MAJESTEC-4 (EMN30) is a Phase 3 trial testing the BCMA-directed bispecific antibody teclistamab (Tecvayli), alone or with lenalidomide, versus lenalidomide alone as maintenance therapy after autologous stem-cell transplant in newly diagnosed multiple myeloma. Teclistamab is FDA-approved only for relapsed/refractory myeloma; this frontline post-transplant maintenance use is investigational. A safety run-in was presented at ASH 2024 and updated at EHA 2026. Sponsor: Janssen / Johnson & Johnson with the European Myeloma Network.
Discover KOL Sentiment on MAJESTEC-4 →Design — Phase 3 randomized (EMN30); teclistamab (Tecvayli) alone or + lenalidomide vs lenalidomide alone as maintenance after autologous stem-cell transplant, newly diagnosed multiple myeloma (NCT05243797). (ASH 2024 safety run-in)
Status of data — Safety run-in only — presented ASH 2024 (Zamagni et al.), updated EHA 2026 (van de Donk); randomized efficacy (PFS/MRD/OS) readout pending. (ASH 2024 / EHA 2026)
Rationale — Tests whether adding a BCMA bispecific to standard lenalidomide maintenance deepens/sustains responses post-transplant; direct conceptual competitor to frontline CAR-T maintenance strategies. (trial design)
Safety focus — Teclistamab class effects under evaluation in the maintenance setting: cytokine release syndrome, infections (including hypogammaglobulinemia-related) and neurotoxicity per the Tecvayli REMS. (ASH 2024)
Regulatory — INVESTIGATIONAL — frontline post-transplant teclistamab maintenance is not FDA approved; Tecvayli is approved only for relapsed/refractory MM after >=4 prior lines. (FDA label)
Sponsor / Drug — Janssen / Johnson & Johnson with the European Myeloma Network; teclistamab (Tecvayli), a BCMA x CD3 bispecific antibody. (trial design)
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.
#ASH24 #mmsm 1️⃣0️⃣ Majestec-4/EMN30 Trial ➡️ https://t.co/gAOFjnxR4S ✅Multiple cohorts comparing Tec alone, Tec-Len vs Len alone post ASCT- time limited maintenance in all pts Will be interesting to see if intensifying maintenance for 2 yrs will improve efficacy/safety https://t.co/KclSGJQAU1
#EHA2026 #nielsvandedonk MajesTEC-4 SRI data At first glance, shocking that tec (bsAb) dose intensity so much higher than len dose intensity (~90% vs ~50%) 🤯 But honestly not surprising - len maintenance can be tough! Q4W tec with optimal supportive care quite maintainable. https://t.co/Akl05eWwdP
Dr. Niels van de Donk updating MajesTEC-4 at #EHA26 #EHA2026 #mmsm https://t.co/6cAyjdUNYT
MajesTEC-4: Trial using Tec vs Tec+Len in maintenance post ASCT ! This is early, but the P3 trial of BCMA bispecifics is going to be a huge change in how we manage NDMM. Globally ~180K NDMM are diagnosed, and about ~30-40% are potentially transplant eligible. Having a therapy https://t.co/4DXqTuWtvk
CONGRESS | #EHA2026 | PRESENTATION Niels van de Donk presents updated safety run-in results from the MajesTEC-4 study evaluating teclistamab ± lenalidomide versus lenalidomide alone as post-transplant maintenance for NDMM. Teclistamab-based maintenance was associated with grade https://t.co/ahupBsfwhC
It’s MajesTEC-1,2,3,4,5,7,9… but I call it #MagicTec ✨🧬 An easier way to remember the journey: 🔹 Magic 1 Advanced / heavily pretreated disease 🔹 Magic 3 1st+ relapse, non-Dara refractory (teclistamab + Dara moving earlier) 🔹 Magic 4 Maintenance after transplant https://t.co/PJ61zpl6tn
@RahulBanerjeeMD @DrGPrakash @DrPMPGI I like that Teclistamab was used as maintenance post ASCT for pt#2. With uncontrolled chemo refractory EMD, going straight to ASCT often leads to relapse <60 days post ASCT. For EMD with primary ref disease, I do not think Len, D+Len lead to durable remissions. Good to see there
Very good point - kudos to team for investigating it! I totally agree: once MajesTEC-4 approved, this will probably be the best use case for indefinite bsAb maintenance in #MMsm. And as time-limited bsAb maintenance becomes the norm, we’ll see it for even more subgroups! https://t.co/pwEEq3XfGM
I felt the same - amongst the myeloma abstracts, there were many exciting BsAb studies, and the MajesTEC-4 data, tho preliminary, are incredibly exciting @HadidiSamer https://t.co/V9sojEb9G4
#ASH24 #mmsm 1️⃣0️⃣ Majestec-4/EMN30 Trial ➡️ https://t.co/gAOFjnxR4S ✅Multiple cohorts comparing Tec alone, Tec-Len vs Len alone post ASCT- time limited maintenance in all pts Will be interesting to see if intensifying maintenance for 2 yrs will improve efficacy/safety https://t.co/KclSGJQAU1
Dr. Niels van de Donk updating MajesTEC-4 at #EHA26 #EHA2026 #mmsm https://t.co/6cAyjdUNYT
