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Completed

NCT Number: NCT00083408

Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pamidronate

Drug

thalidomide

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study 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

Important dates

Study start
1998
Study completion
2005
First posted
May 25, 2004
Registry last updated
Jul 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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