A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma
Condition: Fatigue; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Fatigue
Intervention: armodafinil; Placebo
Intervention description: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.; Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer related fatigue; fatigue; multiple myeloma; cancer; quality of life

Summary:

      The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of
      cancer-related fatigue in adult patients with multiple myeloma. The study consists of a
      screening period, followed by a 56-day treatment phase, and a final assessment to occur 28
      days after the end of the last treatment.
    

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             understanding that consent may be withdrawn by the patient at any time without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