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Bending the Curve Trial by Trial
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CASTOR

Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma (CASTOR)

Phase 3N = 498NCT02136134

Population
Relapsed or relapsed and refractory multiple myeloma.
Design
Phase 3 trial: 498 patients with relapsed or relapsed and refractory myeloma were randomly assigned to bortezomib and dexamethasone alone (control) or with daratumumab. The primary end point was progression-free survival; the results reported here are from a prespecified interim analysis.
Primary endpoint
PFS
Arms
  • Daratumumab + bortezomib + dexamethasone (experimental): Daratumumab 16 mg per kg of body weight with bortezomib 1.3 mg per square metre and dexamethasone 20 mg
  • Bortezomib + dexamethasone (control): Bortezomib 1.3 mg per square metre and dexamethasone 20 mg
People
Palumbo A, CASTOR Investigators
PFSHR 0.39 (95% CI 0.28–0.53)Δ 12-month PFS+33.8 pointsΔ ORR+19.7 pointsΔ ≥CR rate+10.2 points
Show the numbers
Results reported for CASTOR
EndpointAnalysisDaratumumab + bortezomib + dexamethasoneBortezomib + dexamethasoneEffect
PFSRandomised patients (498)interimmedian follow-up 7.4 monthsPalumbo 201660.7% at 12 momedian 7.2 months; 26.9% at 12 moHR 0.39 (95% CI 0.28–0.53)P<0.001Median progression-free survival was not reached in the daratumumab group. Grade 3 or 4 thrombocytopenia 45.3% versus 32.9%; neutropenia 12.8% versus 4.2%; infusion-related reactions with daratumumab 45.3% (grade 3 in 8.6%).
ORRRandomised patients (498)interimPalumbo 201682.9%63.2%P<0.001
≥CR rateRandomised patients (498)interimPalumbo 201619.2%9%P=0.001
Results reported for CASTOR
EndpointAnalysisDaratumumab + bortezomib + dexamethasoneBortezomib + dexamethasoneEffect
PFSRandomised patients (498)interimmedian follow-up 7.4 monthsPalumbo 201660.7% at 12 momedian 7.2 months; 26.9% at 12 moHR 0.39 (95% CI 0.28–0.53)P<0.001Median progression-free survival was not reached in the daratumumab group. Grade 3 or 4 thrombocytopenia 45.3% versus 32.9%; neutropenia 12.8% versus 4.2%; infusion-related reactions with daratumumab 45.3% (grade 3 in 8.6%).
ORRRandomised patients (498)interimPalumbo 201682.9%63.2%P<0.001
≥CR rateRandomised patients (498)interimPalumbo 201619.2%9%P=0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.390.28–0.53
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%051015Months (modelled)
  • Bortezomib + dexamethasone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsBortezomib + dexamethasone
0100.0%
561.8%
942.0%
1426.0%
1817.7%
Primary publication: Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375(8):754-66. PubMedDOI

Appears in

Sources

  1. Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375(8):754-66.

    PubMedDOI