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TECVAYLI® (teclistamab-cqyv)
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TECVAYLI - MajesTEC-4 Study

Last Updated: 07/06/2026

Summary

  • Johnson & Johnson does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by regulatory agencies.
  • MajesTEC-4 is an open-label, randomized, multicenter, phase 3 study assessing the efficacy and safety of TECVAYLI in combination with lenalidomide (Tec-Len) and TECVAYLI alone vs lenalidomide alone as maintenance therapy after autologous stem cell transplant (ASCT) in patients with newly diagnosed multiple myeloma (NDMM).1-3
    • van de Donk et al (2026)1 presented updated efficacy and safety results from the safety run-in (SRI), including cohort 1 (Tec-Len; TECVAYLI [QW] to every 4 weeks [Q4W]), cohort 2 (Tec-Len; TECVAYLI Q4W), and cohort 3 (TECVAYLI Q4W), with up to 3 years of median follow-up.
    • Zamagni et al (2024)2 presented the preliminary efficacy and safety results from the SRI of cohort 1 at a median follow-up of 21.1 months (range, 14.8-23.8), cohort 2 at a median follow-up of 9.2 months (range, 1.2-12.2), and cohort 3 at a median follow-up of 9.2 months (range, 3.7- 11.5).

CLINICAL DATA - MAJESTEC-4 STUDY

MajesTEC-4 (EMN30; NCT05243797) is an open-label, randomized, multicenter, phase 3 study evaluating the efficacy and safety of Tec-Len and TECVAYLI alone vs lenalidomide alone as maintenance therapy in patients with NDMM.1,2

Study Design/Methods

  • The study design is presented in the Figure: MajesTEC-4/EMN30 Study Design.
  • An SRI period consisting of 3 cohorts was used to establish safety prior to enrolling the randomized phase of the study.2
  • Maintenance regimen (2-year fixed duration): patients who achieved complete response (CR) on Tec-Len after 1-year discontinued TECVAYLI and continued lenalidomide for an additional year.2

MajesTEC-4/EMN30 Study Design1-3

Abbreviations: ASCT, autologous hematopoietic stem cell transplantation; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell therapy; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; EMN, Stichting European Myeloma Network; IMWG, International Myeloma Working Group; Len, lenalidomide; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; NGF, next-generation flow cytometry; NK, natural killer; OS, overall survival; PI, proteasome inhibitor; PFS, progression-free survival; PFS2, progression-free survival after next line of therapy, PK, pharmacokinetics; PR, partial response; Q4W, every 4 weeks; Q2W, every other week; QW, weekly; SRI, safety run-in; SUD, step-up dosing; Tec, teclistamab; Tec-Len, teclistamab + lenalidomide; TTNT, time to next treatment; VGPR, very good partial response.
aPI and/or immunomodulatory drug ± anti-CD38 antibody.
bSingle or tandem ASCT permitted.
cPatients received step-up doses of 0.06 and 0.3 mg/kg in day 1 and day 3.
dReceived on days 8, 15, and 22.
eStarted at 10 mg/day during cycles 2-4 in a 28-day cycle, increasing to 15 mg/day in cycles 5-26 if tolerated.
fPatients who achieved ≥CR on Tec-Len after cycle 13 discontinued Tec.
gReceived on days 8 and 15.

van de Donk et al (2026)1 presented updated efficacy and safety results from the SRI, including cohort 1 (Tec-Len; TECVAYLI [QW] to Q4W), cohort 2 (Tec-Len; TECVAYLI Q4W), and cohort 3 (TECVAYLI Q4W), with up to 3 years of median follow-up.

