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Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm

Intervention: dexamethasone (Drug); pamidronate disodium (Drug); thalidomide (Drug); zoledronic acid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
S. V. Rajkumar, MD, Study Chair, Affiliation: Mayo Clinic

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma. PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

Clinical Details

Official title: A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma

Study design: Allocation: Randomized, Primary Purpose: Treatment

Detailed description: OBJECTIVES:

- Compare the response rate of patients with newly diagnosed multiple myeloma treated

with dexamethasone with or without thalidomide.

- Compare the toxicity of these regimens in these patients.

- Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis

grade and on the expression of vascular endothelial growth factor and basic fibroblast growth factor in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone

once daily on days 1-4, 9-12, and 17-20. Patients also receive either pamidronate IV over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening.

- Arm II: Patients receive dexamethasone and pamidronate or zoledronate as in arm I.

Treatment in both arms repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses after the fourth course at the physician's discretion. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 194 patients (97 per treatment arm) will be accrued for this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Newly diagnosed symptomatic multiple myeloma confirmed by the following:

- Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma

cells or biopsy-proven plasmacytosis

- Monoclonal protein (M protein) at least 1. 0 g/dL on serum protein

electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis

- No smoldering myeloma or monoclonal gammopathy of undetermined significance

PATIENT CHARACTERISTICS: Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 50,000/mm^3

- Hemoglobin greater than 7 g/dL

Hepatic:

- Bilirubin no greater than 1. 5 mg/dL

- ALT and AST no greater than 2. 5 times upper limit of normal

Renal:

- Creatinine less than 3 mg/dL

Cardiovascular:

- No prior or concurrent deep venous thrombosis

Other:

- Prior malignancy allowed provided the following criteria are met:

- Received prior treatment with curative intent

- Free of disease for the time period appropriate for cure of the specific cancer

- No grade 2 or greater peripheral neuropathy due to other medical conditions

- No active infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 1 highly effective method and 1 additional method of

contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy:

- No prior biologic therapy for multiple myeloma

- No other concurrent biologic therapy for multiple myeloma

Chemotherapy:

- No prior chemotherapy for multiple myeloma

- No other concurrent chemotherapy for multiple myeloma

Endocrine therapy:

- More than 6 months since prior systemic dexamethasone or glucocorticoids

- No concurrent corticosteroids

Radiotherapy:

- At least 4 weeks since prior palliative, localized radiotherapy

- Concurrent palliative, localized radiotherapy allowed at the physician's discretion

Surgery:

- Not specified

Other:

- No prior systemic therapy for multiple myeloma, except bisphosphonates

- No concurrent anticoagulant therapy for deep vein thrombosis

- No concurrent barbiturates or alcohol (thalidomide arm)

Locations and Contacts

MBCCOP - San Juan, San Juan 00927-5800, Puerto Rico

Veterans Affairs Medical Center - San Juan, San Juan 00927-5800, Puerto Rico

Pretoria Academic Hospitals, Pretoria 0001, South Africa

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304-1290, United States

Stanford University Medical Center, Stanford, California 94305-5408, United States

CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado 80224, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

MBCCOP - Howard University Cancer Center, Washington, District of Columbia 20060, United States

UF Shands Cancer Center, Gainesville, Florida 32610-0277, United States

Veterans Affairs Medical Center - Gainesville, Gainesville, Florida 32608-1197, United States

Veterans Affairs Medical Center - Miami, Miami, Florida 33125, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States

Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida 33612, United States

Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611-3013, United States

Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois 60611-4494, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5289, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana 46202, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa 52722, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

Holden Comprehensive Cancer Center, Iowa City, Iowa 52242-1009, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana 70112, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Tuft-New England Medical Center, Boston, Massachusetts 02111, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417-2399, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Veterans Affairs Medical Center - Omaha, Omaha, Nebraska 68105, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07019, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, United States

Albert Einstein Clinical Cancer Center, Bronx, New York 10461, United States

MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York 10466, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York 11209, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York 10016, United States

Veterans Affairs Medical Center - New York, New York, New York 10010, United States

James P. Wilmot Cancer Center, Rochester, New York 14642, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Toledo Community Hospital, Toledo, Ohio 43623-3456, United States

CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Hahnemann University Hospital, Philadelphia, Pennsylvania 19102-1192, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213-3489, United States

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania 15240-0001, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6307, United States

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee 37212-2637, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-0001, United States

Veterans Affairs Medical Center - Madison, Madison, Wisconsin 53705-2286, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3596, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin 53295, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Related publications:

Ballester O. The emperor's new clothes or the current practice of clinical trials for multiple myeloma in the USA. Cancer Invest. 2008 Jun;26(5):445-7. doi: 10.1080/07357900701874641.

Johnson DC, Corthals S, Ramos C, Hoering A, Cocks K, Dickens NJ, Haessler J, Goldschmidt H, Child JA, Bell SE, Jackson G, Baris D, Rajkumar SV, Davies FE, Durie BG, Crowley J, Sonneveld P, Van Ness B, Morgan GJ. Genetic associations with thalidomide mediated venous thrombotic events in myeloma identified using targeted genotyping. Blood. 2008 Dec 15;112(13):4924-34. doi: 10.1182/blood-2008-02-140434. Epub 2008 Sep 19.

Starting date: April 2002
Last updated: April 2, 2014

Page last updated: August 20, 2015

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