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    Association details:
    Biomarker:Chr t(11;14)
    Cancer:Multiple Myeloma
    Drug:Venclexta (venetoclax) (Bcl2 inhibitor) +
    bortezomib (Proteasome inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASH 2021
    Title:

    Final Overall Survival Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma

    Published date:
    11/04/2021
    Excerpt:
    BELLINI (NCT02755597) is a Phase 3, randomized, double-blind, multicenter study of Ven or Pbo combined with bortezomib and dexamethasone in pts with RRMM who had received 1–3 prior lines of therapy and were either sensitive or naïve to proteasome inhibitors. Pts were randomized 2:1 to receive Ven 800 mg/day or Pbo plus bortezomib and dexamethasone....Consistent with results from previous analyses, Ven added to bortezomib and dexamethasone showed the greatest PFS improvement in pts with t(11;14) or high BCL2, with a favorable benefit-risk profile.
    DOI:
    10.1182/blood-2021-145757
    Trial ID:
    BELLINI
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASH 2019
    Title:

    T(11;14) and High BCL2 Expression Are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 Bellini Study

    Published date:
    11/06/2019
    Excerpt:
    Adding Ven to Bd demonstrates significant efficacy in pts with RRMM harboring either t(11;14) or tumor cells expressing high levels of BCL2.
    DOI:
    https://doi.org/10.1182/blood-2019-126094
    Trial ID:
    BELLINI
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2020
    Title:

    UPDATED RESULTS FROM A PHASE 1/2 STUDY OF VENETOCLAX IN COMBINATION WITH DARATUMUMAB AND DEXAMETHASONE, +/- BORTEZOMIB, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

    Published date:
    06/12/2020
    Excerpt:
    Pts treated with VenDd +/- V continue to demonstrate a tolerable safety profile with encouraging efficacy, notably among pts with t(11;14) treated with VenDd.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Br J Haematol
    Title:

    Real-world data on safety and efficacy of venetoclax-based regimens in relapsed/refractory t(11;14) multiple myeloma

    Published date:
    02/03/2020
    Excerpt:
    Here, we report additional real‐world experience with venetoclax‐based regimens in patients with t(11:14) RRMM at our institution….The most common regimen used was venetoclax in combination with bortezomib and dexamethasone....Among nine patients who were evaluable for response, the ORR was 78% (seven out of nine patients)...Notably, the best responses were seen in those patients who received carfilzomib and dexamethasone in addition to venetoclax.
    DOI:
    10.1111/bjh.16454