UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma
Pamidronate
+ Thalidomide
+ Zometa
Blood Protein Disorders+11
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: December 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.83 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients must have a diagnosis of Smoldering or Indolent myeloma * 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. * Prior radiation therapy to \> 20% of the skeleton.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location