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A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01160380
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Fatigue Multiple Myeloma Drug: armodafinil Drug: Placebo Phase 3

Detailed Description:

This is a Phase III, multi-center, double-blind, randomized, placebo-controlled, crossover study to evaluate the efficacy of armodafinil at a dosage of 150 mg/day for the treatment of cancer-related fatigue (CRF) 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.

The screening period will occur within 14 days before baseline, where "baseline" refers to day 1 when assessments will be made before drug administration. During this period, a medical history will be obtained along with a complete physical examination including vital sign measurements and Eastern Cooperative Oncology Group (ECOG) performance status. Clinical laboratory tests including hematology, clinical chemistry (blood urea nitrogen [BUN], serum creatinine, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), electrolytes (potassium, sodium, chloride and calcium), random glucose, total protein, albumin, and urinalysis will also be performed during the screening period as well as serum pregnancy tests for women of childbearing potential.

During the screening period, patients will also be assessed for the presence of cancer-related fatigue using the International Classification for Disease Tenth Edition (ICD-10) diagnostic criteria and the Brief Fatigue Inventory (BFI). Only those patients showing evidence of cancer-related fatigue will be enrolled in the study. The criteria for inclusion for any given patient consist of meeting the International Classification for Disease Tenth Edition (ICD-10) criteria for cancer-related fatigue and a score ≥ 4 on the BFI. ICD-10 CRF classification will be established using a standard interview guide.

Patients eligible for the study will be randomized to either receive armodafinil at an initial fixed dosage of 150 mg/day (Group A) or a placebo (Group B) during the first 28 days of the treatment phase. On day 29, patients randomized to receive placebo will then cross over to receive armodafinil at a dosage of 150 mg/day until day 56. Group A patients randomized to receive armodafinil will continue their current treatment with the drug until day 56. The duration of the treatment phase is 56 days.

Assessments for CRF will be conducted on day 1 (baseline) prior to drug treatment, and after drug administration on days 15, 28, 43, and 56. These assessments will be conducted as verbal interviews, paper-and-pencil surveys, paper-and-pencil tests, and electronic tests as appropriate per assessment.

During the treatment phase, each patient will also have clinical laboratory tests performed on days 1, 15, 28, 43 and 56 to monitor for potential toxicity. Additional procedures performed at these visits will include monitoring for adverse events, review of concomitant medications and other support therapies (e.g., growth factors and transfusion), ECOG performance status, vital signs measurements, and physical examinations.

Twenty-eight days after the last dose of study drug, patients are to complete a final assessment (herein referred to as the end-of-treatment visit). Procedures to be conducted at this visit include measurement of vital signs, a complete physical examination, assessment of adverse events, a review of concomitant medications, assessment of ECOG performance status, hematology and clinical chemistry laboratory tests including electrolytes, total protein and albumin. Patients who withdraw from the study before the completion of the 56 day cycle will still have all end-of-treatment assessments performed 28 days after their last dose of study drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Phase III Study of Armodafinil for the Treatment of Cancer-Related Fatigue for Patients With Multiple Myeloma
Study Start Date : June 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Armodafinil

Arm Intervention/treatment
Experimental: Armodafinil
The patients receive armodafinil for all 56 days of the study.
Drug: armodafinil
Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Other Name: Nuvigil

Placebo Comparator: Placebo-First
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Drug: armodafinil
Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Other Name: Nuvigil

Drug: Placebo
Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
Other Name: sugar-pill

Primary Outcome Measures :
  1. BFI Score [ Time Frame: Day 1, Day 28 and Day 56 ]
    Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10

  2. Trail Making Test B Score (TMT-B) [ Time Frame: Day 1, Day 28 and Day 56 ]

    Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.

    The test evaluates the time to correctly order letters and numbers; low times = better performance.

  3. Symbol Digit Modalities Test Score (SDMT) [ Time Frame: Day 1, Day 28 and Day 56 ]
    Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance

  4. Digit Span Test Score [ Time Frame: Day 1, Day 28 and Day 56 ]
    Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.

Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score [ Time Frame: Day 1, Day 28 and Day 56 ]
    Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).

  2. Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Day 1, Day 28 and Day 56 ]
    Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.

  3. Epworth Sleepiness Scale (ESS) Score [ Time Frame: Day 1, Day 28 and Day 56 ]
    Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01160380

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United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
Michael J. Schlutz, M.D., Inc
Newport Beach, California, United States, 92663
James R. Berenson, MD, Inc.
West Hollywood, California, United States, 90069
Sponsors and Collaborators
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Principal Investigator: James Berenson, MD James R. Berenson MD, Inc.

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Responsible Party: Oncotherapeutics Identifier: NCT01160380    
Other Study ID Numbers: C10953/6270
First Posted: July 12, 2010    Key Record Dates
Results First Posted: November 6, 2014
Last Update Posted: November 6, 2014
Last Verified: October 2014
Keywords provided by Oncotherapeutics:
cancer related fatigue
multiple myeloma
quality of life
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action