Schmitt, T., Goldschmidt, H., Neben, K., Freiberger, A., Husing, J., Gronkowski, M., . . . Egerer, G. (2014). Aprepitant, granisetron, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting after high-dose melphalan in autologous transplantation for multiple myeloma: Results of a randomized, placebo-controlled phase III trial. Journal of Clinical Oncology, 32, 3413–3420. 

To evaluate the efficacy of aprepitant plus a standard antiemetic regimen (granisetron plus dexamethasone) in preventing CINV for patients with multiple myeloma receiving high-dose chemotherapy and autologous stem-cell transplantation (ASCT)

Patients randomly were assigned to receive either aprepitant (125 mg orally on day 1 and 80 mg orally on days 2–4) plus granisetron (2 mg orally on days 1–4) and dexamethasone (4 mg orally on day 1 and 2 mg orally on days 2–3) or a placebo plus granisetron (2 mg orally on days 1–4) and dexamethasone (8 mg orally on day 1 and 4 mg orally on days 2–3). High-dose chemotherapy (melphalan 100 mg/m²) was administered on days 1–2, and ASCTs were performed on day 4.

• N = 362
• MEAN AGE = 58.1 years
• MALES: 230 (64%), FEMALES: 132 (36%)
• KEY DISEASE CHARACTERISTICS: Multiple myeloma
• OTHER KEY SAMPLE CHARACTERISTICS: High-dose chemotherapy; receiving ASCT

• SITE: Single site    
• SETTING TYPE: Inpatient  
• LOCATION: Large university hospital in Germany

• PHASE OF CARE: Active antitumor treatment

Prospective, placebo-controlled, randomized, double-blinded, parallel-group, single-center study

• Functional Living Index–Emesis (FLI-E) questionnaire to record quality of life
• Daily diary with a 100 mm Visual Analog Scale (VAS) to record episodes and severity of nausea and vomiting

Patients receiving aprepitant plus standard antiemetic therapy were significantly more likely to achieve complete response (no emesis and no rescue therapy within 120 hours of melphalan administration) (p = 0.0042), were significantly more likely to be without major nausea (p = 0.026) and emesis (p = 0.0036) within 120 hours of melphalan administration, and had a higher quality of life (p < 0.001) compared to the placebo plus standard antiemetic therapy group.

The addition of aprepitant to standard antiemetic therapy resulted in significantly less CINV and a positive effect on quality of life.

The addition of aprepitant to standard antiemetic therapy not only reduced CINV but also improved quality of life for patients receiving ASCT.