A Multicenter, Single-Arm, Open-Label, Expanded Access Program for Lenalidomide With or Without Dexamethasone in Previously Treated Subjects With Multiple Myeloma
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study
of lenalidomide as monotherapy or in combination with dexamethasone in subjects with
previously treated relapsed or refractory multiple myeloma, with measurable myeloma
paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were
enrolled into the study. Screening procedures took place within 28 days of first dose.
Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily
for 21 days every 28 days.
Subjects had the following options for dexamethasone treatment at the discretion of the
treating physician:
Option A: No dexamethasone.
Option B: Oral pulse dexamethasone administered at a dose of 40 mg daily on Days 1-4, 9-12,
and 17-20 for each 28-day cycle.
Option C: Oral pulse dexamethasone administered at a dose of 20 mg daily on Days 1-4, 9-12,
and 17-20 for each 28-day cycle.
Option D: Oral dexamethasone administered at a dose of 40 mg weekly on Days 1, 8, 15, and 22
for each 28-day cycle for all cycles. Treatment was to be continued as tolerated until
disease progression developed.
Doses of lenalidomide were allowed to be reduced first from 25 mg to 15 mg and then in 5-mg
decrements due to lenalidomide toxicity. Subjects who could not tolerate a daily dose of 5
mg for 21 days every 28 days were discontinued from treatment. At the discretion of the
investigator, doses of dexamethasone were modified due to dexamethasone toxicity. Dose
reduction and discontinuation schemes for dexamethasone varied according to the treatment
option administered.
Study visits occurred every 2 weeks for the first 3 cycles of therapy and then every 4 weeks
after the third cycle until disease progression was documented, study drug was discontinued
for another reason, or lenalidomide became commercially available for this indication.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.
Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Median time-on-study=18.3 weeks
Yes
Robert Knight, MD
Study Director
Celgene Corporation
United States: Food and Drug Administration
CC-5013-MM-016
NCT00179647
September 2005
April 2009
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Swedish Cancer Institute | Seattle, Washington 98104 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
Carolinas Hematology-Oncology Associates | Charlotte, North Carolina 28203 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania 15224 |
Nevada Cancer Center | Las Vegas, Nevada 89109 |
Rush Cancer Institute | Chicago, Illinois 60612 |
Kaiser Permanente Medical Group | Los Angeles, California 90027 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
St. Vincent's Comprehensive Cancer Center | New York, New York 10011 |
SUNY Upstate Medical University | Syracuse, New York 13210 |
Scripps Cancer Center | La Jolla, California 92037 |
Deaconess Billings Clinic | Billings, Montana 59107-5100 |
Emory University | Atlanta, Georgia 30322 |
Kaiser Permanente Medical Center | Vallejo, California 94589 |
H Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Mayo Clinic | Scottsdale, Arizona |
University of Texas Southwestern Medical Center | Dallas, Texas |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Avera Research Institute | Sioux Falls, South Dakota 57105 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Rocky Mountain Cancer Center-Midtown | Denver, Colorado 80218 |
InterMountain Hematology/Oncology | Salt Lake City, Utah 84122 |
Yale University School Of Medicine | New Haven, Connecticut 06520 |
Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
Charleston Hematology/Oncology P.A. | Charleston, South Carolina 29403 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Alta Bates Cancer Center | Berkeley, California 94704 |
The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Hematology Oncology, PC | Stamford, Connecticut 06902 |
Oncology Alliance | Milwaukee, Wisconsin 53215 |
Cedar Sinai Medical CenterDept of Medicine | Los Angeles, California 90048 |
University of ColoradoHealth Science Center | Aurora, Colorado 80045-0510 |
Delaware Clinical & Laboratory Physicians, PA | Newark, Delaware 19713 |
University of Miami Medical School | Miami, Florida 33136 |
Gulf Coast Oncology | St. Petersburg, Florida 33705 |
The Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Northwestern University Med CtrDivision of Hem/Onc | Chicago, Illinois 60611-2927 |
Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research Institute | Indianapolis, Indiana 46202-5254 |
University of Maryland Medical Center Greenbaum Cancer Ctr | Baltimore, Maryland 21201-1595 |
Jackson Oncology Associates | Jackson, Mississippi 39202 |
Dartmouth Hitchcock Medical Center-Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
New York Medical Center, MBCCOP | Bronx, New York 10466 |
SUNY Health Science Center - Brooklyn | Brooklyn, New York 11203 |
North Shore Hematology/Oncology Associates, PC | East Setauket, New York 11733 |
NY Presbyterian Hospital/Weill Medical College-Cornell University | New York, New York 10021 |
Mid Ohio Oncology & Hematology, Inc. | Columbus, Ohio 43215 |
Kaiser Permanente Northwest RegionCenter for Health Research | Portland, Oregon 97227 |
South Carolina Oncology Assoc | Columbia, South Carolina 29210 |
Medical College of Virginis, North Hospital | Richmond, Virginia 23298 |
Gunderson Clinic | LaCrosse, Wisconsin 54601 |