Lenalidomide treatment for multiple myeloma: systematic review and meta-analysis of randomized controlled trials

Abstract

Background: In recent years, a number of randomized controlled trials (RCTs) have reported on lenalidomide as a treatment for multiple myeloma (MM). Herein, we report results of a meta-analysis of RCTs examining the efficacy and safety of lenalidomide for MM.

Patients and methods: Databases were searched using the terms "lenalidomide or revlimid AND multiple myeloma."RCTs evaluating initial or maintenance therapeutic outcomes were included. Main outcome measures were response rates, progression-free survival (PFS), overall survival, and adverse events.

Results: Seven trials were included (N = 192-614 participants). Lenalidomide doses and treatment regimens differed between trials. Complete response (CR) and very good partial response (VGPR) risk ratios (RR) favored lenalidomide over placebo (CR = 2.54, 95% confidence interval [CI] = 1.29-5.02; VGPR = 2.82, 95% CI = 1.30-6.09). The PFS hazard ratio favored lenalidomide over placebo (0.37, 95% CI = 0.33-0.41). For adverse events, neutropenia, deep vein thrombosis (DVT), infection, and hematologic cancer RR favored placebo over lenalidomide (neutropenia: 4.74, 95% CI = 2.96-7.57; DVT: 2.52; 95% CI: 1.60-3.98; infection: 1.98; 95% CI: 1.50-2.62; hematologic cancer: 3.20; 95% CI: 1.28-7.98).

Conclusions: Lenalidomide is an effective treatment for MM; however, treatment-related adverse events must be considered and appropriate adjustments and/or prophylactic treatment should be initiated where possible.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Flowchart of the selection of studies.

Figure 2. Individual trials and overall risk ratios for response rates (complete response, very good partial response, and partial response) in the comparison of lenalidomide and placebo.

Squares on the risk ratio plot are proportional to the weight of each study, which is based on the Mantel-Haenszel (M-H) method. Risk ratios are presented with 95% confidence intervals (CIs).

Figure 3. Individual trials and overall hazard ratios for progression-free survival in the comparison of lenalidomide and placebo.

Squares on the hazard ratio plot are proportional to the weight of each study, which is based on the inverse variance (IV) method. Hazard ratios are presented with 95% confidence intervals (CIs).

Figure 4. Individual trials and overall hazard ratios for overall survival in the comparison of lenalidomide and placebo.

Squares on the hazard ratio plot are proportional to the weight of each study, which is based on the inverse variance (IV) method. Hazard ratios are presented with 95% confidence intervals (CIs).

Figure 5. Individual trials and overall risk ratios for the incidence of adverse events (neutropenia, anemia, thrombocytopenia, deep vein thrombosis, peripheral neuropathy, and infection) in the comparison of lenalidomide and placebo.

Squares on the risk ratio plot are proportional to the weight of each study, which is based on the Mantel-Haenszel (M-H) method. Risk ratios are presented with 95% confidence intervals (CIs).

Figure 6. Individual trials and overall risk ratios for the incidence of second primary cancers in the comparison of lenalidomide and placebo.

Squares on the risk ratio plot are proportional to the weight of each study, which is based on the Mantel-Haenszel (M-H) method. Risk ratios are presented with 95% confidence intervals (CIs).