Journal Article

DKFZ-2026-01554

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Teclistamab-based induction treatment in transplant-eligible, newly diagnosed multiple myeloma: a phase 2 trial.

Raab, M. S. ; Weinhold, N. ; Kortüm, K. M. ; Krönke, J.DKFZ* ; Fenk, R. ; Weisel, K. ; Podola, L. ; Bertsch, U. ; Brobeil, A. ; Mersi, J. ; Huhn, S. ; Arlinghaus, R. ; Hundemer, M. ; Bohl, S. R. ; Mai, E. K. ; Schub, N. ; Waldschmidt, J. ; Bassermann, F.DKFZ* ; Müller-Tidow, C. ; Heuck, C. ; Sakabedoyan, C. ; Khan, J. ; Ershova, E. ; Koster, B. D. ; Engelhardt, M. ; Hänel, M. ; Salwender, H. ; Teipel, R. ; Goldschmidt, H. ; Einsele, H. ; Rasche, L. ; GMMG-HD10/DSMM-XX (Collaboration Author) ; Kortüm, K. M. (Contributor)

2026
Springer Nature [New York, NY]

Abstract: Advancements in frontline therapies have substantially improved outcomes in newly diagnosed multiple myeloma (NDMM); however, many patients will not achieve deep responses and will relapse. Teclistamab, a BCMA×CD3 bispecific antibody, in combination with daratumumab, has demonstrated strong efficacy in relapsed/refractory multiple myeloma versus standard of care as early as first relapse. This ongoing phase 2 GMMG-HD10/DSMM-XX (MajesTEC-5) study evaluates teclistamab-based regimens in transplant-eligible NDMM. In this prespecified pooled analysis of three cohorts, 49 patients received teclistamab/daratumumab/lenalidomide (Tec-DR; arms A and A1) or Tec-DR with bortezomib (Tec-DVR; arm B). Primary endpoints were incidence and severity of adverse events (AEs) and serious AEs; secondary endpoints included overall response rate (ORR), minimal residual disease (MRD) negativity and MRD-negative complete response (CR). The current analysis spans the induction and autologous stem cell transplantation phases until the premaintenance timepoint. Grade 3 or 4 treatment-emergent AEs (TEAEs) occurred in 91.8% (45/49); most were hematologic (lymphopenia (59.2%; 29/49), neutropenia (59.2%; 29/49) and leukopenia (18.4%; 9/49)). No grade 5 TEAEs were reported. Serious AEs occurred in 55.1% (27/49); pyrexia (12.2% (6/49)) was most common. Any-grade and grade 3 or 4 infections occurred in 81.6% (40/49) and 36.7% (18/49), respectively, the most common grade 3 or 4 infections being COVID-19 and pneumonia (6.1% (3/49) each). Cytokine release syndrome occurred in 67.3% (33/49); all were grade 1 or 2, all resolved and none led to discontinuation of any study treatment. No treatment-related immune effector cell-associated neurotoxicity syndrome (ICANS) events occurred. Across arms, the MRD-negative CR rate was 91.8% (45/49) by the premaintenance timepoint; the MRD negativity rate was 100% in evaluable samples at postinduction cycle 3 (1 × 10-5 (46/46)), cycle 6 (1 × 10-5 (46/46) and 1 × 10-6 (46/46)) and premaintenance (1 × 10-5 (40/40)); the ORR was 100% (49/49). Total median stem cell yield was 8.1 × 106 per kg. Data support the feasibility of Tec-D(V)R induction in transplant-eligible NDMM, with a consistent safety profile compared with individual regimen components and notable early MRD negativity rates. ClinicalTrials.gov identifier: NCT05695508 .

Note: epub

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Contributing Institute(s):

1. DKTK Koordinierungsstelle Berlin (BE01)
2. DKTK Koordinierungsstelle München (MU01)

Research Program(s):

1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2026

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; DEAL Nature ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 80 ; JCR ; Nationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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