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December 8, 2025Blood

A phase 2 trial of teclistamab plus daratumumab combination therapy for high-risk smoldering multiple myeloma: First pre-planned analysis (the REVIVE Study)

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Authors

OLOla LandgrenAPAbhishek PandeyJHJames E. Hoffman

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Overview

Phase II trial shows 100% overall response in high-risk smoldering multiple myeloma, indicating effective treatment and safety.

Key Points

  • To evaluate the efficacy and safety of a combination therapy of teclistamab and daratumumab in high-risk smoldering multiple myeloma.
  • Single-center, phase II study of teclistamab plus daratumumab
  • Participants: high-risk smoldering multiple myeloma patients
  • Primary endpoint: rate of minimal residual disease (MRD)-negativity after 12 cycles of treatment
  • Evaluated safety, tolerability, and overall response rate
  • Utilized NCI-PROMIS for quality of life metrics.
  • 15 patients enrolled with a median age of 57 years
  • Overall response rate was 100% with 11 of 13 evaluable patients achieving stringent complete response
  • 85% attained 10-5 MRD-negativity
  • No progressions to active multiple myeloma or deaths reported
  • 5 drug-related adverse events, but no serious AEs observed.

Cite This Study

Landgren et al. (2025) studied this question.

synapsesocial.com/papers/69362f714fa91c937236e174https://doi.org/10.1182/blood-2025-5775
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