Results

Treatment Disposition


MajesTEC-4/EMN30 Study (SRI): Demographics and Disease Characteristics1,2
Characteristic
Cohort 1
Tec-Len (QW to Q4W)
(n=32)
Cohort 2
Tec-Len (Q4W)
(n=32)
Cohort 3
Tec (Q4W)
(n=30)
Median age, years (range)
58.5 (31-73)
58 (38-73)
58.5 (34-72)
   ≥65, n (%)
12 (37.5)
5 (15.6)
9 (30)
Male, n (%)
21 (65.6)
21 (65.6)
22 (73.3)
White race, n (%)
32 (100)
32 (100)
30 (100)
ISS disease stage at diagnosis, n (%)
   I
18 (56.3)
7 (21.9)
9 (32.1)a
   II
7 (21.9)
10 (31.3)
11 (39.3)a
   III
7 (21.9)
15 (46.9)
8 (28.6)a
High cytogenetic risk at diagnosisb, n (%)
7 (28.0)c
5 (17.2)d
6 (24.0)c
ECOG PS
0-1
0-1
0-1
Induction regimen for MM, n (%)
   PIe + immunomodulatory drugf
28 (87.5)
28 (87.5)
30 (100)
   PIe + immunomodulatory drugf +
   anti-CD38g
11 (34.4)
19 (59.4)
20 (66.7)
Prior consolidation, n (%)
6 (18.8)
12 (37.5)
10 (33.3)
Median time from ASCT to enrollment, months (range)
4.3 (2-6.2)
5.1 (1.8-7.4)
4.5 (2.1-6.9)
Abbreviations: ASCT, autologous stem-cell transplant; ECOG PS, Eastern Cooperative Oncology Group performance status; EMN, Stichting European Myeloma Network; ISS, International Staging System; Len, lenalidomide; MM, multiple myeloma; PI, proteasome inhibitor; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide.
aEvaluated in 28 patients.
bPresence of ≥1 of the following abnormalities: del(17p), t(4;14), or t(14;16).
cEvaluated in 25 patients.
dEvaluated in 29 patients.
eOut of 94 patients in all 3 SRI cohorts, 93 patients (98.9%) received bortezomib and 3 patients (3.2%) received carfilzomib.
fOut of 94 patients in all 3 SRI cohorts, 53 patients (56.4%) received len, 39 patients (41.5%) received thalidomide, and 1 patient (1.1%) received pomalidomide.
gOut of 94 patients in all 3 SRI cohorts, 49 patients (52.1%) received daratumumab and 1 patient (1.1%) received isatuximab as part of a triplet regimen; 1 patient (1.1%) received daratumumab with len as part of a doublet regimen.

MajesTEC-4/EMN30 Study (SRI): Treatment Disposition and Exposure1
Parameter, n
Cohort 1
Tec-Len (QW to Q4W)
(n=32)
Cohort 2
Tec-Len (Q4W)
(n=32)
Cohort 3
Tec (Q4W)
(n=30)
Treatment discontinuation reason, n
   AEs
5
5
1
   Patient decision
3
-
2
   Progressive disease
2
-
1
Completed treatment, n
14
7
0
Still on treatment, n
8
20
26
Abbreviations: AE, adverse event; EMN, Stichting European Myeloma Network; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide.
Note: Median follow-up time: cohort 1, 32.7 months (range, 14.8-35.3); cohort 2, 21.2 months (range, 1.2 [censored observation]-24.8), cohort 3, 21.2 months (range, 3.7-24.0). Safety data cutoff date: September 17, 2025.

Efficacy


MajesTEC-4/EMN30 Study (SRI): Response Rates After ASCT and During Maintenance1
Response
Cohort 1
Tec-Len (QW to Q4W)
(n=32)
Cohort 2
Tec-Len (Q4W)
(n=32)
Cohort 3
Tec (Q4W)
(n=30)
Response
after ASCTa
Best response
on maintenance
Response
after ASCTa
Best response
on maintenance
Response
after ASCTa
Best response
on maintenance
sCR
31.3
93.8
12.5
75
10
76.7
CR
15.6
6.3
28.1
21.9
50
20
VGPR
34.4
-
43.8
3.1
23.3
3.3
PR
18.8
-
15.6
-
16.7
-
≥CR
46.9
100
40.6
96.9
60
96.7
Abbreviations: ASCT, autologous stem cell transplantation; CR, complete response; EMN, Stichting European Myeloma Network; PR, partial response; Q4W, every 4 weeks; QW, weekly; sCR, stringent complete response; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide; VGPR, very good partial response.
Note: Median follow-up: cohort 1, 35.3 months; cohort 2, 23.7 months; cohort 3, 23.7 months. Efficacy data cutoff date: December 8, 2025.
aAfter ASCT ± consolidation.

