Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

This study is ongoing, but not recruiting participants.

First Received: April 4, 2003 Last Updated: September 22, 2009 History of Changes

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00057564

Purpose

Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Thalidomide and Dexamethasone Drug: Dexamethasone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Parallel-Group, Placebo Controlled, Randomized, Double-Blind Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Thalidomide Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Compare the efficacy of combination thalidomide and dexamethasone treatments [ Time Frame: Years ] [ Designated as safety issue: No ]

Enrollment:	470
Study Start Date:	February 2003
Estimated Study Completion Date:	December 2011
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Thalidomide & Dexamethasone	Drug: Thalidomide and Dexamethasone 50mg thalidomide
B: Placebo Comparator Dexamethasone and placebo	Drug: Dexamethasone 40mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active Multiple Myeloma Stage II or III Durie Salmon
Measurable levels of myeloma paraprotein in serum or urine
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 greater than or equal to grade 2 of the NCI CTC.
Prior history of malignancy unless subject has been free of disease for greater than or equal to 5 years
Lab abnormality: Absolute neutrophil count less than 1,000 cells/mm cubed
Lab abnormality: Platelet count less than 50,000 mm cubed
Lab abnormality: Serum creatinine greater than 3.0 mg/dL
Lab abnormality: Serum SGOT/AST or SGPT/ALT greater than 3 times the upper limit
Lab abnormality: Serum total bilirubin greater than 2.0 mg/dL.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057564

Show 99 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Robert Knight, MD

Celgene Corporation

More Information

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Rajkumar SV, Rosiñol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Bladé J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. Epub 2008 Mar 24.

Responsible Party:	Celgene Corporation ( Robert Knight MD, VP Oncology/Hematology )
Study ID Numbers:	THAL-MM-003
Study First Received:	April 4, 2003
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00057564 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Newly Diagnosed Multiple Myeloma
Multiple Myeloma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Immunologic Factors
Thalidomide
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders

Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances
Gastrointestinal Agents
Vascular Diseases
Angiogenesis Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 30, 2009