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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TECVAYLI® (teclistamab-cqyv)

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TECVAYLI - MajesTEC-9 (MMY3006) Study

Last Updated: 03/19/2025

SUMMARY

Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
MajesTEC-9 (MMY3006) is an ongoing, phase 3, randomized, open-label, multicenter study comparing TECVAYLI with investigator’s choice of pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM) who previously received 1-3 prior lines of therapy (LOTs) including an anti-CD38 monoclonal antibody and lenalidomide. The study is currently ongoing, and results have not been published.¹^,²

CLINICAL DATA - MajeSTEC-9 Study

MajesTEC-9 (MMY3006; clinicaltrials.gov identifier NCT05572515) is an ongoing, phase 3, randomized, open-label, multicenter study comparing TECVAYLI with investigator’s choice of PVd or Kd in patients with RRMM who previously received 1-3 prior LOTs including an anti-CD38 monoclonal antibody and lenalidomide.¹^,²

Study Design/Methods

The study design is presented in the Figure: MajesTEC-9 Study Design.¹^,²

MajesTEC-9 Study Design¹^,²

Abbreviations: ADA, anti-drug antibody; AE, adverse event; BCMA, B-cell maturation antigen; CR, complete response; CRS, cytokine release syndrome; ECOG PS, Eastern Cooperative Oncology Group performance status; EOT, end of treatment; HRQoL, health-related quality of life; IMWG, International Myeloma Working Group; Kd, carfilzomib and dexamethasone; LOT, line of therapy; mAb, monoclonal antibody; MM, multiple myeloma; OS, overall survival; PD, pharmacodynamics; PFS2, progression-free survival on next-line therapy; PFS, progression-free survival; PK, pharmacokinetics; PR, partial response; PRO, patient-reported outcome; PVd, pomalidomide, bortezomib and dexamethasone; R, randomization; RRMM, relapsed or refractory multiple myeloma; SAE, serious adverse events; TTNT, time to next treatment; VGPR, very good partial response.
^aRandomization will be stratified by choice of PVd or Kd, stage of disease, anti-CD38 mAb-refractory status, and the number of prior LOTs.
^bInvestigator’s choice of PVd or Kd.

LITERATURE SEARCH

A literature search of Ovid MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 14 March 2025.

References

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Janssen Research & Development, LLC. A phase 3 randomized study comparing teclistamab monotherapy versus pomalidomide, bortezomib, dexamethasone (PVd) or carfilzomib, dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 March 14]. Available from: https://clinicaltrials.gov/ct2/show/NCT05572515 NLM Identifier: NCT05572515.

Touzeau C, Hungria V, Bhutani D, et al. MajesTEC-9: a randomized phase 3 study of teclistamab versus pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Poster presented at: The 2023 American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL & Virtual.