MajesTEC-4/EMN30 Study (SRI): MRD-Negativity (10-5) CR rate by NGF in Evaluable Patients After ASCT and During Maintenance1
Cohort 1
Tec-Len (QW to Q4W)
Cohort 2
Tec-Len (Q4W)
Cohort 3
Tec (Q4W)
After ASCTb
(n=21)
At 12 monthsc
(n=19)
After ASCTb
(n=24)
At 12 monthsc
(n=23)
After ASCTb
(n=25)
At 12 monthsc
(n=20)
MRD-negativity CR ratea, %
33.3
100
33.3
100
44
90
Abbreviations: ASCT, autologous stem cell transplantation; EMN, Stichting European Myeloma Network; MRD, minimal residual disease; NGF, next-generation flow cytometry; PD, progressive disease; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide.
Note: Median follow-up: cohort 1, 35.3 months; cohort 2, 23.7 months; cohort 3, 23.7 months. Efficacy data cutoff date: December 8, 2025.aMRD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10-5) by NGF and ≥CR by investigator. MRD negativity must occur within 3 months before or any time after ≥CR, and prior to PD or start of subsequent therapy. For post-ASCT, evaluable patients: ≥1 MRD sample with sufficient cells for evaluation at the testing threshold that resulted in positive or negative on or prior to maintenance start. For 12 months post-maintenance, evaluable patients: (a) ≥1 MRD sample with sufficient cells for evaluation that resulted in positive or negative between 9 and 15 months and prior to PD or start of subsequent therapy; or (b) PD prior to 9 months, or (c) MRD sample that resulted in negative before 9 months and after 15 months, with no MRD positive in between prior to PD or start of subsequent therapy.
bAfter ASCT ± consolidation.
c12 months (+/- 3 months) post-maintenance.

Safety

  • Summary of safety events is shown in Tables: MajesTEC-4/EMN30 Study (SRI): Hematologic AEs and MajesTEC-4/EMN30 Study (SRI): Nonhematologic AEs.
  • The median relative dose intensity ranged from 96% to 99% for TECAVYLI and 55% to 56% for lenalidomide.
  • The treatment discontinuation rate due to treatment-emergent adverse event (TEAEs) was 12.5% in cohort 1 and cohort 2, and 3.3% in cohort 3.
  • No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.
Cytokine Release Syndrome
  • All CRS events were grade 1/2, occurring in 38.3% and 6.4% of patients, respectively.
  • Most CRS events were observed following step-up dosing (SUD) 1 or SUD 2, occurring in 37.2% and 8.5% of patients, respectively.
  • A total of 11.7% of patients received tocilizumab for CRS treatment.
  • All CRS events resolved, no treatment discontinuations were reported.
Infections and Hypogammaglobulinemia
  • Details on infections are provided in Table: MajesTEC-4/EMN30 Study (SRI): Infections for details.
  • One patient in SRI cohort 2 experienced grade 5 coronavirus disease 2019 (COVID-19)-related TEAE.
  • Hypogammaglobulinemia (including patients with ≥1 TEAE of hypogammaglobulinemia or postbaseline immunoglobulin G [IgG] <400 mg/dL) was reported in 96.9% of patients (n=31) in cohort 1, 87.5% of patients (n=28) in cohort 2, and 93.3% of patients (n=28) in cohort 3.
    • Immunoglobulin replacement therapy and antimicrobial prophylaxis were strongly recommended in patients with ≥1 TEAE of hypogammaglobulinemia or postbaseline IgG value <400 mg/dL.
    • Prophylactic intravenous immunoglobulin (IVIG) replacement was advised to maintain serum IgG levels of ≥400 mg/dL.
    • Prophylaxis for Pneumocystis carinii/Pneumocystis jirovecii pneumonia and herpes zoster reactivation and routine antibiotic and antiviral prophylaxis were recommended.

