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

NCT01160380 | Completed Phase 3 Results

• 1 other identifier: C10953/6270
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Fatigue; Multiple Myeloma

Keywords

cancer related fatigue; fatigue; multiple myeloma; cancer; quality of life

Outcome Measures

Primary Outcomes (4)

• BFI Score

  Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10

  Day 1, Day 28 and Day 56

• Trail Making Test B Score (TMT-B)

  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.

  Day 1, Day 28 and Day 56

• Symbol Digit Modalities Test Score (SDMT)

  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

  Day 1, Day 28 and Day 56

• Digit Span Test Score

  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.

  Day 1, Day 28 and Day 56

Secondary Outcomes (3)

• Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score

  Day 1, Day 28 and Day 56

• Hospital Anxiety and Depression Scale (HADS) Score

  Day 1, Day 28 and Day 56

• Epworth Sleepiness Scale (ESS) Score

  Day 1, Day 28 and Day 56

Study Arms (2)

Armodafinil

EXPERIMENTAL

The patients receive armodafinil for all 56 days of the study.

Drug: armodafinil

Placebo-First

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

armodafinil DRUG

Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

Also known as: Nuvigil

Armodafinil; Placebo-First

Placebo DRUG

Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

Also known as: sugar-pill

Placebo-First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncotherapeutics: lead
• Cephalon: collaborator

Study Sites (3)

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

Michael J. Schlutz, M.D., Inc

Newport Beach, California, 92663, United States

Location

James R. Berenson, MD, Inc.

West Hollywood, California, 90069, United States

Location

MeSH Terms

Conditions

Fatigue; Multiple Myeloma; Neoplasms

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Oncotherapeutics

lthulin@oncotherapeutics.com

310-623-1200

Study Officials

• James Berenson, MD

  James R. Berenson MD, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 12, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: May 1, 2014
• Last Updated: November 6, 2014
• Results First Posted: November 6, 2014

Record last verified: 2014-10

Locations

US (3)