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A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

NCT02755597 · Bellini Phase 3Completed

Lead sponsor
AbbVie (Industry)
Enrollment
291 (actual)
Start date
11 Jul 2016
Primary completion
15 Mar 2021 (actual)
Study completion
15 Aug 2022
Last update posted
22 Aug 2023

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Venetoclax Drug
  • Bortezomib Drug
  • Dexamethasone Drug
  • Placebo for venetoclax Drug

Conditions and primary outcome

  • Relapsed/Refractory Multiple Myeloma

Primary outcome

Progression-free Survival (PFS) (Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02755597 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression-free Survival (PFS)

    Time frame
    Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
    Measure
    Median
    Unit
    months

    • Venetoclax + Bortezomib and Dexamethasone vs Placebo + Bortezomib and DexamethasoneSuperiority

      Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)

      Estimate
      0.656Hazard Ratio (HR)
      95% CI, two-sided
      0.471 to 0.913
      p-value
      =0.012
      Method
      Log Rank

Serious adverse events

Time frame: All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days.

Participants with serious adverse events per group for Bellini, as posted
GroupAffectedAt risk
Venetoclax + Bortezomib and Dexamethasone115193
Placebo + Bortezomib and Dexamethasone5396

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. Venetoclax or placebo in combination with bortezomib and dexamethasone in relapsed or refractory multiple myeloma (BELLINI): final overall survival results from a randomised, phase 3 study.

    The Lancet. Haematology · 2025 Aug

    PubMed 40587991 (opens in a new tab)DOI 10.1016/S2352-3026(25)00139-5 (opens in a new tab)

  2. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial.

    The Lancet. Oncology · 2020 Dec

    PubMed 33129376 (opens in a new tab)DOI 10.1016/S1470-2045(20)30525-8 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.