MajesTEC-4/EMN30 Study (SRI): Hematologic AEs1
Hematologic AEsa, n (%)
Cohort 1
Tec-Len (QW to Q4W)
(n=32)
Cohort 2
Tec-Len (Q4W)
(n=32)
Cohort 3
Tec (Q4W)
(n=30)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Neutropenia
30 (93.8)
30 (93.8)
25 (78.1)
25 (78.1)
22 (73.3)
19 (63.3)
Leukopenia
8 (25)
3 (9.4)
0
0
2 (6.7)
1 (3.3)
Lymphopenia
2 (6.3)
1 (3.1)
4 (12.5)
4 (12.5)
6 (20)
4 (13.3)
Febrile neutropenia
3 (9.4)
3 (9.4)
3 (9.4)
3 (9.4)
0
0
Anemia
3 (9.4)
0
2 (6.3)
1 (3.1)
3 (10)
0
Thrombocytopenia
6 (18.8)
2 (6.3)
1 (3.1)
1 (3.1)
2 (6.7)
0
Eosinophilia
1 (3.1)
1 (3.1)
1 (3.1)
1 (3.1)
0
0
Abbreviations: AE, adverse event; EMN, Stichting European Myeloma Network; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide.
Note: Safety data cutoff date: September 17, 2025.
aAEs (graded per NCI-CTCAE Version 5.0); any grade in >25% of patients or grade 3/4 in >1 patient.

MajesTEC-4/EMN30 Study (SRI): Nonhematologic AEs1
Nonhematologic AEsa,b, n (%)
Cohort 1
Tec-Len (QW to Q4W)
(N=32)
Cohort 2
Tec-Len (Q4W)
(N=32)
Cohort 3
Tec (Q4W)
(N=30)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any Grade
Grade 3/4
CRS
16 (50)
0
13 (40.6)
0
13 (43.3)
0
URTI
22 (68.8)
1 (3.1)
13 (40.6)
0
12 (40)
0
Cough
14 (43.8)
0
8 (25)
0
10 (33.3)
0
COVID-19
13 (40.6)
1 (3.1)
7 (21.9)
0
9 (30)
1 (3.3)
Fatigue
10 (31.3)
1 (3.1)
9 (28.1)
1 (3.1)
6 (20)
0
Diarrhea
17 (53.1)
3 (9.4)
12 (37.5)
1 (3.1)
8 (26.7)
0
Pneumonia
8 (25)
4 (12.5)
3 (9.4)
0
2 (6.7)
1 (3.3)
Injection site erythema
7 (21.9)
0
12 (37.5)
0
9 (30)
0
PSN
5 (15.6)
0
9 (28.1)
0
2 (6.7)
0
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; COVID-19, coronavirus disease 2019; EMN, Stichting European Myeloma Network; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; PSN, peripheral sensory neuropathy; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; TEAE, treatment-emergent adverse event; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide; URTI, upper respiratory tract infection.
Note: Safety data cutoff date: September 17, 2025.
aAEs (graded per NCI-CTCAE Version 5.0); any grade in >25% of patients or grade 3/4 in >10% of patients.
bHypogammaglobulinemia based on TEAE reporting also met the ≥25% threshold and is reported separately.

MajesTEC-4/EMN30 Study (SRI): Infections1
Infectionsa, n (%)
Cohort 1
Tec-Len (QW to Q4W)
(n=32)
Cohort 2
Tec-Len (Q4W)
(n=32)
Cohort 3
Tec (Q4W)
(n=30)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any infection
31 (96.9)
12 (37.5)
28 (87.5)
11 (34.4)
27 (90)
8 (26.7)
Most common infectionsb,c
   URTI
22 (68.8)
1 (3.1)
13 (40.6)
0
12 (40)
0
   COVID-19
13 (40.6)
1 (3.1)
7 (21.9)
0
9 (30)
1 (3.3)
   Nasopharyngitis
6 (18.8)
0
4 (12.5)
0
3 (10)
0
   Bronchitis
5 (15.6)
0
1 (3.1)
0
4 (13.3)
1 (3.3)
   Influenza
7 (21.9)
0
2 (6.3)
0
3 (10)
0
   Pneumonia
8 (25)
4 (12.5)
3 (9.4)
0
2 (6.7)
1 (3.3)
   Rhinovirus infection
3 (9.4)
0
4 (12.5)
0
0
0
Abbreviations: COVID-19, coronavirus disease 2019; EMN, Stichting European Myeloma Network; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide; URTI, upper respiratory tract infection.
Note: Safety data cutoff date: September 17, 2025.
aAEs (graded per NCI-CTCAE Version 5.0).
bAny grade in >10% of patients
cOccurring in >10% of patients with any grade AEs in any arm.

