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Bending the Curve Trial by Trial
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CALGB 100104

Lenalidomide after stem-cell transplantation for multiple myeloma

N = 460NCT00114101

Population
Patients younger than 71 years of age with myeloma and stable disease or a marginal, partial or complete response 100 days after autologous stem-cell transplantation.
Design
Randomised, placebo-controlled trial between April 2005 and July 2009 in 460 patients younger than 71 years of age with stable disease or a marginal, partial or complete response 100 days after stem-cell transplantation, assigned to lenalidomide (starting dose 10 mg per day, range 5 to 15) or placebo until disease progression. Study-drug assignments were unblinded in 2009 after a planned interim analysis; 86 of 128 placebo patients without progression crossed over to lenalidomide.
Primary endpoint
TTP
Arms
  • Lenalidomide maintenance (experimental, n = 231): Lenalidomide starting at 10 mg per day (range 5 to 15) until progression
  • Placebo (control, n = 229): Placebo until progression
People
McCarthy PL
Δ median TTP+19 monthsΔ All-cause mortality−8 points
Show the numbers
Results reported for CALGB 100104
EndpointAnalysisLenalidomide maintenancePlaceboEffect
TTPRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 34 monthsMcCarthy 2012median 46 monthsmedian 27 monthsP<0.001At a median follow-up of 34 months, 86 of 231 patients (37%) given lenalidomide and 132 of 229 (58%) given placebo had disease progression or had died. Second primary cancers occurred in 18 patients (8%) given lenalidomide and 6 (3%) given placebo. The full text states that the primary end point was time to progression.
All-cause mortalityRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 34 monthsMcCarthy 201215%23%P=0.0335 versus 53 deaths at a median follow-up of 34 months; these counts follow the unblinding and crossover described in the design.
Results reported for CALGB 100104
EndpointAnalysisLenalidomide maintenancePlaceboEffect
TTPRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 34 monthsMcCarthy 2012median 46 monthsmedian 27 monthsP<0.001At a median follow-up of 34 months, 86 of 231 patients (37%) given lenalidomide and 132 of 229 (58%) given placebo had disease progression or had died. Second primary cancers occurred in 18 patients (8%) given lenalidomide and 6 (3%) given placebo. The full text states that the primary end point was time to progression.
All-cause mortalityRandomised patients (analysis population not stated in the abstract)primarymedian follow-up 34 monthsMcCarthy 201215%23%P=0.0335 versus 53 deaths at a median follow-up of 34 months; these counts follow the unblinding and crossover described in the design.
Illustrative — modelled from reported values, not trial data. TTP, 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%
2964.6%47.5%
5841.7%22.6%
8627.4%11.0%
11517.7%5.2%
Primary publication: McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1770-81. PubMedDOI

Appears in

Sources

  1. McCarthy PL, Owzar K, Hofmeister CC, Hurd DD, Hassoun H, Richardson PG, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1770-81.

    PubMedDOI