Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00083577

Purpose

The purpose of this research is to study how helpful thalidomide is in controlling the myeloma disease and to study any side effect resulting from thalidomide.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Thalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients 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: Thalidomide

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma

Secondary Outcome Measures:

To determine toxicities associated with thalidomide in patients with multiple myeloma

Estimated Enrollment:	250
Study Start Date:	February 1998
Estimated Study Completion Date:	May 2005

Detailed Description:

Patients will receive thalidomide in the oral form (by mouth). Then the dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects. After week 7, patients will continue to receive thalidomide as long as there is no toxicity requiring the treatment to be stopped and as long as there is no evidence of rapid tumor growth during the treatment with thalidomide.

Routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. Blood tests will be done once a month for the first six months of receiving thalidomide.

Eligibility

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

Criteria

Inclusion Criteria:

All patients must have a confirmed diagnosis of previously treated, active multiple myeloma
Myeloma protein should be evident from which to evaluate response
Must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug
Patients must have a total white blood cell count of 2,000 K/microliters. Patients may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow involvement with myeloma
Patients must have adequate liver function as demonstrated by a direct bilirubin of < or = 2.0 mg/dL.

Exclusion Criteria:

Patients must not have an active infection requiring parenteral antibiotics
No other concurrent therapy for myeloma is permitted while on Thalidomide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083577

Locations

United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Bart Barlogie, M.D.

UAMS

More Information

Additional Information:

Myeloma Institute for Research & Therapy website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	UARK 98-003
Study First Received:	May 25, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00083577 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arkansas:

Multiple Myeloma
Thalidomide
Anti-Angiogenesis

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Angiogenesis Inhibitors
Immunosuppressive Agents
Multiple Myeloma
Anti-Bacterial Agents
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents

Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Growth Substances
Vascular Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Lymphoproliferative Disorders
Neoplasms, Plasma Cell
Leprostatic Agents

ClinicalTrials.gov processed this record on July 02, 2009