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Bending the Curve Trial by Trial
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E3A06

Randomized trial of lenalidomide versus observation in smoldering multiple myeloma

Phase 3N = 182NCT01169337

Population
Patients with intermediate- or high-risk smoldering multiple myeloma
Design
Randomised trial comparing single-agent lenalidomide with observation. Lenalidomide 25 mg orally on days 1 to 21 of a 28-day cycle.
Primary endpoint
PFS
Arms
  • Lenalidomide (experimental, n = 92): Lenalidomide 25 mg orally on days 1 to 21 of a 28-day cycle
  • Observation (control, n = 90): Observation
People
Lonial S
PFSHR 0.28 (95% CI 0.12–0.62)Δ 12-month PFS+9 pointsOSHR 0.46 (95% CI 0.08–2.53)
Show the numbers
Results reported for E3A06
EndpointAnalysisLenalidomideObservationEffect
PFSRandomly assigned patients (182)Progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression (as worded in the abstract)primarymedian follow-up 35 monthsLonial 202098% at 12 mo; 93% at 2 y; 91% at 3 y89% at 12 mo; 76% at 2 y; 66% at 3 yHR 0.28 (95% CI 0.12–0.62)P=.002Landmarks are the 1-, 2- and 3-year progression-free survival rates in the abstract.
ORRRandomly assigned patients (182)primarymedian follow-up 35 monthsLonial 202050% (39–61%)—Response to therapy; the abstract does not define the response criteria and reports no responses in the observation arm.
OSRandomly assigned patients (182)primarymedian follow-up 35 monthsLonial 2020——HR 0.46 (95% CI 0.08–2.53)Hazard ratio for death. Six deaths were reported at the time of the abstract: two in the lenalidomide arm and four in the observation arm.
Results reported for E3A06
EndpointAnalysisLenalidomideObservationEffect
PFSRandomly assigned patients (182)Progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression (as worded in the abstract)primarymedian follow-up 35 monthsLonial 202098% at 12 mo; 93% at 2 y; 91% at 3 y89% at 12 mo; 76% at 2 y; 66% at 3 yHR 0.28 (95% CI 0.12–0.62)P=.002Landmarks are the 1-, 2- and 3-year progression-free survival rates in the abstract.
ORRRandomly assigned patients (182)primarymedian follow-up 35 monthsLonial 202050% (39–61%)—Response to therapy; the abstract does not define the response criteria and reports no responses in the observation arm.
OSRandomly assigned patients (182)primarymedian follow-up 35 monthsLonial 2020——HR 0.46 (95% CI 0.08–2.53)Hazard ratio for death. Six deaths were reported at the time of the abstract: two in the lenalidomide arm and four in the observation arm.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.280.12–0.62
OS0.460.08–2.53
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Lenalidomide (experimental)
  • Observation (control)
Data table (modelled values)
MonthsLenalidomideObservation
0100.0%100.0%
1098.5%90.9%
1995.0%81.3%
2992.0%71.6%
3991.0%66.0%
Primary publication: Lonial S, Jacobus S, Fonseca R, Weiss M, Kumar S, Orlowski RZ, et al. Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma. J Clin Oncol. 2020;38(11):1126-1137. PubMedDOI

Appears in

Sources

  1. Lonial S, Jacobus S, Fonseca R, Weiss M, Kumar S, Orlowski RZ, et al. Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma. J Clin Oncol. 2020;38(11):1126-1137.

    PubMedDOI