Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
Information source: University of Arkansas
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Pamidronate (Drug); Thalidomide (Drug); Zometa (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Arkansas
Summary
The purpose of this research is to study how helpful the combination of thalidomide and
Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any
side effects.
Clinical Details
Official title: UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with smoldering or indolent myeloma. 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 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.
Locations and Contacts
University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas 72205, United States
Additional Information
Myeloma Institute for Research & Therapy
Starting date: December 1998
Ending date: July 2008
Last updated: December 7, 2007
|
