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01.06.2015 | Original Article | Ausgabe 6/2015

Supportive Care in Cancer 6/2015

A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma

Supportive Care in Cancer > Ausgabe 6/2015
James R. Berenson, Ori Yellin, Hesaraghatta K. Shamasunder, Chien-Shing Chen, Veena Charu, Thomas B. Woliver, Shamel Sanani, Michael Schlutz, Youram Nassir, Regina A. Swift, Claudia Andreu-Vieyra, Robert Vescio
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1007/​s00520-014-2486-7) contains supplementary material, which is available to authorized users.

Author Contributions

JRB designed the study, analyzed data, wrote the paper, and approved its final version. OY helped design the study. HKS, C-SC, VC, TBW, SS, and MS enrolled patients and edited the paper. YN and RAS performed research and edited the paper. CA-V performed the statistical analysis, wrote, and edited the paper, and RV monitored the trial and edited the paper.



Fatigue is a common problem among multiple myeloma (MM) patients. Armodafinil is a drug known to promote wakefulness, which is related to modafinil, a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents. We investigated whether armodafinil could reduce cancer-related fatigue in MM patients.


This double-blind, placebo-controlled phase 3 trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue. Patients were randomized to one of two arms: treatment-only, with armodafinil given at 150 mg/daily for 56 days, or placebo-first, with placebo given on days 1–28, followed by armodafinil administered at 150 mg daily on days 29–56. Fatigue was measured on days 1 (pre-dose: baseline), 15, 28, 43, and 56 using seven separate assessments, including four patient-reported outcomes of fatigue and related quality of life measures, as well as three objective measures of cognitive function.


Overall toxicities were similar between treatment groups. No significant differences were observed between the placebo-first and the treatment-only arms after 28 days. Treatment with armodafinil for 28 additional days did not produce responses. Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day 28 compared to baseline. Placebo-first patients improved on eight additional measures (one patient-reported measure, six subscales, and one objective task), suggesting a strong placebo effect in this patient population.


Evaluation and treatment of cancer-related fatigue continues to be challenging; a clear definition of this symptom and better assessment tools are needed.

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Supplementary Table 1 (DOCX 26 kb)
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