DREAMM-3
Efficacy and safety of single-agent belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-3): a phase 3, open-label, randomised study
Phase 3N = 325NCT04162210
- Population
- Relapsed or refractory myeloma after two or more previous lines, including two or more consecutive cycles of both lenalidomide and a proteasome inhibitor, progressing on or within 60 days of the previous treatment.
- Design
- Open-label phase 3 study at 108 sites in 18 countries: 325 patients were randomly allocated 2:1 to belantamab mafodotin 2.5 mg per kg every 21 days or to pomalidomide and dexamethasone. The primary end point was progression-free survival in all randomly allocated patients. The primary analysis (data cutoff 12 September 2022) was followed by a final descriptive analysis (data cutoff 22 April 2025) with no formal hypothesis testing.
- Primary endpoint
- PFS
- Arms
- Belantamab mafodotin (experimental, n = 218): Belantamab mafodotin 2.5 mg per kg intravenously every 21 days
- Pomalidomide + dexamethasone (control, n = 107): Pomalidomide 4.0 mg on days 1 to 21 with dexamethasone 40.0 mg weekly in a 28-day cycle
- People
- Dimopoulos MA
Show the numbers
| Endpoint | Analysis | Belantamab mafodotin | Pomalidomide + dexamethasone | Effect |
|---|---|---|---|---|
| PFSRandomised patients (325) | primaryDimopoulos 2023 | median 11.2 months (6.4–14.5) | median 7 months (4.6–10.6) | HR 1.03 (95% CI 0.72–1.47)P=0.56Median follow-up was 11.5 months with belantamab mafodotin and 10.8 months with pomalidomide-dexamethasone. The abstract concludes that belantamab mafodotin was not associated with statistically improved progression-free survival. No treatment-related deaths occurred with belantamab mafodotin and one (1%) with pomalidomide-dexamethasone. |
| PFSRandomised patients (325) | finalDimopoulos 2026 | median 11.2 months (6.5–14.5) | median 7 months (4.6–10.6) | HR 0.87 (95% CI 0.64–1.18)Descriptive final analysis; no formal hypothesis testing was prespecified. The correspondence also cites a post-primary analysis hazard ratio of 0.90 (95% CI 0.65 to 1.24). Median follow-up (IQR) was 22.2 (7.0 to 45.7) and 21.9 (8.4 to 42.8) months. |
| OSRandomised patients (325) | finalDimopoulos 2026 | median 24 months (19.4–33.2) | median 22.9 months (16.0–29.3) | HR 0.98 (95% CI 0.73–1.30)Descriptive final analysis; the authors describe it as showing no overall survival detriment. |
| Endpoint | Analysis | Belantamab mafodotin | Pomalidomide + dexamethasone | Effect |
|---|---|---|---|---|
| PFSRandomised patients (325) | primaryDimopoulos 2023 | median 11.2 months (6.4–14.5) | median 7 months (4.6–10.6) | HR 1.03 (95% CI 0.72–1.47)P=0.56Median follow-up was 11.5 months with belantamab mafodotin and 10.8 months with pomalidomide-dexamethasone. The abstract concludes that belantamab mafodotin was not associated with statistically improved progression-free survival. No treatment-related deaths occurred with belantamab mafodotin and one (1%) with pomalidomide-dexamethasone. |
| PFSRandomised patients (325) | finalDimopoulos 2026 | median 11.2 months (6.5–14.5) | median 7 months (4.6–10.6) | HR 0.87 (95% CI 0.64–1.18)Descriptive final analysis; no formal hypothesis testing was prespecified. The correspondence also cites a post-primary analysis hazard ratio of 0.90 (95% CI 0.65 to 1.24). Median follow-up (IQR) was 22.2 (7.0 to 45.7) and 21.9 (8.4 to 42.8) months. |
| OSRandomised patients (325) | finalDimopoulos 2026 | median 24 months (19.4–33.2) | median 22.9 months (16.0–29.3) | HR 0.98 (95% CI 0.73–1.30)Descriptive final analysis; the authors describe it as showing no overall survival detriment. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 1.03 | 0.72–1.47 |
| PFS | 0.87 | 0.64–1.18 |
| OS | 0.98 | 0.73–1.3 |
- Belantamab mafodotin (experimental)
- Pomalidomide + dexamethasone (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Belantamab mafodotin | Pomalidomide + dexamethasone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 7 | 64.8% | 50.0% |
| 14 | 42.0% | 25.0% |
| 21 | 27.3% | 12.5% |
| 28 | 17.7% | 6.3% |
- Belantamab mafodotin (experimental)
- Pomalidomide + dexamethasone (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Belantamab mafodotin | Pomalidomide + dexamethasone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 7 | 64.8% | 50.0% |
| 14 | 42.0% | 25.0% |
| 21 | 27.3% | 12.5% |
| 28 | 17.7% | 6.3% |
Appears in
Sources
Dimopoulos MA, Hungria VTM, Radinoff A, Delimpasi S, Mikala G, Masszi T, et al. Efficacy and safety of single-agent belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-3): a phase 3, open-label, randomised study. Lancet Haematol. 2023;10(10):e801-e812.
Dimopoulos MA, Hungria V, Meng H, Radinoff A, Li J, Delimpasi S, et al. Final analysis results from DREAMM-3, a phase 3 study of belantamab mafodotin versus pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma. Blood Cancer J. 2026;16(1).