(Multiple Myeloma) Is Daratumumab (Darzalex) Plus Dexamethasone Effective? IFM 2014-04 Phase 2 Trial Results
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- August 23, 2019
- 2 min read
On June 19, 2019, Eileen M. Boyle published results in the British Journal of Haematology from the IFM 2014-04 Phase 2 clinical trial evaluating the efficacy and safety of daratumumab (anti-CD38 monoclonal antibody) plus dexamethasone in relapsed/refractory multiple myeloma patients with prior bortezomib, lenalidomide, and pomalidomide therapy.
Background:
Prior clinical trials had confirmed a 29.2% anti-tumor response rate with daratumumab monotherapy in relapsed/refractory multiple myeloma patients. The IFM 2014-04 trial was initiated to evaluate whether daratumumab combined with dexamethasone could improve outcomes.
Trial Design:
Phase 2 trial with a 28-day treatment cycle: Daratumumab 16 mg/kg (once weekly in Cycles 1–2, once every 2 weeks in Cycles 3–6, once monthly from Cycle 7 onwards) + dexamethasone 40 mg once weekly. Primary endpoints: ORR, duration of response, PFS, and OS.
Patient Demographics (N=64):
| Parameter | Value |
|---|---|
| Median age | 67 years (range 30–80) |
| IgA | 21% (N=12) |
| IgG | 66% (N=38) |
| Myeloma Stage 1/2/3 | 47%/30%/24% |
| ECOG 0/1/2 | 17%/58%/25% |
| Median time since diagnosis | 6.6 years (0.82–22 years) |
| Median prior treatment lines | 6 (range 3–10) |
Results (N=57 evaluable):
Primary endpoint ORR: 33%
- Stringent complete response: 1.75% (N=1)
- Very good partial response: 7.02% (N=4)
- Partial response: 25% (N=14)
- Minimal response: 14% (N=8)
- Stable disease: 33.3% (N=19)
- Progressive disease: 19% (N=11)
Secondary endpoints:
- Median PFS: 4.17 months; median PFS for ≥PR patients: 6.6 months; median PFS for MR/SD patients: 3.7 months
- Median OS: 16.7 months; median OS for ≥PR patients: 23.7 months; median OS for MR/SD patients: 17.7 months
Safety:
Most common adverse events: cytopenia, fatigue, infusion-related reactions. Most common Grade 3+ adverse events: anemia 33%, neutropenia 26%, thrombocytopenia 17%, hypertension 5%.
Conclusion: Based on the IFM 2014-04 trial results, Eileen M. Boyle concluded that daratumumab plus dexamethasone achieved a 33% ORR with durable anti-tumor activity in triple-refractory relapsed/refractory multiple myeloma patients.
Source: Daratumumab and dexamethasone is safe and effective for triple refractory myeloma patients: final results of the IFM 2014-04 (Etoile du Nord) trial. Br J Haematol. 2019 Jun 19. doi:10.1111/bjh.16059.
Multiple Myeloma | Daratumumab | Dexamethasone | IFM 2014-04
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