any grade were neutropenia (94.7%), anemia (57.9%), thrombocytopenia (57.9%), lymphopenia (47.4%), and leukopenia (31.6%). Grade 3/4 hematologic AEs included neutropenia (89.5%), anemia (47.4%), lymphopenia (47.4%), leukopenia (31.6%), and thrombocytopenia (26.3%).12
    • Cohort C evaluates patients with RRMM with prior exposure to a PI, immunomodulatory drug, and an anti-CD38 mAb, and a B-cell maturation antigen (BCMA) bispecific antibody (BsAb) or antibody-drug conjugate (ADC).3,17
      • At a median follow-up of 18 months, the most common hematologic AEs (≥20%) of any grade in the ADC-exposed group were neutropenia (92%), anemia (77%), thrombocytopenia (69%), leukopenia (54%) and lymphopenia (46%). The most common hematologic AEs (≥20%) of any grade in the BsAb-exposed group were thrombocytopenia (100%), neutropenia (86%), anemia (57%), leukopenia (57%) and lymphopenia (29%).3
    • Cohort D evaluates patients with RRMM who achieved less than a complete response (<CR) after frontline ASCT, with or without lenalidomide maintenance.18,19
      • At a median follow-up of 40.2 months, no new hematologic AEs were reported.20
      • At a median follow-up of 22.4 months, hematologic treatment emergent adverse events (TEAEs) of any grade were neutropenia (94.1%), lymphopenia (64.7%), thrombocytopenia (47.1%), leukopenia (41.2%), and anemia (29.4%). Grade 3/4 hematologic TEAEs included neutropenia (82.4%), lymphopenia (58.8%), leukopenia (35.3%), thrombocytopenia (23.5%), and anemia (5.9%).19
  • CARTITUDE-4 is a phase 3, open-label, multicenter study evaluating CARVYKTI versus standard care regimens, DARZALEX FASPRO (daratumumab and hyaluronidase),pomalidomide, and dexamethasone (DPd) or pomalidomide, bortezomib, and dexamethasone (PVd), in patients with RRMM who received 1-3 prior LOTs, including a PI and an immunomodulatory drug, and are refractory to lenalidomide.5,21
    • AEs were evaluated in the safety population which included all patients who received any part of study treatment (n=208 in both the CARVYKTI and standard care arm).5,21
      • At a median follow-up of 33.6 months (interquartile range [IQR], 20.3-35.0), grade 3/4 cytopenias were the most frequently reported hematologic TEAEs in both arms.21
        • In the CARVYKTI arm, the most common grade 3 event was anemia, reported in 34.6% of patients (n=72) and the most common grade 4 event was neutropenia, reported in 73.1% of patients (n=152).22
        • In the standard‑care arm, neutropenia was the most common grade 3(28.4%; n=59) and grade 4 (53.8%; n=112) event.22
      • At a median follow-up of 15.9 months, the most common hematologic AEs (≥20%) of any grade in the CARVYKTI arm were neutropenia (89.9%), thrombocytopenia (54.3%), anemia (54.3%) and lymphopenia (22.1%). The most common hematologic AEs (≥20%) of any grade in the standard care arm were neutropenia (85.1%), thrombocytopenia (31.2%), and anemia (26.0%).5

PRODUCT LABELING

clinical data - CARTITUDE-1 - Phase 1b/2 study

CARTITUDE-1 (NCT03548207) was a phase 1b/2, open-label study evaluating the efficacy and safety of CARVYKTI in patients with RRMM after ≥3 prior LOTs including a PI, an immunomodulatory drug, and an anti-CD38 mAb.1,2,6

Study Design/Methods

  • Treatment arm: CARVYKTI (single arm)
  • Key eligibility criteria:
    • Progressive MM per International Myeloma Working Group criteria
    • ≥3 prior LOTs or double refractory to a PI and an immunomodulatory drug
    • Prior exposure to a PI, an immunomodulatory drug, and an anti-CD38 mAb
    • No prior exposure to CAR-T or BCMA targeting therapy
  • Primary endpoints: Recommended phase 2 dose, overall response rate

