MajesTEC-5 (NCT05695508) is a Phase 2 trial testing the BCMA-directed bispecific antibody teclistamab (Tecvayli) added to daratumumab-lenalidomide (DR), with or without bortezomib, as induction therapy in transplant-eligible newly diagnosed multiple myeloma. Early multi-cohort data (ASH 2024) show very high response rates and near-universal (approaching 100%) MRD-negativity; overall survival is immature. This frontline induction use is investigational. Sponsor: Janssen / Johnson & Johnson with German myeloma groups.
Discover KOL Sentiment on MajesTEC-5 →Design — Phase 2 multi-cohort (MMY2003 / GMMG-HD10 / DSMM-XX); teclistamab (Tecvayli) + daratumumab-lenalidomide (DR) +/- bortezomib as induction, transplant-eligible newly diagnosed multiple myeloma (NCT05695508). Janssen with GMMG/DSMM. (ASH 2024)
Response / MRD (induction) — Very high response with near-universal MRD-negativity in early cohorts: Arm A (Tec-DR weekly, n=10) ORR 100%, 100% MRD-negative; Arm A1 (Tec-DR Q4W, n=20) ORR 90-100%, 100% MRD-negative; Arm B (Tec-DVR with bortezomib, n=19) ORR 89.5-100%, 100% MRD-negative. (ASH 2024)
Overall survival — Immature — the primary analysis includes post-induction/ASCT and maintenance phases (ongoing). (ASH 2024)
Safety — Key adverse events: infections (requiring stringent prophylaxis), peripheral neuropathy (Grade >=2 ~16% with weekly bortezomib), and low-grade cytokine release syndrome; weekly bortezomib scheduling reduced neuropathy versus twice-weekly. (ASH 2024)
Positioning — Potential new induction standard; direct frontline competitor to CAR-T strategies such as CARTITUDE-6 (cilta-cel) in transplant-eligible NDMM. Phase 3 confirmation pending. (KOL commentary)
Regulatory / Sponsor — INVESTIGATIONAL — frontline teclistamab induction is not FDA approved; Tecvayli is approved only for relapsed/refractory MM after >=4 prior lines. Janssen / J&J with GMMG and DSMM. (FDA label)
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.
Top tweets by impressions — click to view on X
#IMS25 In my mind, this will be the slayer of ASCT more than any other #MMsm regimen...
Excellent Tec-DVR & Tec-DR data [1x weekly Velcade & lots of IVIG 👏] in NDMM from MajesTEC-5 @RaabMarc…
Why is everyone so excited about this? #ASH24 https://t.co/HFHaxODnxg
‼️100% MRD Negativity after 6 cycles of Teclistamab-based induction in NDMM is something we will remember @RaabMarc #myeloma #IMS2025 https://t.co/0PU0a1tjmg
Updates from MajesTEC-5:
Continue to see unprecedented mrd negativity rates after just 6 cycles of teclistamab + Dara-R and +\- bortezomib.
Pretty clear that bortezomib thus far not offering benefit.…
Exciting data from MajesTEC-5 by Dr. Raab. Tec-Dara based induction leading to ~100% MRD-negativity rate by NGS at 10^-6 post Cycle#6. At ~7 mo f/u risk of Grade 3 or higher infection ~37% (no deaths…
#IMS25 MajesTEC_5: Tec+DaraRV for TE NDMM:
N=50, 100% MRD neg by NGS 10-6 after C6, all pts collected stem cells
G3 infection 33%, hypogamma 90%
MRD neg much higher than SOC DRVd
Id this Rx for…
MjesTEC-5 ORR 100%, 95-100 CR, MRD- 100% including 10-6.
#IMS2025 #mmsm https://t.co/IuQ8LHZJNj
#BeyondBlood in Mexico City - @RobertoMinaMD giving an excellent talk about transplant-eligible myeloma in 2025.
First time with these evergreen #MMsm talks that BCMA is now being added in after…
$JNJ's shot at 1st-line multiple myeloma: Tecvayli in Majestec-5 study in transplant-eligible patients. Note Pomalyst + Revlimid (+Velcade) combo and uncontrolled study #ASH24 https://t.co/u4Kwk3vH8e
@Rfonsi1 Is this a year 2000, STI571 moment?
MajesTEC-5 positions teclistamab + DR ± bortezomib as a potential new induction regimen in TE-NDMM with unprecedented MRD negativity rates. Phase 3 confirmation pending. Direct competitor: CARTITUDE-6 (cilta-cel front-line) for the TE-NDMM landscape.
Arm A (Tec-DR weekly, n=10): ORR 100%, sCR/≥CR 100%, 100% MRD-negative by NGS. Arm A1 (Tec-DR Q4W, n=20): ORR 90-100%, ≥CR 95%, 100% MRD-neg. Arm B (Tec-DVR Q4W with bortezomib, n=19): ORR 89.5-100%, ≥CR 73.7%, 100% MRD-neg. Unprecedented depth of response during induction alone.
OS data immature; primary analysis includes post-induction/ASCT + maintenance phases (ongoing).
Key AEs: infections (require stringent prophylaxis), peripheral neuropathy (G≥2: 16% with weekly bortezomib), CRS (low-grade). Weekly bortezomib scheduling reduces peripheral neuropathy vs. twice-weekly. Tolerable in early NDMM cohorts with maturing data. Infection prophylaxis critical given bispecific activity.
⚠️ Phase 2 signal — potential new induction standard. MajesTEC-5 positions teclistamab + DR ± bortezomib as a potential new induction regimen in TE-NDMM with unprecedented MRD negativity rates. Phase 3 confirmation pending. Direct competitor: CARTITUDE-6 (cilta-cel front-line) for the TE-NDMM landscape.
MajesTEC-5 (NCT05695508; also MMY2003 / GMMG-HD10 / DSMM-XX) is a Phase 2, multi-cohort trial evaluating the BCMA-directed bispecific antibody teclistamab (Tecvayli) combined with daratumumab plus lenalidomide (DR), with or without bortezomib, as induction therapy in transplant-eligible newly diagnosed multiple myeloma. It is run by Janssen / Johnson & Johnson with the German myeloma groups GMMG and DSMM.
Early induction-phase results at ASH 2024 showed very high response rates (about 89.5-100%) and near-universal MRD-negativity approaching 100% by next-generation sequencing across small cohorts — for example 100% ORR and 100% MRD-negativity in the weekly teclistamab-DR arm. Overall survival is immature because the primary analysis spans induction, transplant and maintenance.
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 induction in newly diagnosed, transplant-eligible myeloma in MajesTEC-5 is investigational and not FDA approved.
MajesTEC-5 tests whether adding a highly active BCMA bispecific antibody to a modern daratumumab-based induction backbone can drive unprecedented depth of response — near-universal MRD-negativity — before transplant. If confirmed in Phase 3, it could reshape frontline induction and is often discussed alongside frontline CAR-T strategies such as CARTITUDE-6.
Key risks include serious infections (managed with stringent prophylaxis and consistent with teclistamab's known infection risk), peripheral neuropathy from bortezomib (Grade 2 or higher in about 16% with weekly dosing), and low-grade cytokine release syndrome. Weekly rather than twice-weekly bortezomib scheduling reduced peripheral neuropathy in the early cohorts.