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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 CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, 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 AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
CCOP - OklahomaTulsa, Oklahoma  74136
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
James P. Wilmot Cancer CenterRochester, New York  14642
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Tuft-New England Medical CenterBoston, Massachusetts  02111
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Veterans Affairs Medical Center - GainesvilleGainesville, Florida  32608-1197
Veterans Affairs Medical Center - OmahaOmaha, Nebraska  68105
UF Shands Cancer CenterGainesville, Florida  32610-0277