Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00083408

Purpose

The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate is in controlling multiple myeloma and to study any side effects that may be experienced.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Pamidronate Drug: Thalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	UARK 99-016, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Multiple Myeloma and Poor Hematopoietic Stem Cell Reserve

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Thalidomide

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with refractory myeloma and poor hematopoietic stem cell reserve. Effectiveness will be based on the estimate of the objective response rate (CR + PR).

Secondary Outcome Measures:

To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival.

Estimated Enrollment:	20
Study Start Date:	March 1998
Estimated Study Completion Date:	May 2005

Detailed Description:

Recently, laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size, tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called “anti-angiogenesis”. It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.

Eligibility

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

Criteria

Inclusion Criteria:

Patients must have a diagnosis of Multiple myeloma with poor hematopoietic reserve (platelet count <100,000 OR inability to collect adequate PBSC to support autologous transplant (4X106 CD34+cells/kg OR WBC <2,000)
Patients must not be eligible for UARK 98-035
Patients must be at least 6 weeks beyond previous chemotherapy
All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines

Exclusion Criteria:

Prior bisphosphonate therapy within 30 days prior to study entry
Serum creatinine > 5 mg/dl, ascites, or serum direct bilirubin > 2.5 mg/dl
Prior plicamycin or calcitonin within 2 weeks of study entry
Severe cardiac disease, unstable thyroid disease, or epilepsy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083408

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:

Athanasios Fassas, M.D.

University of Arkansas

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	UARK 99-016
Study First Received:	May 24, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00083408 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arkansas:

Multiple Myeloma
Pamidronate
Thalidomide

refractory myeloma
bisphosphonates
Aredia

Study placed in the following topic categories:

Anti-Infective Agents
Immunoproliferative Disorders
Immunologic Factors
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Bone Density Conservation Agents
Paraproteinemias

Hemostatic Disorders
Angiogenesis Inhibitors
Immunosuppressive Agents
Multiple Myeloma
Anti-Bacterial Agents
Diphosphonates
Hemorrhagic Disorders
Pamidronate
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
Bone Density Conservation Agents
Hemostatic Disorders
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Pamidronate
Cardiovascular Diseases
Growth Inhibitors

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

ClinicalTrials.gov processed this record on September 03, 2009