(Multiple Myeloma) Is Daratumumab (Darzalex) Plus Dexamethasone Effective? IFM 2014-04 Phase 2 Trial Results

• 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):

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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