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Venetoclax-based treatment combinations in relapsed/refractory multiple myeloma: practice patterns and impact of

Abiola Bolarinwa1, Madhu Nagaraj1, Saurabh Zanwar1

  • 1Division of Hematology, Mayo Clinic, Rochester, MN, USA.

Blood Cancer Journal
|April 4, 2025
PubMed

Insights

Venetoclax shows efficacy in relapsed/refractory multiple myeloma (RRMM) patients with t(11;14). However, its effectiveness is limited in patients lacking this genetic marker, especially with high-risk cytogenetics.

Area of Science:

  • Hematology
  • Oncology
  • Clinical Pharmacology

Background:

  • Venetoclax (Ven), a BCL-2 inhibitor, shows promise for relapsed/refractory multiple myeloma (RRMM).
  • Clinical trial data on Ven efficacy, particularly in specific genetic subsets like t(11;14), remain inconclusive.
  • Understanding Venetoclax's real-world effectiveness in diverse RRMM patient populations is crucial.

Purpose of the Study:

  • To evaluate the efficacy and safety of Venetoclax-based therapies in RRMM patients without AL amyloidosis.
  • To assess the impact of the t(11;14) translocation and BCL-2 expression on treatment outcomes.
  • To identify factors, including cytogenetic abnormalities, influencing Venetoclax response and progression-free survival.

Main Methods:

  • Retrospective analysis of 232 RRMM patients treated with Venetoclax combinations from January 2015 to December 2023.
  • Stratification of patients based on t(11;14) status and assessment of BCL-2 expression.
  • Analysis of treatment regimens (Ven-Dex, PI-Ven, Daratumumab-Ven) and evaluation of overall response rate (ORR) and progression-free survival (PFS).

Main Results:

  • Overall response rate was 57%, with significantly higher ORR (64%) in t(11;14) patients compared to non-t(11;14) patients (26%).
  • Median PFS was 9.4 months overall, 11.8 months for t(11;14) patients, and 2.9 months for non-t(11;14) patients (p < 0.001).
  • In t(11;14) patients, high-risk cytogenetics (del(17p) or 1q gain/amplification) reduced PFS to 7.7 months.

Conclusions:

  • Venetoclax-based regimens are an important therapeutic option for RRMM patients with the t(11;14) translocation.
  • Efficacy of Venetoclax is limited in RRMM patients without t(11;14).
  • Secondary high-risk cytogenetic abnormalities significantly impair PFS in patients receiving Venetoclax.

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