Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis
Phase meta-analysisN = 1,208
- Population
- Patients with newly diagnosed multiple myeloma who received autologous stem-cell transplantation (605 in the lenalidomide maintenance group and 603 in the placebo or observation group).
- Design
- Meta-analysis of primary-source patient-level data from three randomised trials of autologous stem-cell transplantation followed by lenalidomide maintenance versus placebo or observation (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell'Adulto RV-MM-PI-209 and Intergroupe Francophone du Myelome 2005-02). Trials had to be randomised, have patient-level data available and have reached database lock for the primary efficacy analysis.
- Arms
- Lenalidomide maintenance (experimental, n = 605): Lenalidomide maintenance after autologous stem-cell transplantation
- Placebo or observation (control, n = 603): Placebo or observation after autologous stem-cell transplantation
- People
- McCarthy PL
PFSHR 0.48 (95% CI 0.41–0.55)Δ median PFS+29.3 monthsOSHR 0.75 (95% CI 0.63–0.90)
Show the numbers
| Endpoint | Analysis | Lenalidomide maintenance | Placebo or observation | Effect |
|---|---|---|---|---|
| PFSPatients in the meta-analysis (1,208) | finalMcCarthy 2017 | median 52.8 months | median 23.5 months | HR 0.48 (95% CI 0.41–0.55) |
| OSPatients in the meta-analysis (1,208) | finalmedian follow-up 79.5 monthsMcCarthy 2017 | — | median 86 months | HR 0.75 (95% CI 0.63–0.90)P=0.001Median OS was not reached in the lenalidomide group. Median follow-up of 79.5 months is for all surviving patients. The cumulative incidence of a second primary malignancy before progression was higher with lenalidomide maintenance. |
| Endpoint | Analysis | Lenalidomide maintenance | Placebo or observation | Effect |
|---|---|---|---|---|
| PFSPatients in the meta-analysis (1,208) | finalMcCarthy 2017 | median 52.8 months | median 23.5 months | HR 0.48 (95% CI 0.41–0.55) |
| OSPatients in the meta-analysis (1,208) | finalmedian follow-up 79.5 monthsMcCarthy 2017 | — | median 86 months | HR 0.75 (95% CI 0.63–0.90)P=0.001Median OS was not reached in the lenalidomide group. Median follow-up of 79.5 months is for all surviving patients. The cumulative incidence of a second primary malignancy before progression was higher with lenalidomide maintenance. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.48 | 0.41–0.55 |
| OS | 0.75 | 0.63–0.9 |
- Lenalidomide maintenance (experimental)
- Placebo or observation (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Lenalidomide maintenance | Placebo or observation |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 33 | 64.8% | 37.8% |
| 66 | 42.0% | 14.3% |
| 99 | 27.3% | 5.4% |
| 132 | 17.7% | 2.0% |
- Placebo or observation (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Placebo or observation |
|---|---|
| 0 | 100.0% |
| 54 | 64.7% |
| 108 | 41.9% |
| 161 | 27.3% |
| 215 | 17.7% |