5- MajesTEC-4, Less is more with teclistamab in low burden settings. https://t.co/lfzuPA2ooY
MajesTEC-4: Trial using Tec vs Tec+Len in maintenance post ASCT ! This is early, but the P3 trial of BCMA bispecifics is going to be a huge change in how we manage NDMM. Globally ~180K NDMM are diagnosed, and about ~30-40% are potentially transplant eligible. Having a therapy https://t.co/4DXqTuWtvk
Ph3 Teclistamab (Tec) + Lenalidomide (R) and Tec Alone vs R Alone in NDMM As Maintenance Tx Following ASCT: Safety Run-in (SRI) Results from the Majestec-4/EMN30 Trial [Dec 8, 2024] Zamagni et al. #ASH24 Abst 494 https://t.co/ex2Nv2jVXc #mmsm #caxtx
CONGRESS | #EHA2026 | PRESENTATION Niels van de Donk presents updated safety run-in results from the MajesTEC-4 study evaluating teclistamab ± lenalidomide versus lenalidomide alone as post-transplant maintenance for NDMM. Teclistamab-based maintenance was associated with grade https://t.co/ahupBsfwhC
MAJESTEC-4 (EMN30; NCT05243797) is the first Phase 3 trial to test a BCMA-directed bispecific antibody as maintenance therapy after autologous stem-cell transplant (ASCT) in newly-diagnosed multiple myeloma. It randomizes transplant-eligible patients to teclistamab + lenalidomide, teclistamab alone, or lenalidomide alone, asking whether adding a T-cell-engaging bispecific to (or in place of) standard lenalidomide maintenance can deepen and sustain MRD-negative remissions. A safety run-in (SRI) was presented at ASH 2024 (Zamagni et al.) and updated at EHA 2026 (van de Donk). Teclistamab is FDA-approved only for relapsed/refractory myeloma; its use as frontline maintenance here is investigational.
Phase 3, randomized, open-label. The safety run-in evaluated three maintenance cohorts after ASCT: Cohort 1 teclistamab QW→Q4W + lenalidomide (n=32); Cohort 2 teclistamab Q4W + lenalidomide (n=32); Cohort 3 teclistamab Q4W alone (n=30). Dual primary endpoints: PFS and 12-month MRD-negative CR (NGF, 10⁻⁵).
Responses deepened on maintenance across all three cohorts. ≥CR reached 100% in Cohort 1 (Tec-Len QW→Q4W), 90.6% in Cohort 2 (Tec-Len Q4W) and 93.3% in Cohort 3 (Tec alone) — driven largely by sCR (90.6% / 65.6% / 70.0%). MRD-negativity (10⁻⁵, NGF) reached 100% of evaluable patients during maintenance in every cohort, up from 63.0% / 83.3% / 73.3% after ASCT. Median PFS was not reached in any cohort. These remain safety-run-in cohorts (≈30 patients each; median follow-up 21.1 months in Cohort 1, ~9.2 months in Cohorts 2–3), not randomized efficacy outcomes.
Grade 3–4 TEAEs occurred in 100% (Cohort 1), 84.4% (Cohort 2) and 56.7% (Cohort 3) — the gradient tracking teclistamab intensity. There were no cases of ICANS and no grade ≥3 CRS; grade 1–2 CRS occurred in 50.0% / 40.6% / 43.3%, and one COVID-19 death occurred in Cohort 2. Median teclistamab relative dose intensity was 95.5–99.7% (lenalidomide 58.4–61.5%), supporting feasibility of schedule-adjusted, teclistamab-based maintenance.
MAJESTEC-4 (also known as EMN30; NCT05243797) is a Phase 3, randomized trial evaluating the BCMA-directed bispecific antibody teclistamab (Tecvayli), given alone or with lenalidomide, versus lenalidomide alone as maintenance therapy after autologous stem-cell transplant in newly diagnosed multiple myeloma. It is run by Janssen / Johnson & Johnson with the European Myeloma Network.
To date only a safety run-in has been reported — presented at ASH 2024 (Zamagni et al.) and updated at EHA 2026 (van de Donk). The randomized efficacy readout (progression-free survival, MRD and overall survival) is still pending, so the trial has not yet delivered practice-changing efficacy results.
No. Teclistamab (Tecvayli) is FDA approved only for relapsed or refractory multiple myeloma after at least four prior lines of therapy (accelerated approval, October 2022). Its use as frontline post-transplant maintenance in MAJESTEC-4 is investigational and not FDA approved.
MAJESTEC-4 tests whether moving a highly active BCMA bispecific antibody into frontline maintenance can deepen and sustain remissions after transplant, potentially reshaping post-transplant maintenance. It is a key part of the broader effort to bring T-cell-redirecting therapies earlier in the myeloma treatment course, alongside frontline CAR-T strategies.
Teclistamab carries class-specific risks — cytokine release syndrome, neurotoxicity, and serious infections related to hypogammaglobulinemia — managed under the Tecvayli REMS program. A dedicated safety run-in in MAJESTEC-4 is characterizing these risks in the newly-diagnosed maintenance setting before the full efficacy analysis.
