(Multiple Myeloma) Is Daratumumab (Darzalex) Plus Dexamethasone Effective? IFM 2014-04 Phase 2 Trial Results
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هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
- 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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