Zamagni et al (2024)2 presented the preliminary efficacy and safety results from the SRI of cohort 1 at a median follow-up of 21.1 months (range, 14.8-23.8), cohort 2 at a median follow-up of 9.2 months (range, 1.2-12.2), and cohort 3 at a median follow-up of 9.2 months (range, 3.7- 11.5).

Results

Treatment Disposition


MajesTEC-4/EMN30 Study (SRI Cohorts): Treatment Disposition and Exposure2
Parameter, n
Cohort 1
Tec-Len (QW to Q4W)
(N=32)
Cohort 2
Tec-Len (Q4W)
(N=32)
Cohort 3
Tec (Q4W)
(N=30)
Treatment discontinuation
7
1
4
   AEs
3
1
1
   Patient withdrawal
2
-
1
   Physician decision
1
-
-
   Progressive disease
1
-
1
   Othera
-
-
1
Ongoing treatment
25
31
26
Abbreviations: AE, adverse event; EMN, Stichting European Myeloma Network; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide.
Note: Median follow-up time: cohort 1, 21.1 months (range, 14.8-23.8); cohort 2, 9.2 months (range, 1.2 [censored observation]-12.2), cohort 3, 9.2 months (range, 3.7-11.5). Clinical data cutoff date: September 9, 2024.
aPatient decision.

Efficacy


MajesTEC-4/EMN30 Study (SRI Cohorts): Response Rates After ASCT and During Maintenance2
Response, %
Cohort 1
Tec-Len (QW to Q4W)
(N=32)
Cohort 2
Tec-Len (Q4W)
(N=32)
Cohort 3
Tec (Q4W)
(N=30)
Response
after ASCTa
Best response
on maintenance
Response
after ASCTa
Best response
on maintenance
Response
after ASCTa
Best response
on maintenance
sCR
18.8
90.6
12.5
65.6
3.3
70.0
CR
18.8
9.4
12.5
25.0
30.0
23.3
VGPR
40.6
-
56.3
9.4
43.3
6.7
PR
21.9
-
18.8
-
23.3
-
≥CR
37.6
100.0
25.0
90.6
33.3
93.3
Abbreviations: ASCT, autologous stem cell transplantation; CR, complete response; EMN, Stichting European Myeloma Network; PR, partial response; Q4W, every 4 weeks; QW, weekly; sCR, stringent complete response; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide; VGPR, very good partial response.
Note: Median follow-up: cohort 1, 21.1 months (range, 14.8-23.8); cohort 2, 9.2 months (range, 1.2 [censored observation]-12.2), cohort 3, 9.2 months (range, 3.7-11.5). Clinical data cutoff date: September 9, 2024.
aAfter ASCT ± consolidation.

MajesTEC-4/EMN30 Study (SRI Cohorts): MRD Negativity (10-5) in Evaluable Patients After ASCT and During Maintenance2
Cohort 1
Tec-Len (QW to Q4W)
(N=32)
Cohort 2
Tec-Len (Q4W)
(N=32)
Cohort 3
Tec (Q4W)
(N=30)
After ASCTb
(n=27)
At 12 months
(n=28)
After ASCTb
(n=30)
At 6 months
(n=26)
After ASCTb
(n=30)
At 6 months
(n=22)
MRD-negativity ratea, %
63.0
100.0
83.3
100.0
73.3
100.0
Abbreviations: ASCT, autologous stem cell transplantation; EMN, Stichting European Myeloma Network; MRD, minimal residual disease; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide.
Note: Median follow-up: cohort 1, 21.1 months (range, 14.8-23.8); cohort 2, 9.2 months (range, 1.2 [censored observation]-12.2), cohort 3, 9.2 months (range, 3.7-11.5). Clinical data cutoff date: September 9, 2024.aMRD-negativity rate was defined as the proportion of patients who achieved MRD negativity (10-5) regardless of response. The denominator for percentages is the number of evaluable patients. Among 87 evaluable patients, 23 patients were MRD positive at screening (cohort 1, n=10; cohort 2, n=5; cohort 3, n=8). All patients who were MRD positive at study entry and had an assessment during treatment were MRD negative during treatment. One patient in cohort 1 was MRD positive at 18 months.
bAfter ASCT ± consolidation.