Results

Safety - Hematologic Adverse Events

CARTITUDE-1: Hematologic Adverse Events (≥20%)2
Event, n (%)
N=97
Any Grade
Grade 3/4
Neutropenia
93 (95.9)
92 (94.8)
Anemia
79 (81.4)
66 (68.0)
Thrombocytopenia
77 (79.4)
58 (59.8)
Leukopenia
60 (61.9)
59 (60.8)
Lymphopenia
52 (53.6)
49 (50.5)

CARTITUDE-1: Incidence and Recovery of Grade 3/4 Cytopenias2,23
Eventa
N=97
Incidence of Grade 3/4 Event After Day 1 of
CARVYKTI,
n

Recoveryb of Initial Grade 3/4 Event to Grade ≤2 by Day 30,
n (%)

Recovery of Initial Grade 3/4 Event to Grade ≤2 by Day 60,
n (%)

Lymphopenia
96
84 (87.5)c
88 (91.7)
Neutropenia
95
66 (69.5)d
85 (89.5)
Thrombocytopenia
60
20 (33.3)e
35 (58.3)
aBased on laboratory results.
bLaboratory results with the worst toxicity grade were used for a calendar day; recovery was defined as 2 consecutive grade ≤2 results from different days if the recovery period was ≤10 days.
cRecovery of grade 3/4 lymphopenia defined as the first incidence of lymphocytes count ≥0.5×109 cells/L after onset; recovery does not take into account treatment for grade 3/4 lymphopenia.
dRecovery of grade 3/4 neutropenia defined as the first incidence of neutrophils count ≥1000 cells/µL after onset; recovery does not take into account treatment for grade 3/4 neutropenia.
eRecovery of grade 3/4 thrombocytopenia defined as the first incidence of platelets count ≥50,000 cells/µL after onset; recovery does not take into account treatment for grade 3/4 thrombocytopenia.

clinical data - Cartitude-2 - Phase 2 Study

CARTITUDE-2 (NCT04133636) is an ongoing, phase 2, open-label, multicohort, single-arm, multicenter study evaluating the efficacy and safety of CARVYKTI in patients with MM in various clinical settings.9

  • Cohort A evaluates patients with RRMM who received 1-3 prior LOTs and are refractory to lenalidomide.10-14
    • Initial Subgroup: evaluated the efficacy and safety of CARVYKTI manufactured with the clinical trial process in 20 patients.10-13
    • Expansion Subgroup: evaluated the efficacy and safety of CARVYKTI manufactured with a commercial process in 23 patients.14
  • Cohort B evaluates patients with early relapse (≤12 months after frontline therapy or ≤12 months after ASCT).4,15,16
    • Early relapse was defined as progression within 12 months after ASCT or from start of anti-MM therapy for patients who have not had an ASCT.4,15,16
  • Cohort C evaluates patients with RRMM with prior exposure to a PI, immunomodulatory drug, and an anti-CD38 mAb, and a BCMA BsAb or ADC.3,17
  • Cohort D evaluates patients with RRMM who achieved <CR after frontline ASCT, with or without lenalidomide maintenance.18,19

Study Design/Methods

  • Treatment arm: CARVYKTI (single arm)
  • Key eligibility criteria:
    • No prior CAR-T cell therapy (cohorts A-D) or BCMA-targeted therapy (cohorts A, B, D)
    • Cohort A: 1-3 prior LOTs, including a PI and an immunomodulatory drug; lenalidomide refractory.9
    • Cohort B: 1 prior LOT, including a PI and an immunomodulatory drug; disease progression ≤12 months after ASCT or ≤12 months from other antimyeloma therapy.9
    • Cohort C: Previously treated with a PI, an immunomodulatory drug, an anti-CD38 mAb, and BCMA BsAb or ADC.9,17
    • Cohort D: History of 4-8 cycles of initial therapy, including induction, high-dose chemotherapy, and ASCT with or without consolidation, in patients with <CR after frontline ASCT.18,19
  • Primary endpoint: minimal residual disease negativity at the 10-5 sensitivity level as assessed by next-generation sequencing or next-generation flow.3,4,9,11,12,18,19,24

