Skip to content
Bending the Curve Trial by Trial
?

IFM 2005-02

Lenalidomide maintenance after stem-cell transplantation for multiple myeloma

Phase 3N = 614NCT00430365

Population
Patients younger than 65 years of age with myeloma and nonprogressive disease after first-line autologous stem-cell transplantation.
Design
Phase 3, placebo-controlled trial in 614 patients younger than 65 years of age with nonprogressive disease after first-line transplantation, randomly assigned to maintenance with lenalidomide (10 mg per day for the first 3 months, increased to 15 mg if tolerated) or placebo until relapse. The primary end point was progression-free survival.
Primary endpoint
PFS
Arms
  • Lenalidomide maintenance (experimental): Lenalidomide 10 mg per day for 3 months, increased to 15 mg if tolerated, until relapse
  • Placebo (control): Placebo until relapse
People
Attal M
PFSHR 0.5Δ median PFS+18 monthsΔ median EFS+17 months
Show the numbers
Results reported for IFM 2005-02
EndpointAnalysisLenalidomide maintenancePlaceboEffect
PFSRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 45 monthsAttal 2012median 41 monthsmedian 23 monthsHR 0.5P<0.001
EFSRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 45 monthsAttal 2012median 40 monthsmedian 23 monthsP<0.001Events included second primary cancers. The incidence of second primary cancers was 3.1 per 100 patient-years with lenalidomide versus 1.2 with placebo (P=0.002). More than 70% of patients in both groups were alive at 4 years.
Results reported for IFM 2005-02
EndpointAnalysisLenalidomide maintenancePlaceboEffect
PFSRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 45 monthsAttal 2012median 41 monthsmedian 23 monthsHR 0.5P<0.001
EFSRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 45 monthsAttal 2012median 40 monthsmedian 23 monthsP<0.001Events included second primary cancers. The incidence of second primary cancers was 3.1 per 100 patient-years with lenalidomide versus 1.2 with placebo (P=0.002). More than 70% of patients in both groups were alive at 4 years.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Lenalidomide maintenance (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsLenalidomide maintenancePlacebo
0100.0%100.0%
2664.4%45.7%
5142.2%21.5%
7727.2%9.8%
10317.5%4.5%
Illustrative — modelled from reported values, not trial data. EFS, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Lenalidomide maintenance (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsLenalidomide maintenancePlacebo
0100.0%100.0%
2564.8%47.1%
5042.0%22.2%
7527.3%10.4%
10017.7%4.9%
Primary publication: Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, et al. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1782-91. PubMedDOI

Appears in

Sources

  1. Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, et al. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1782-91.

    PubMedDOI