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Bending the Curve Trial by Trial
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MM-009

Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America

Phase 3N = 353NCT00056160

Population
Patients in the United States and Canada with myeloma who had received at least one previous therapy and required additional treatment.
Design
Randomised, placebo-controlled comparison in patients in the United States and Canada who had received at least one previous therapy for myeloma and required additional treatment. 177 patients were assigned to lenalidomide 25 mg and 176 to placebo, on days 1 to 21 of a 28-day cycle; both groups received dexamethasone 40 mg on days 1-4, 9-12 and 17-20 for the first four cycles and on days 1-4 thereafter. Safety, response, time to progression and overall survival were assessed.
Primary endpoint
TTP
Arms
  • Lenalidomide plus dexamethasone (experimental, n = 177): Lenalidomide 25 mg days 1-21 of 28 plus dexamethasone 40 mg
  • Placebo plus dexamethasone (control, n = 176): Placebo days 1-21 of 28 plus dexamethasone 40 mg
People
Weber DM
Δ median TTP+6.4 monthsΔ ORR+41.1 pointsΔ CR rate+13.5 pointsΔ median OS+9.4 months
Show the numbers
Results reported for MM-009
EndpointAnalysisLenalidomide plus dexamethasonePlacebo plus dexamethasoneEffect
TTPRandomised patients (analysis population not stated in the abstract)primaryWeber 2007median 11.1 monthsmedian 4.7 monthsP<0.001
ORRRandomised patients (analysis population not stated in the abstract)Complete, near-complete or partial response.primaryWeber 200761%19.9%P<0.001108 versus 35 patients. Grade 3 or 4 neutropenia 41.2% versus 4.6% and venous thromboembolism 14.7% versus 3.4% (P<0.001 for both); study discontinuation for adverse events 19.8% versus 10.2%.
CR rateRandomised patients (analysis population not stated in the abstract)primaryWeber 200714.1%0.6%P<0.001
OSRandomised patients (analysis population not stated in the abstract)primaryWeber 2007median 29.6 monthsmedian 20.2 monthsP<0.001
Results reported for MM-009
EndpointAnalysisLenalidomide plus dexamethasonePlacebo plus dexamethasoneEffect
TTPRandomised patients (analysis population not stated in the abstract)primaryWeber 2007median 11.1 monthsmedian 4.7 monthsP<0.001
ORRRandomised patients (analysis population not stated in the abstract)Complete, near-complete or partial response.primaryWeber 200761%19.9%P<0.001108 versus 35 patients. Grade 3 or 4 neutropenia 41.2% versus 4.6% and venous thromboembolism 14.7% versus 3.4% (P<0.001 for both); study discontinuation for adverse events 19.8% versus 10.2%.
CR rateRandomised patients (analysis population not stated in the abstract)primaryWeber 200714.1%0.6%P<0.001
OSRandomised patients (analysis population not stated in the abstract)primaryWeber 2007median 29.6 monthsmedian 20.2 monthsP<0.001
Illustrative — modelled from reported values, not trial data. TTP, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Lenalidomide plus dexamethasone (experimental)
  • Placebo plus dexamethasone (control)

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

Data table (modelled values)
MonthsLenalidomide plus dexamethasonePlacebo plus dexamethasone
0100.0%100.0%
764.6%35.6%
1441.7%12.7%
2126.9%4.5%
2817.4%1.6%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0204060Months (modelled)
  • Lenalidomide plus dexamethasone (experimental)
  • Placebo plus dexamethasone (control)

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

Data table (modelled values)
MonthsLenalidomide plus dexamethasonePlacebo plus dexamethasone
0100.0%100.0%
1964.1%52.1%
3742.0%28.1%
5626.9%14.6%
7417.7%7.9%
Primary publication: Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007;357(21):2133-42. PubMedDOI

Appears in

Sources

  1. Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007;357(21):2133-42.

    PubMedDOI