Results

Safety - Hematologic Adverse Events - Cohort A


CARTITUDE-2 (Cohort A) Initial Subgroup: Hematologic Adverse Events (≥20%)12
Event, n (%)
N=20
Any Grade
Grade 3/4
Neutropenia
19 (95.0)
19 (95.0)
Lymphopenia
16 (80.0)
16 (80.0)
Thrombocytopenia
16 (80.0)
8 (40.0)
Anemia
15 (75.0)
9 (45.0)
Leukopenia
12 (60.0)
12 (60.0)

CARTITUDE-2 (Cohort A) Expansion Subgroup: Hematologic TEAEs14
Event, n (%)
N=23
All
Grade 3 or 4
Hematologic
23 (100.0)
23 (100.0)
   Neutropenia
22 (95.7)
22 (95.7)
   Leukopenia
15 (65.2)
15 (65.2)
   Lymphopenia
15 (65.2)
14 (60.9)
   Anemia
13 (56.5)
9 (39.1)
   Thrombocytopenia
13 (56.5)
9 (39.1)
Abbreviation: TEAE, treatment-emergent adverse event.

Safety - Hematologic Adverse Events - Cohort B


CARTITUDE-2 (Cohort B): Hematologic Adverse Events (≥20%)12
Event, n (%)
N=19
Any Grade
Grade 3/4
Neutropenia
18 (94.7)
17 (89.5)
Lymphopenia
9 (47.4)
9 (47.4)
Thrombocytopenia
11 (57.9)
5 (26.3)
Anemia
11 (57.9)
9 (47.4)
Leukopenia
6 (31.6)
6 (31.6)
Safety - Hematologic Adverse Events - Cohort C

CARTITUDE-2 (Cohort C): Hematologic Adverse Events (≥20%)3
Eventa, n (%)
ADC-Exposedb (n=13)
BsAb-Exposedb (n=7)
Any Grades
Grade 3/4
Any Grades
Grade 3/4
Neutropenia
12 (92)
12 (92)
6 (86)
6 (86)
Anemia
10 (77)
7 (54)
4 (57)
4 (57)
Thrombocytopenia
9 (69)
8 (62)
7 (100)
6 (86)
Leukopenia
7 (54)
7 (54)
4 (57)
4 (57)
Lymphopenia
6 (46)
6 (46)
2 (29)
2 (29)
Abbreviations: ADC, antibody drug-conjugate; BCMA, B-cell maturation antigen; BsAb, bispecific antibody; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.
aAdverse events were graded using NCI-CTCAE v5.0.
bClassification is based on the last anti-BCMA therapy used if patients received more than 1 therapy.


CARTITUDE-2 (Cohort C): Patients with Initial Grade 3/4 Cytopenias Not Recovered to Grade ≤2 by Day 60 After CARVYKTI Infusion3
Event, %
Not Recovered by Day 60
ADC-Exposeda (n=13)
BsAb-Exposeda (n=7)
Thrombocytopenia
31
43
Neutropenia
23
0
Lymphopenia
23
0
Abbreviations: ADC, antibody drug-conjugate; BCMA, B-cell maturation antigen; BsAb, bispecific antibody.
aClassification is based on the last anti-BCMA therapy used if patients received more than 1 therapy.

Safety - Hematologic Adverse Events - Cohort D


CARTITUDE-2 (Cohort D): Hematologic TEAEs19
Event, n (%)
Cohort D
(N=17)

Any Grade
Grade 3/4
Neutropenia
16 (94.1)
14 (82.4)
Lymphopenia
11 (64.7)
10 (58.8)
Thrombocytopenia
8 (47.1)
4 (23.5)
Leukopenia
7 (41.2)
6 (35.3)
Anemia
5 (29.4)
1 (5.9)
Abbreviation: TEAE, treatment-emergent adverse event.

