Back to resultsCombination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pamidronate
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Pamidronate, Thalidomide, refractory myeloma, bisphosphonates, Aredia
Eligibility 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
Sites / Locations
- University of Arkansas for Medical Sciences/MIRT
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00083408
Brief Title
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Arkansas
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Pamidronate, Thalidomide, refractory myeloma, bisphosphonates, Aredia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pamidronate
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanasios Fassas, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences/MIRT
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Links:
URL
http://myeloma.uams.edu
Description
Myeloma Institute for Research & Therapy website
Learn more about this trial
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
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