A Phase III Study of Armodafinil for the Treatment of Cancer-Related Fatigue for Patients With Multiple Myeloma
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 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Brief Fatigue Index (BFI) Score
Survey measuring fatigue
James Berenson, MD
James R. Berenson MD, Inc.
United States: Institutional Review Board
|Pacific Cancer Medical Center, Inc.||Anaheim, California 92801|
|Michael J. Schlutz, M.D., Inc||Newport Beach, California 92663|
|James R. Berenson, MD, Inc.||West Hollywood, California 90069|