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

NCT00033332 | Completed Phase 3

• 3 other identifiers: CDR0000069274U10CA021115E-E1A00
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 78

Brief 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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Interventions

dexamethasone DRUG

pamidronate disodium DRUG

thalidomide DRUG

zoledronic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (78)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, 94304-1290, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

CCOP - Colorado Cancer Research Program, Inc.

Denver, Colorado, 80224, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Veterans Affairs Medical Center - Gainesville

Gainesville, Florida, 32608-1197, United States

Location

UF Shands Cancer Center

Gainesville, Florida, 32610-0277, United States

Location

Veterans Affairs Medical Center - Miami

Miami, Florida, 33125, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611-4494, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, 46202, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

MBCCOP - LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Tuft-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417-2399, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Veterans Affairs Medical Center - Omaha

Omaha, Nebraska, 68105, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07019, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Veterans Affairs Medical Center - Brooklyn

Brooklyn, New York, 11209, United States

Location

Veterans Affairs Medical Center - New York

New York, New York, 10010, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102-1192, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Veterans Affairs Medical Center - Pittsburgh

Pittsburgh, Pennsylvania, 15240-0001, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

Nashville, Tennessee, 37212-2637, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6307, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705-2286, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3596, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

MBCCOP - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Veterans Affairs Medical Center - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Pretoria Academic Hospitals

Pretoria, 0001, South Africa

Location

Related Publications (5)

• 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.

  PMID: 18568765 BACKGROUND

• 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.

  PMID: 18805967 BACKGROUND

• Kumar S, Greipp PR, Haug JL, et al.: Correlation of bone marrow angiogenesis and response to thalidomide dexamethasone in multiple myeloma. [Abstract] J Clin Oncol 24 (Suppl 18): A-7621, 451s, 2006.

  RESULT

• Rajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR; Eastern Cooperative Oncology Group. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2006 Jan 20;24(3):431-6. doi: 10.1200/JCO.2005.03.0221. Epub 2005 Dec 19.

  PMID: 16365178 RESULT

• Greipp PR. Eastern Cooperative Oncology Group E1A00: phase III randomized study of dexamethasone with or without thalidomide in patients with newly diagnosed multiple myeloma. Clin Adv Hematol Oncol. 2003 Mar;1(3):188-9. No abstract available.

  PMID: 16224404 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Dexamethasone; Pamidronate; Thalidomide; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles

Study Officials

• S. V. Rajkumar, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: March 1, 2006
• Study Completion: June 1, 2006
• Last Updated: April 4, 2014

Record last verified: 2005-11

Locations

US (75); ZA (1); PR (2)