BELLINI
Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI)
Phase 3N = 291NCT02755597
- Population
- Relapsed or refractory multiple myeloma after one to three previous therapies, ECOG performance status 2 or less; not restricted to patients with t(11;14).
- Design
- Randomised, double-blind, multicentre phase 3 trial at 90 hospitals in 16 countries: 291 patients with one to three previous therapies were randomly assigned 2:1 to venetoclax 800 mg daily or placebo, each with bortezomib and dexamethasone. The primary end point was independent review committee-assessed progression-free survival in the intention-to-treat population. The primary report (Lancet Oncology 2020) and the final overall survival report (Lancet Haematology 2025) are separate analyses.
- Primary endpoint
- PFS
- Arms
- Venetoclax + Vd (experimental, n = 194): Venetoclax 800 mg orally daily with bortezomib and dexamethasone
- Placebo + Vd (control, n = 97): Placebo with bortezomib and dexamethasone
- People
- Kumar SK
PFSHR 0.63 (95% CI 0.44–0.90)Δ median PFS+10.9 monthsOSHR 1.19 (95% CI 0.80–1.77)PFSHR 0.58 (95% CI 0.43–0.78)Δ median PFS+12 months
Show the numbers
| Endpoint | Analysis | Venetoclax + Vd | Placebo + Vd | Effect |
|---|---|---|---|---|
| PFSITT population (291) | primarymedian follow-up 18.7 monthsKumar 2020 | median 22.4 months | median 11.5 months (9.6–15.0) | HR 0.63 (95% CI 0.44–0.90)P=0.010The 95% CI of the venetoclax median is 15.3 months to not estimable (lower bound only). Eight (4%) treatment-emergent fatal infections were reported in the venetoclax group and none in the placebo group; three deaths in the venetoclax group (two from pneumonia, one from septic shock) were considered treatment-related. The abstract states that increased mortality was seen in the venetoclax group, mostly because of an increased rate of infections. |
| OSITT population (291) | finalmedian follow-up 45.6 monthsKumar 2025 | — | — | HR 1.19 (95% CI 0.80–1.77)P=0.39Median overall survival was not reached in either group (95% CI 44.4 months to not estimable with venetoclax; 44.0 months to not estimable with placebo). Treatment-related adverse events led to death in 4 (2%) of 193 patients in the venetoclax group and none in the placebo group. The authors' interpretation is that overall survival favoured placebo and venetoclax use should be avoided in the general relapsed or refractory population. |
| PFSITT population (291) | finalmedian follow-up 45.6 monthsKumar 2025 | median 23.4 months (16.2–26.4) | median 11.4 months (9.5–14.6) | HR 0.58 (95% CI 0.43–0.78)P=0.00026Investigator-assessed progression-free survival in the final overall survival report. |
| Endpoint | Analysis | Venetoclax + Vd | Placebo + Vd | Effect |
|---|---|---|---|---|
| PFSITT population (291) | primarymedian follow-up 18.7 monthsKumar 2020 | median 22.4 months | median 11.5 months (9.6–15.0) | HR 0.63 (95% CI 0.44–0.90)P=0.010The 95% CI of the venetoclax median is 15.3 months to not estimable (lower bound only). Eight (4%) treatment-emergent fatal infections were reported in the venetoclax group and none in the placebo group; three deaths in the venetoclax group (two from pneumonia, one from septic shock) were considered treatment-related. The abstract states that increased mortality was seen in the venetoclax group, mostly because of an increased rate of infections. |
| OSITT population (291) | finalmedian follow-up 45.6 monthsKumar 2025 | — | — | HR 1.19 (95% CI 0.80–1.77)P=0.39Median overall survival was not reached in either group (95% CI 44.4 months to not estimable with venetoclax; 44.0 months to not estimable with placebo). Treatment-related adverse events led to death in 4 (2%) of 193 patients in the venetoclax group and none in the placebo group. The authors' interpretation is that overall survival favoured placebo and venetoclax use should be avoided in the general relapsed or refractory population. |
| PFSITT population (291) | finalmedian follow-up 45.6 monthsKumar 2025 | median 23.4 months (16.2–26.4) | median 11.4 months (9.5–14.6) | HR 0.58 (95% CI 0.43–0.78)P=0.00026Investigator-assessed progression-free survival in the final overall survival report. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.63 | 0.44–0.9 |
| OS | 1.19 | 0.8–1.77 |
| PFS | 0.58 | 0.43–0.78 |
- Venetoclax + Vd (experimental)
- Placebo + Vd (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Venetoclax + Vd | Placebo + Vd |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 14 | 64.8% | 43.0% |
| 28 | 42.0% | 18.5% |
| 42 | 27.3% | 8.0% |
| 56 | 17.7% | 3.4% |
- Venetoclax + Vd (experimental)
- Placebo + Vd (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Venetoclax + Vd | Placebo + Vd |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 15 | 64.1% | 40.2% |
| 29 | 42.4% | 17.1% |
| 44 | 27.2% | 6.9% |
| 59 | 17.4% | 2.8% |
Appears in
Sources
Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, et al. 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. Lancet Oncol. 2020;21(12):1630-1642.
Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, et al. 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. Lancet Haematol. 2025;12(8):e574-e587.