Intervention: Modafinil
Trial phase: Phase 3
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).
Eligibility criteria:
Inclusion Criteria:

The patient has been diagnosed with multiple myeloma based on standard criteria
The patient is diagnosed with cancer-related fatigue based on ICD-10 diagnostic criteria
The patient shows signs of severe fatigue as evidenced by a Brief Fatigue Inventory score of at least 4
The patient is a man or woman aged 18 years or older at the time of informed consent
The patient has given voluntary written informed consent before any study-related procedure is performed which is not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
Women of child bearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
Men must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug
The patient must be willing and able to comply with study restrictions
The patient must have an ECOG performance status not greater than 2
The patient must have a life-expectancy of greater than 3 months

The patient must meet the following laboratory criteria within 14 days of enrollment:

Platelet count greater than 50 x 109/L
Absolute neutrophil count greater than 0.5 x 109/L
Hemoglobin greater than 8 g/dL
AST and ALT not greater than 3.0 x the upper limit of normal (ULN)
Serum bilirubin not greater than 2.0 x ULN
Calculated or measured creatinine clearance of at least 10 mL/minute

Exclusion Criteria:

The patient has been concurrently diagnosed with clinically significant depression
The patient is concurrently enrolled in another investigational study that does not apply to the specific treatment of multiple myeloma
The patient is receiving an investigational agent (non-FDA-approved) for any reason within 28 days of starting treatment on this study
The patient has previously received armodafinil
The patient has received modafinil or a psychostimulant within 14 days of enrollment
The patient has received a blood transfusion within 14 days of enrollment
The patient has impaired cardiac function or clinically significant cardiac diseases
The patient has other concurrent severe and/or uncontrolled medical or psychiatric conditions including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
The patient has known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis B or C is not required
The patient has undergone major surgery within 28 days of enrollment or has not recovered from side effects of such therapy (Kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a patient with a recent history of kyphoplasty with Oncotherapeutics' medical monitor)
The patient has a significant history of noncompliance to medical regimens or unwilling or unable to comply with the instructions given to him or her by the study staff
The patient has a history of skin reactions and/or known sensitivity attributable to compounds of similar chemical or biological composition to modafinil, armodafinil, or the inactive ingredients in armodafinil including lactose monohydrate, starch, microcrystalline cellulose, croscarmellose, sodium, magnesium stearate or povidone
The patient is a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study
The patient is male whose sexual partner is a woman of childbearing potential not using effective birth control