CARTITUDE-2 (Cohort D): Hematologic TEAEs Between Patients With or Without Lenalidomide Maintenance19
Event, n (%)
Cohort D
(N=17)

Cohort D Without  Lenalidomide (n=5)
Cohort D With
Lenalidomide (n=12)

Prolonged cytopeniasa
   Neutropenia
1 (5.9)
0
1 (8.3)
   Lymphopenia
5 (29.4)
2 (40.0)
3 (25.0)
   Thrombocytopenia
1 (5.9)
0
1 (8.3)
Abbreviations: TEAE, treatment-emergent adverse event.
a
Initial grade 3/4 cytopenias not recovered to grade ≤2 by day 60.

clinical data - CARTITUDE-4 - PHASE 3 STUDY

CARTITUDE-4 (NCT04181827) is a phase 3, randomized, open-label study evaluating the efficacy and safety of CARVYKTI versus standard care (physician's choice of PVd or DPd) in adult patients with lenalidomide-refractory MM after 1-3 prior LOTs.5

Study Design/Methods

  • Treatment arms: Randomized 1:1 to receive either CARVYKTI or standard care (DPd or PVd)
  • Key eligibility criteria
    • Received 1-3 prior LOTs including a PI and an immunomodulatory drug
    • Refractory to lenalidomide
    • No prior exposure to CAR-T or BCMA targeting therapy
  • Primary endpoint: Progression-free survival

Safety - Hematologic Adverse Events

Median follow-up of 33.6 months (IQR, 20.3-35.0)
  • No grade 5 hematological events were reported in both arms; grade 1/2, grade 3 and grade 4 hematologic TEAEs occurring in patients are detailed in Table: CARTITUDE 4: Hematological TEAEs.
    • In both treatment groups, grade 3/4 cytopenias were the most frequently reported hematologic TEAEs.21 
      • In the CARVYKTI arm, anemia was the most frequent grade 3 event reported in 34.6% of patients (n=72), and neutropenia was the most frequent grade 4 event reported in 73.1% of patients (n=152).22
      • In the standard care arm, neutropenia was the most frequent grade 3
        as well as grade 4 event reported in 28.4% of patients (n=59) and 53.8% of patients (n=112), respectively.22
  • Serious hematologic AEs occurring in ≥1% of patients in CARVYKTI vs standard-care arm included febrile neutropenia (2.4% [n=5] vs 2.9% [n=6]), anemia (1.9% [n=4] vs 0.5% [n=1]), and neutropenia (1.9% [n=4] vs 0.5% [n=1]).22 

CARTITUDE 4: Hematological TEAEs22,a
CARVYKTI (n=208)
Standard care (n=208)
Grade 1
or 2

Grade 3
Grade 4
Grade 1
or 2

Grade 3
Grade 4
Hematological events, n (%)
1 (0.5)
31 (14.9)
165 (79.3)
6 (2.9)
63 (30.3)
116 (55.8)
   Anemia
39 (18.8)
72 (34.6)
2 (1.0)
26 (12.5)
31 (14.9)
0 (0)
   Thrombocytopenia
26 (12.5)
39 (18.8)
48 (23.1)
26 (12.5)
30 (14.4)
11 (5.3)
   Lymphopenia
3 (1.4)
8 (3.8)
36 (17.3)
4 (1.9)
22 (10.6)
3 (1.4)
   Leukopenia
2 (1.0)
7 (3.4)
18 (8.7)
6 (2.9)
7 (3.4)
3 (1.4)
   Lymphocytosis
2 (1.0)
1 (0.5)
0 (0)
0 (0)
0 (0)
0 (0)
   Neutropenia
0 (0)
35 (16.8)
152 (73.1)
7 (3.4)
59 (28.4)
112 (53.8)
   Febrile neutropenia
0 (0)
8 (3.8)
3 (1.4)
0 (0)
8 (3.8)
1 (0.5)
   Cytopenia
0 (0)
1 (0.5)
0 (0)
0 (0)
0 (0)
0 (0)
   Immune
   thrombocytopenia

0 (0)
0 (0)
1 (0.5)
0 (0)
0 (0)
0 (0)
   Pancytopenia
0 (0)
0 (0)
1 (0.5)
0 (0)
1 (0.5)
0 (0)
   Hyperviscosity
   syndrome

0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1 (0.5)
Abbreviations: AE, adverse event; TEAE, treatment emergent adverse event.
aAEs are presented if they had a maximum grade of 1 or 2 and occurred in at least 10% of patients in either group, and also if they were any adverse event with a maximum grade of 3, 4, or 5. Events were included when they were considered by the investigator to be related to a study treatment or when they happened after the initiation of treatment, defined as apheresis in the CARVYKTI group and day 1 in the standard‑of‑care group. Events were collected up to 30 days after the last dose of a study treatment, before the initiation of subsequent therapy, or within 112 days after the CARVYKTI infusion for the CARVYKTI group only.

