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Bending the Curve Trial by Trial
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MM-010

Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma

Phase 3N = 351NCT00424047

Population
Patients with relapsed or refractory myeloma who had received at least one previous antimyeloma therapy.
Design
Phase 3, placebo-controlled trial in 351 patients who had received at least one previous antimyeloma therapy: 176 were randomly assigned to oral lenalidomide 25 mg and 175 to placebo, on days 1 to 21 of a 28-day cycle, with dexamethasone 40 mg on days 1-4, 9-12 and 17-20 for the first four cycles and on days 1-4 thereafter. Treatment continued until progression or unacceptable toxic effects. The primary end point was time to progression.
Primary endpoint
TTP
Arms
  • Lenalidomide plus dexamethasone (experimental, n = 176): Lenalidomide 25 mg days 1-21 of 28 plus dexamethasone 40 mg
  • Placebo plus dexamethasone (control, n = 175): Placebo days 1-21 of 28 plus dexamethasone 40 mg
People
Dimopoulos M
Δ median TTP+6.6 monthsΔ CR+PR rate+36.2 pointsOSHR 0.66
Show the numbers
Results reported for MM-010
EndpointAnalysisLenalidomide plus dexamethasonePlacebo plus dexamethasoneEffect
TTPRandomised patients (analysis population not stated in the abstract)primaryDimopoulos 2007median 11.3 monthsmedian 4.7 monthsP<0.001
CR+PR rateRandomised patients (analysis population not stated in the abstract)primaryDimopoulos 200760.2%24%P<0.001106 versus 42 patients. Complete response 15.9% versus 3.4% (P<0.001). Grade 3 or 4 neutropenia 29.5% versus 2.3%, thrombocytopenia 11.4% versus 5.7%, venous thromboembolism 11.4% versus 4.6%.
OSRandomised patients (analysis population not stated in the abstract)primaryDimopoulos 2007——HR 0.66P=0.03
Results reported for MM-010
EndpointAnalysisLenalidomide plus dexamethasonePlacebo plus dexamethasoneEffect
TTPRandomised patients (analysis population not stated in the abstract)primaryDimopoulos 2007median 11.3 monthsmedian 4.7 monthsP<0.001
CR+PR rateRandomised patients (analysis population not stated in the abstract)primaryDimopoulos 200760.2%24%P<0.001106 versus 42 patients. Complete response 15.9% versus 3.4% (P<0.001). Grade 3 or 4 neutropenia 29.5% versus 2.3%, thrombocytopenia 11.4% versus 5.7%, venous thromboembolism 11.4% versus 4.6%.
OSRandomised patients (analysis population not stated in the abstract)primaryDimopoulos 2007——HR 0.66P=0.03
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%
765.1%35.6%
1442.4%12.7%
2127.6%4.5%
2818.0%1.6%
Primary publication: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007;357(21):2123-32. PubMedDOI

Appears in

Sources

  1. Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007;357(21):2123-32.

    PubMedDOI