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Bending the Curve Trial by Trial
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QUIREDEX

Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma

Phase 3N = 119NCT00480363

Population
Patients with high-risk smoldering multiple myeloma
Design
Randomised, open-label phase 3 trial. Treatment group: induction with lenalidomide 25 mg a day on days 1 to 21 plus dexamethasone 20 mg a day on days 1 to 4 and 12 to 15 at 4-week intervals for nine cycles, then lenalidomide 10 mg a day on days 1 to 21 of each 28-day cycle for 2 years. Control group: observation.
Primary endpoint
TTP
Arms
  • Lenalidomide plus dexamethasone (experimental): Induction lenalidomide plus dexamethasone for nine cycles, then lenalidomide maintenance for 2 years
  • Observation (control): Observation until symptomatic disease
People
Mateos MV
TTPHR 0.18 (95% CI 0.09–0.32)OSHR 0.31 (95% CI 0.10–0.91)Δ 36-month OS+14 points
Show the numbers
Results reported for QUIREDEX
EndpointAnalysisLenalidomide plus dexamethasoneObservationEffect
TTPRandomly assigned patients (119)Time to progression to symptomatic diseaseprimarymedian follow-up 40 monthsMateos 2013—median 21 monthsHR 0.18 (95% CI 0.09–0.32)P<0.001Hazard ratio for progression. The median was not reached in the lenalidomide plus dexamethasone group. Control median of 21 months is as reported in the abstract.
OSRandomly assigned patients (119)primarymedian follow-up 40 monthsMateos 201394% at 3 y80% at 3 yHR 0.31 (95% CI 0.10–0.91)P=0.03Secondary end point (overall survival). Hazard ratio is for death. Three-year survival rate as stated in the abstract.
Results reported for QUIREDEX
EndpointAnalysisLenalidomide plus dexamethasoneObservationEffect
TTPRandomly assigned patients (119)Time to progression to symptomatic diseaseprimarymedian follow-up 40 monthsMateos 2013—median 21 monthsHR 0.18 (95% CI 0.09–0.32)P<0.001Hazard ratio for progression. The median was not reached in the lenalidomide plus dexamethasone group. Control median of 21 months is as reported in the abstract.
OSRandomly assigned patients (119)primarymedian follow-up 40 monthsMateos 201394% at 3 y80% at 3 yHR 0.31 (95% CI 0.10–0.91)P=0.03Secondary end point (overall survival). Hazard ratio is for death. Three-year survival rate as stated in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
TTPOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
TTP0.180.09–0.32
OS0.310.1–0.91
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Observation (control)

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

Data table (modelled values)
MonthsObservation
0100.0%
1365.1%
2642.4%
3927.6%
5317.4%
Primary publication: Mateos MV, Hernández MT, Giraldo P, de la Rubia J, de Arriba F, López Corral L, et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013;369(5):438-47. PubMedDOI

Appears in

Sources

  1. Mateos MV, Hernández MT, Giraldo P, de la Rubia J, de Arriba F, López Corral L, et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013;369(5):438-47.

    PubMedDOI