Median follow-up of 15.9 months (range, 0.1-27.3)
  • All grade hematologic AEs occurred in 94.7% of patients in the CARVYKTI arm vs 88.9% of patients in the standard care arm.5 
    • Grade 3/4 hematologic AEs occurred in 94.2% of patients in the CARVYKTI arm vs 86.1% of patients in the standard care arm.
  • In the CARVYKTI arm, the most common all grade hematologic AEs occurring in ≥20% of patients were neutropenia (89.9%), thrombocytopenia (54.3%), anemia (54.3%), and lymphopenia (22.1%).5
    • The most common grade 3/4 hematologic AEs occurring in ≥20% were neutropenia (89.9%), thrombocytopenia (41.3%), anemia (35.6%), and lymphopenia (20.7%).
  • In the standard care arm, the most common all grade hematologic AEs occurring in ≥20% of patients were neutropenia (85.1%), thrombocytopenia (31.2%), anemia (26%), and lymphopenia (13.9%).5 
    • The most common grade 3/4 hematologic AEs occurring in ≥20% were neutropenia (82.2%), thrombocytopenia (18.8%), anemia (14.4%), and lymphopenia (12.0%).
  • Of the patients who received CARVYKTI as study treatment (n=176), the incidence of grade 3/4 cytopenias included: lymphopenia, 100%; neutropenia, 94.9%; thrombocytopenia, 40.9%; and anemia, 29.5%.25
    • The incidence of prolonged (>30 days) grade 3/4 cytopenias included: lymphopenia, 29%; neutropenia, 26.1%; thrombocytopenia, 26.1%; and anemia, 1.7%.
    • The incidence of prolonged (>60 days) grade 3/4 cytopenias included: lymphopenia, 10.2%; neutropenia, 10.2%; thrombocytopenia, 10.8%; and anemia, 1.1%.  

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 05 March 2026.

 

