June 15, 2016

Lenalidomide Maintenance After ASCT Improves Overall Survival in Patients With Multiple Myeloma

By Frances Morin

COPENHAGEN, Denmark -- June 15, 2016 -- Patients with multiple myeloma treated with lenalidomide as maintenance therapy following autologous stem cell transplantation (ASCT) show significant improvements in overall survival, according to a study presented here on June 10 at the 21st Congress of the European Hematology Association (EHA).

“This large meta-analysis demonstrates that lenalidomide maintenance significantly prolonged overall survival versus control after autologous stem cell transplant,” said Antonio Palumbo, MD, University of Torino, Torino, Italy.

While lenalidomide has been shown to reduce the risk of disease progression or death in patients with multiple myeloma, studies have not been powered to assess overall survival.

For the current analysis, the researchers identified 17 randomised controlled trials involving the use of lenalidomide in multiple myeloma following ASCT.

Three of the clinical trials met inclusion criteria, including having patient-level data, a control arm, and achieved a database lock for a primary efficacy analysis of patients with newly diagnosed multiple myeloma receiving the treatment following ASCT.

The three studies involved 1,209 patients who were randomised to receive either lenalidomide 10 mg/day on days 1 to 21 (GIMEMA) or 1 to 28 (IFM and CALGB) of 28-day cycles (n = 605), or control (n = 604).

At a median follow-up of 6.6 years, 491 of the patients (41%) had died. Following induction and single ASCT (82%) or tandem (18%), 55% of patients achieved a complete response or very good partial response.

A median overall survival in the lenalidomide group was not reached, whereas the duration was 86 months in the control group (hazard ratio [HR] = 0.74; P =.001).

Five-year, 6-year, and 7-year overall survival rates were longer in the lenalidomide maintenance group compared with the control group (71% vs 66%, 65% vs 58%, and 62% vs 50%, respectively).

Using Fisher’s combination test, the researchers confirmed that lenalidomide was associated with a significant overall survival benefit (P = .001).

The results further showed a benefit of lenalidomide maintenance in patients achieving a partial response or less following ASCT (HR = 0.86) as did those with complete response or very good partial response (HR = 0.70).

“Lenalidomide maintenance is feasible for long-term disease control after autologous stem cell transplant,” Dr. Palumbo said. “The overall survival benefit of lenalidomide maintenance outweighs the risk of developing a second primary malignancy.”

[Presentation title: A Meta-Analysis of Overall Survival in Patients With Multiple Myeloma Treated With Lenalidomide Maintenance After High-Dose Melphalan and Autologous Stem Cell Transplant. Abstract S103]
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