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A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma


Inclusion Criteria:



- Active Multiple Myeloma Stage II or III Durie Salmon

- Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g
excreted in a 24-hour collection sample)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2

- Women of child bearing potential must agree to abstain for heterosexual intercourse
or use 2 methods of contraception, one effective (for example hormonal or tubal
ligation) and one barrier (for example latex condom, diaphragm)

- Males must agree to use barrier contraception (latex condoms) when engaging in
reproductive activity

Exclusion Criteria:

- Pregnant or lactating females

- Peripheral neuropathy ≥ to grade 2 of the NCI CTC.

- Prior history of malignancy unless subject has been free of disease for ≥ 3 years

- Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)

- Lab abnormality: Platelet count <50,000/mm^3 (50.0 x 10^9/L)

- Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L)

- Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate
aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine
transaminase (ALT) >3.0 x upper limit of normal (ULN)

- Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to tumor progression (TTP)

Outcome Description:

Time to tumor progression (TTP)

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

THAL-MM-003

NCT ID:

NCT00057564

Start Date:

February 2003

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • Newly Diagnosed Multiple Myeloma
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UCLA School of MedicineLos Angeles, California  900121973
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Medical College of WisconsinMilwaukee, Wisconsin  53226
Mayo ClinicJacksonville, Florida  32224
Arizona Clinical Research CenterTucson, Arizona  85712
Medical College of GeorgiaAugusta, Georgia  30912
University of PittsburghPittsburgh, Pennsylvania  15261
SUNY Upstate Medical UniversitySyracuse, New York  13210
Oncology Hematology Group of South FloridaMiami, Florida  33176
University of MiamiMiami, Florida  33136
Clinical Research Consultants, Inc.Hoover, Alabama  35216
Rush Cancer Institute Section of HematologyChicago, Illinois  60612-3824
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
South Carolina Oncology GroupWest Columbia, South Carolina  29169
James BerensonWest Hollywood, California  90069
Melbourne Internal Medicine Associates OncologyMelbourne, Florida  32901-3182
Jackson Memorial Hospital and ClinicsMiami, Florida  33136
University of Miami Miller School/Jackson Memorial HospitalMiami, Florida  33136
Southern Illinois Hematology /OncologyCentralia, Illinois  62801
University of Iowa Hospital of ClinicIowa City, Iowa  52242
Ocshner Clinic FoundationNew Orleans, Louisiana  70121
Hackensack University HospitalHackensack, New Jersey  07601
Cleveland Clinic- Taussig Cancer CenterCleveland, Ohio  44195
The Family Centre, PLLCCollierville, Tennessee  38017
East Tennessee Oncology/Hematology AssociatesKnoxville, Tennessee  37920