Safety

  • TEAEs of any grade were reported in 100% of patients in all cohorts. Grade 3/4 TEAEs were reported in 100% of patients (n=32) in cohort 1, 84.4% of patients (n=27) in cohort 2, and in 56.7% of patients (n=17) in cohort 3. Additional details are provided in Tables: MajesTEC-4/EMN30 Study (SRI Cohorts): Hematologic AEs and MajesTEC-4/EMN30 Study (SRI Cohorts): Nonhematologic AEs.
  • Median relative dose intensity ranged from 95.5% to 99.7% for TECAVYLI and 58.4% to 61.5% for lenalidomide.
  • Overall treatment discontinuation rate was 5.3% due to TEAEs.
  • Cumulative incidence of grade 3/4 neutropenia at 6 months were 81.3% for cohort 1, 56.3% for cohort 2, and 40.0% for cohort 3, respectively.
  • No ICANS was reported.
Cytokine Release Syndrome
  • Cytokine release syndrome (CRS) was reported in 50.0% of patients (n=16) in cohort 1, 40.6% of patients (n=13) in cohort 2, and in 43.3% of patients (n=12) in cohort 3. All events were grade 1/2. The incidence of CRS was 37.2% after SUD 1, 8.5% after SUD 2 and 5.3% after treatment dose 1.
  • No discontinuations were reported due to CRS.
Infections and Hypogammaglobulinemia
  • Details on infections are provided in Table: MajesTEC-4/EMN30 Study (SRI Cohorts): Infections for details. One death due to coronavirus disease 2019 (COVID-19)-related TEAE was reported in SRI cohort 2.
  • Hypogammaglobulinemia (including patients with ≥1 TEAE of hypogammaglobulinemia or postbaseline IgG <400 mg/dL) was reported in 96.9% of patients (n=31) in cohort 1, 78.1% of patients (n=25) in cohort 2, and 93.3% of patients (n=28) in cohort 3. All patients received ≥1 dose of IVIG or subcutaneous immunoglobulin (SCIg).
  • Prophylactic IVIG replacement was advised to maintain serum IgG levels of ≥400 mg/dL. Prophylaxis for Pneumocystis carinii/Pneumocystis jirovecii pneumonia and herpes zoster reactivation and routine antibiotic and antiviral prophylaxis were recommended.

MajesTEC-4/EMN30 Study (SRI Cohorts): Hematologic AEs2
Hematologic AEsa, n (%)
Cohort 1
Tec-Len (QW to Q4W)
(N=32)
Cohort 2
Tec-Len (Q4W)
(N=32)
Cohort 3
Tec (Q4W)
(N=30)
Any Grade
Grade ¾
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Neutropenia
30 (93.8)
30 (93.8)
21 (65.6)
20 (62.5)
17 (56.7)
14 (46.7)
Leukopenia
9 (28.1)
3 (9.4)
1 (3.1)
0
1 (3.3)
1 (3.3)
Lymphopenia
2 (6.3)
1 (3.1)
4 (12.5)
4 (12.5)
4 (13.3)
4 (13.3)
Febrile neutropenia
3 (9.4)
3 (9.4)
3 (9.4)
3 (9.4)
0
0
Anemia
3 (9.4)
0
1 (3.1)
1 (3.1)
1 (3.3)
0
Thrombocytopenia
6 (18.8)
2 (6.2)
0
0
2 (6.7)
0
Eosinophilia
1 (3.1)
1 (3.1)
1 (3.1)
1 (3.1)
0
0
Abbreviations: AE, adverse event; EMN, Stichting European Myeloma Network; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide.
Note: Clinical data cutoff date: September 9, 2024.
aAEs (graded according to the NCI-CTCAE version 5.0) occurring in >25% of patients with any grade AEs or >1 patient with grade 3/4 AEs in any arm.

