Status:
COMPLETED
A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma
Lead Sponsor:
Oncotherapeutics
Collaborating Sponsors:
Cephalon
Conditions:
Fatigue
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, foll...
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 f...
Eligibility Criteria
Inclusion
- 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procedure is performed which is not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01160380
Start Date
June 1 2010
End Date
May 1 2014
Last Update
November 6 2014
Active Locations (3)
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1
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
2
Michael J. Schlutz, M.D., Inc
Newport Beach, California, United States, 92663
3
James R. Berenson, MD, Inc.
West Hollywood, California, United States, 90069