Dexamethasone Liquid |
Decadron Liquid; Hexadrol Liquid |
Clinical Trial: Dexamethasone With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Multiple Myeloma
This study is currently recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with newly diagnosed stage I, stage II, or stage III multiple myeloma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma | Drug: dexamethasone Drug: lenalidomide Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: endocrine therapy Procedure: growth factor antagonist therapy Procedure: hormone therapy Procedure: steroid therapy | Phase III |
MedlinePlus related topics: Multiple Myeloma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Dexamethasone With or Without Lenalidomide in Patients With Newly Diagnosed Stage I, II, or III Multiple Myeloma
OBJECTIVES:
- Compare the progression-free survival of patients with newly diagnosed stage I, II, or III multiple myeloma treated with dexamethasone with or without lenalidomide.
- Compare the overall response rate in patients treated with these regimens.
- Compare the major response rate (indicated by greater than 75% decrease in M-protein) in patients treated with these regimens.
- Compare the overall survival and time to best response in patients treated with these regimens.
- Compare the toxicity profile of these regimens, including thrombotic complications, in these patients.
- Compare the effect of these regimens on gene expression and proteomic analysis in these patients.
OUTLINE: This is a randomized, double-blind, crossover, multicenter study. Patients are stratified according to disease stage by the International Staging System (I vs II vs III) and Zubrod performance status (0-1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.
Arm I:
- Induction therapy: Patients receive oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
- Maintenance therapy: Patients receive oral DM on days 1-4 and 14-17 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II:
- Patients receive DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Patients with responding or stable disease proceed to maintenance therapy. Patients with disease progression during induction therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy receive unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.
- Patients receive oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance. Patients with disease progression during maintenance therapy cross over and receive unblinded treatment with DM and lenalidomide as in arm I induction. Patients with responding or stable disease after unblinded induction therapy proceed to unblinded maintenance therapy with DM and lenalidomide as in arm I maintenance.
Patients are followed for up to 5 years.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed multiple myeloma
- Stage I, II, or III disease by the International Staging System
- Measurable M-protein as defined by 1 of the following:
- Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or immunoelectrophoresis
- Urinary M-protein excretion at least 200 mg/24 hours
- No nonsecretory multiple myeloma
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- Zubrod 0-3* NOTE: *Zubrod 3 allowed only if multiple myeloma is the central cause of disability
Life expectancy
- Not specified
Hematopoietic
- Platelet count at least 80,000/mm^3*
- Absolute neutrophil count at least 1,000/mm^3*
- Hemoglobin at least 9 g/dL* (epoetin alfa or transfusion allowed) NOTE: *Unless due to greater than 50% marrow involvement by myeloma on biopsy
Hepatic
- AST/ALT no greater than 3 times upper limit of normal* NOTE: *Values outside of this range are allowed at the investigator's discretion
Renal
- Creatinine no greater than 2.5 mg/dL* NOTE: *Values outside of this range are allowed at the investigator's discretion
Cardiovascular
- No New York Heart Association class III or IV heart failure
- No myocardial infarction within the past 6 months
- No poorly controlled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use 1 highly effective method and 1 additional method of contraception
- Male patients must use effective barrier contraception during and for 4 weeks after study participation
- No uncontrolled active infection requiring IV antibiotics
- No poorly controlled diabetes mellitus that would preclude ability to take oral glucocorticoids
- No other serious medical condition that would preclude study participation
- No psychiatric illness that would preclude study participation
- No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy
- No prior interferon or thalidomide
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior high-dose dexamethasone allowed provided duration of administration was no more than 4 days
Radiotherapy
- Prior localized radiotherapy allowed provided it was not to the sole site of evaluable disease
Surgery
- Not specified
Other
- No prior treatment for clinically significant ventricular cardiac arrhythmias
- Concurrent bisphosphonates allowed
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base, California, 94535, United States; Recruiting
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, 90073, United States; Recruiting
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Florida
Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, 30905-5650, United States; Recruiting
Hawaii
Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Tripler Army Medical Center, Honolulu, Hawaii, 96859-5000, United States; Recruiting
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Massachusetts
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, 02130, United States; Recruiting
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Mississippi
Keesler Medical Center - Keesler Air Force Base, Keesler AFB, Mississippi, 39534-2576, United States; Recruiting
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, 39531-2410, United States; Recruiting
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, 64128, United States; Recruiting
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Veterans Affairs Medical Center - Albany, Albany, New York, 12208, United States; Recruiting
Western New York Urology Associates, Buffalo, New York, 14220, United States; Recruiting
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Tennessee
Danville Radiation Therapy Center, Memphis, Tennessee, 38104, United States; Recruiting
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
Southwest Cancer and Research Center at University Medical Center, Lubbock, Texas, 79415-3364, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Vermont
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, 05401, United States; Recruiting
Virginia
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, 23510-1115, United States; Recruiting
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Madigan Army Medical Center, Tacoma, Washington, 98431-5000, United States; Recruiting
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, 98104, United States; Recruiting
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
Canada, British Columbia
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada; Recruiting
Jeffrey A. Zonder, MD, Study Chair, Barbara Ann Karmanos Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: January 2005
Last Updated: April 4, 2005
Record first received: July 8, 2003
ClinicalTrials.gov Identifier: NCT00064038
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Decadron Liquid (Drug Digest)
- Dexamethasone Liquid (Drug Digest)

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