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Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Pamidronate (Drug); Thalidomide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Arkansas

Official(s) and/or principal investigator(s):
Athanasios Fassas, M.D., Principal Investigator, Affiliation: University of Arkansas

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Myeloma Institute for Research & Therapy website

Starting date: March 1998
Last updated: July 1, 2010

Page last updated: August 20, 2015

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