DREAMM-2
Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study
Phase 2N = 196NCT03525678
- Population
- Relapsed or refractory myeloma with progression after three or more lines, refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant to an anti-CD38 antibody.
- Design
- Open-label, two-arm randomised phase 2 study at 58 centres in eight countries: patients were randomly assigned 1:1 to belantamab mafodotin 2.5 mg per kg or 3.4 mg per kg every 3 weeks until progression or unacceptable toxicity. The primary outcome was the proportion in the intention-to-treat population with an overall response, assessed by an independent review committee.
- Primary endpoint
- ORR
- Arms
- Belantamab mafodotin 2.5 mg/kg (experimental, n = 97): Belantamab mafodotin 2.5 mg per kg intravenously every 3 weeks
- Belantamab mafodotin 3.4 mg/kg (experimental, n = 99): Belantamab mafodotin 3.4 mg per kg intravenously every 3 weeks
- People
- Lonial S
Show the numbers
| Endpoint | Analysis | Belantamab mafodotin 2.5 mg/kg / Belantamab mafodotin 3.4 mg/kg | Control | Effect |
|---|---|---|---|---|
| ORRITT population (196) | primaryLonial 2020 | 31% | — | The confidence intervals are 97.5% intervals: 20.8 to 42.6 at 2.5 mg per kg and 23.9 to 46.0 at 3.4 mg per kg. The most common grade 3-4 adverse event was keratopathy (26 [27%] of 95 patients at 2.5 mg per kg and 21 [21%] of 99 at 3.4 mg per kg). Two deaths were potentially treatment related. |
| Endpoint | Analysis | Belantamab mafodotin 2.5 mg/kg / Belantamab mafodotin 3.4 mg/kg | Control | Effect |
|---|---|---|---|---|
| ORRITT population (196) | primaryLonial 2020 | 31% | — | The confidence intervals are 97.5% intervals: 20.8 to 42.6 at 2.5 mg per kg and 23.9 to 46.0 at 3.4 mg per kg. The most common grade 3-4 adverse event was keratopathy (26 [27%] of 95 patients at 2.5 mg per kg and 21 [21%] of 99 at 3.4 mg per kg). Two deaths were potentially treatment related. |