FDA Approves Lenalidomide as Maintenance Therapy for Patients With Multiple Myeloma Following Autologous Stem Cell Transplant



On February 22, the U.S. Food and Drug Administration (FDA) expanded the existing indication for lenalidomide (Revlimid) 10-mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant.

Clinical Trial Findings

The approval was based on two large studies—CALGB 100104 and IFM 2005-02—including more than 1,000 patients comparing lenalidomide maintenance therapy given until disease progression or unacceptable toxicity after autologous hematopoietic stem cell transplant vs no maintenance. In both studies, the primary efficacy endpoint was progression-free survival.

In the most current progression-free survival analysis, study 1 (CALGB 100104) demonstrated a median progression-free survival of 5.7 years (95% confidence interval [CI] = 4.4–not estimable) vs 1.9 years (95% CI = 1.6–2.5) for no maintenance, a difference of 3.8 years (hazard ratio [HR] = 0.38; 95% CI = 0.28–0.50).

Study 2 (IFM 2005-02) also showed a benefit with a median progression-free survival of 3.9 years (95% CI = 3.3–4.7) vs 2 years (95% CI =1.8­–2.3) for no maintenance, a difference of 1.9 years (HR = 0.53; 95% CI = 0.44–0.64).

A descriptive analysis showed the median overall survival in study 1 was 9.3 years (95% CI = 8.5–not estimable) for patients who received lenalidomide vs 7 years (95% CI = 5.9–8.6) for no maintenance (HR = 0.59; 95% CI = 0.4­–0.78). In study 2, median overall survival was 8.8 years (95% CI = 7.4–not estimable) for patients who received lenalidomide vs 7.3 years (95% CI = 6.7–9.0) for no maintenance (HR = 0.90; 95% CI = 0.72–1.13).

Adverse Events

The most frequently reported adverse reactions in ≥ 20% (lenalidomide arm) across both maintenance studies (study 1, study 2 respectively) were neutropenia (79%, 61%); thrombocytopenia (72%, 24%); leukopenia (23%, 32%); anemia (21%, 9%); upper respiratory tract infection (27%, 11%); bronchitis (5%, 47%); nasopharyngitis (2%, 35%); cough (10%, 27%); gastroenteritis (0%, 23%); diarrhea (55%, 39%); rash (32%, 8%); fatigue (23%, 11%); asthenia (0%, 30%); muscle spasm (0%, 33%); and pyrexia (8%, 21%). The most frequently reported grade 3 or 4 reactions (more than 20% in the lenalidomide arm) included neutropenia, thrombocytopenia, and leukopenia. ■



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