MajesTEC-4/EMN30 Study (SRI Cohorts): Nonhematologic AEs2
Nonhematologic AEsa,b, n (%)
Cohort 1
Tec-Len (QW to Q4W)
(N=32)
Cohort 2
Tec-Len (Q4W)
(N=32)
Cohort 3
Tec (Q4W)
(N=30)
Any Grade
Grade ¾
Any Grade
Grade 3/4
Any Grade
Grade 3/4
CRS
16 (50.0)
0
13 (40.6)
0
13 (43.3)
0
URTI
20 (62.5)
1 (3.1)
13 (40.6)
0
8 (26.7)
0
Cough
15 (46.9)
0
6 (18.8)
0
8 (26.7)
0
COVID-19
12 (37.5)
1 (3.1)
5 (15.6)
0
9 (30.0)
1 (3.3)
Fatigue
10 (31.3)
1 (3.1)
8 (25.0)
1 (3.1)
5 (16.7)
0
Diarrhea
13 (40.6)
3 (9.4)
9 (28.1)
1 (3.1)
6 (20.0)
0
Pneumonia
9 (28.1)
4 (12.5)
3 (9.4)
0
2 (6.7)
1 (1.3)
Injection site erythema
7 (21.9)
0
12 (37.5)
0
8 (26.7)
0
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; COVID-19, coronavirus disease 2019; EMN, Stichting European Myeloma Network; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; TEAE, treatment-emergent adverse event; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide; URTI, upper respiratory tract infection.
Note: Clinical data cutoff date: September 9, 2024.
aAEs (graded according to the NCI-CTCAE version 5.0) occurring in >25% of patients with any grade AEs or >1 patient with grade 3/4 AEs in any arm.
bHypogammaglobulinemia based on TEAE reporting also met the ≥25% threshold and is reported separately.

MajesTEC-4/EMN30 Study (SRI Cohorts): Infections2
Infectionsa,b, n (%)
Cohort 1
Tec-Len (QW to Q4W)
(N=32)
Cohort 2
Tec-Len (Q4W)
(N=32)
Cohort 3
Tec (Q4W)
(N=30)
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any Grade
Grade 3/4
Any infection
30 (93.8)
12 (37.5)
25 (78.1)
9 (28.1)
23 (76.7)
6 (20.0)
Most common infectionsc
URTI
20 (62.5)
1 (3.1)
13 (40.6)
0
8 (26.7)
0
COVID-19
12 (37.5)
1 (3.1)
5 (15.6)
0
9 (30.0)
1 (3.3)
Pneumonia
9 (28.1)
4 (12.5)
3 (9.4)
0
2 (6.7)
1 (3.3)
Nasopharyngitis
6 (18.8)
0
0
0
3 (10.0)
0
Abbreviations: COVID-19, coronavirus disease 2019; EMN, Stichting European Myeloma Network; IgG, immunoglobulin; IVIG, intravenous immunoglobulin; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; PCP, Pneumocystis carinii pneumonia; PJP, Pneumocystis jirovecii pneumonia; Q4W, every 4 weeks; QW, weekly; SRI, safety run-in; Tec, TECVAYLI; Tec-Len, TECVAYLI + lenalidomide; URTI, upper respiratory tract infection.
Note: Clinical data cutoff date: September 9, 2024.
aAdverse events (graded according to the NCI-CTCAE version 5.0).
bProphylactic IVIG replacement advised to maintain serum IgG levels of ≥400 mg/dL. Prophylaxis for PCP/PJP and herpes zoster reactivation and routine antibiotic and antiviral prophylaxis were recommended.
cOccurring in >10% of patients with any grade AEs in any arm.

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 02 July 2026.

 

References

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1 van de donk N, Silzle T, Špička I, et al. Teclistamab +/-lenalidomide versus lenalidomide alone as maintenance therapy post-transplant in newly diagnosed multiple myeloma: updated safety run-in results from EMN30/MajesTEC-4. Oral presentation presented at: 31st European Hematology Association (EHA) Annual Meeting; June 11-14, 2026; Stockholm, Sweden.  
2 Zamagni E, Silzle T, Špička I, et al. Phase 3 study of teclistamab with lenalidomide, teclistamab alone, and lenalidomide alone as maintenance therapy in newly diagnosed multiple myeloma post-autologous stem cell transplant: safety run-in results from the EMN30/MajesTEC-4 trial. Oral Presentation presented at: The 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024; San Diego, CA.  
3 Zamagni E, Boccadoro M, Spencer A, et al. MajesTEC-4 (EMN30): a phase 3 trial of teclistamab + lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy following autologous stem cell transplantation in patients with newly diagnosed multiple myeloma. presented at: 64th American Society of Hematology (ASH) Annual Meeting & Exposition; December 10-13, 2022; New Orleans, LA/Virtual meeting.  

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