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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

S. V. Rajkumar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069274

NCT ID:

NCT00033332

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Mayo Clinic Cancer Center Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
CCOP - Duluth Duluth, Minnesota  55805
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Medical College of Wisconsin Milwaukee, Wisconsin  53226
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
CCOP - Scott and White Hospital Temple, Texas  76508
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
CCOP - Oklahoma Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
James P. Wilmot Cancer Center Rochester, New York  14642
City of Hope Comprehensive Cancer Center Duarte, California  91010
Tuft-New England Medical Center Boston, Massachusetts  02111
Albert Einstein Clinical Cancer Center Bronx, New York  10461
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
MBCCOP-Our Lady of Mercy Cancer Center Bronx, New York  10466
Veterans Affairs Medical Center - Gainesville Gainesville, Florida  32608-1197
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105
UF Shands Cancer Center Gainesville, Florida  32610-0277