References

1 Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324.  
2 Martin T, Usmani SZ, Berdeja JG, et al. Ciltacabtagene autoleucel, an anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy, for relapsed/refractory multiple myeloma: CARTITUDE-1 2-year follow-up. J Clin Oncol. 2022;41(6):1265-1274.  
3 Cohen AD, Mateos MV, Cohen Y, et al. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to non-cellular anti-BCMA immunotherapy. Poster presented at: 64th American Society of Hematology (ASH) Annual Meeting; December 10-13, 2022; New Orleans, LA/Virtual.  
4 van de Donk NWCJ, Agha M, Cohen A, et al. Ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in patients with multiple myeloma (MM) and early relapse after initial therapy: CARTITUDE-2 cohort B 18-month follow-up. Poster presented at: 64th American Society of Hematology (ASH) Annual Meeting; December 10-13, 2022; New Orleans, LA/Virtual.  
5 San-Miguel J, Dhakal B, Yong K, et al. Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med. 2023;389(4):335-347.  
6 Lin Y, Martin G, Usmani SZ, et al. CARTITUDE-1 final results: phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. Oral presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL/Virtual.  
7 Jagannath S, Martin TG, Lin Y, et al. Long-term (≥5-year) remission and survival after treatment with ciltacabtagene autoleucel in CARTITUDE-1 patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2025;43(25):2766-2771.  
8 Jagannath S, Martin TG, Lin Y, et al. Supplement to: Long-term (≥5-year) remission and survival after treatment with ciltacabtagene autoleucel in CARTITUDE-1 patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2025;43(25):2766-2771.  
9 Janssen Research & Development, LLC. A study of JNJ-68284528, a chimeric antigen receptor t cell (CAR-T) therapy directed against b-cell maturation antigen (BCMA) in participants with multiple myeloma (CARTITUDE-2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 March 05]. Available from: https://clinicaltrials.gov/ct2/show/NCT04133636 NLM Identifier: NCT04133636.  
10 Cohen Y, Cohen A, Delforge M, et al. Efficacy and safety of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy, in lenalidomide-refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy: updated results from CARTITUDE-2. Poster presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.  
11 Einsele H, Cohen A, Delforge M, et al. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel, a BCMA-directed CAR-T cell therapy, in lenalidomide-refractory patients with progressive multiple myeloma after 1-3 prior lines of therapy: CARTITUDE-2, Cohort A. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2022; Chicago, IL/Virtual.  
12 Hillengass J, Cohen AD, Agha M, et al. The phase 2 CARTITUDE-2 trial: updated efficacy and safety of ciltacabtagene autoleucel in patients with multiple myeloma and 1–3 prior lines of therapy (cohort A) and with early relapse after first line treatment (cohort B). Oral Presentation presented at: 65th American Society of Hematology (ASH) Annual Meeting and Exposition; December 9-12, 2023; San Diego, CA.  
13 Agha M, Cohen A, Madduri D, et al. CARTITUDE-2: efficacy and safety of ciltacabtagene autoleucel, a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma after 1-3 prior lines of therapy. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 4-8, 2021; Virtual.  
14 Cohen A, Voorhees P, Martin T, et al. Ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple myeloma: CARTITUDE-2 cohort A expansion subgroup. Poster presented at: American Society of Clinical Oncology; May 30 - June 4, 2024; Chicago, IL.  
15 Van de Donk NCWJ, Delforge M, Agha M, et al. CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in patients with multiple myeloma and early relapse after initial therapy. Poster presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.  
16 van de Donk NWCJ, Agha M, Cohen A, et al. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel, a BCMA-directed CAR-T cell therapy, in patients with multiple myeloma and early relapse after initial therapy: CARTITUDE-2, Cohort B. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2022; Chicago, IL/Virtual.  
17 Cohen A, Mateos M, Cohen Y, et al. Efficacy and safety of cilta-cel in patients with progressive MM after exposure to other BCMA-targeting agents. Blood. 2023;141(3):219-230.  
18 Einsele H, Van de Donk NCWJ, Arnulf B, et al. CARTITUDE-2 phase 2 multicohort study of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T (CAR-T) cell therapy, in patients with multiple myeloma (MM). Poster presented at: 7th World Congress on Controversies in Multiple Myeloma (COMy); May 7-9, 2021; Virtual meeting.  
19 Arnulf B, Kerre T, Agha M, et al. Efficacy and safety of ciltacabtagene autoleucel ± lenalidomide maintenance in newly diagnosed multiple myeloma with suboptimal response to frontline autologous stem cell transplant: CARTITUDE-2 Cohort D. Oral Presentation presented at: The American Society of Clinical Oncology (ASCO) Annual Meeting; May 31–June 4, 2024; Chicago, IL.  
20 Cohen Y, Kerre T, Delforge M, et al. Efficacy/safety of cilta-cel ± lenalidomide maintenance in patients with multiple myeloma who had suboptimal response to frontline ASCT: updated follow-up from CARTITUDE-2 cohort D. Poster presented at: International Myeloma Society (IMS) Annual Meeting; September 17-20, 2025; Toronto, Canada.  
21 Einsele H, San-Miguel J, Dhakal B, et al. Cilta-cel in lenalidomide-refractory multiple myeloma (CARTITUDE-4): an updated analysis including overall survival from an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2026;27(2):254-268.  
22 Einsele H, San-Miguel J, Dhakal B, et al. Supplement to: Cilta-cel in lenalidomide-refractory multiple myeloma (CARTITUDE-4): an updated analysis including overall survival from an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2026;27(2):254-268.  
23 Berdeja JG, Madduri D, Usmani SZ, et al. Supplement to: Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):1-277.  
24 Cohen AD, Cohen YC, Suvannasankha A, et al. Efficacy and safety of ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma and prior non-cellular anti-BCMA therapy: CARTITUDE-2 cohort C. Poster presented at: 20th International Myeloma Society (IMS) Annual Meeting; September 27-30, 2023; Athens, Greece.  
25 San-Miguel J, Dhakal B, Yong K, et al. Supplement to: Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med. 2023;389(4):335-347.