Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Pamidronate Drug: Thalidomide Drug: Zometa |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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). [ Time Frame: life time ] [ Designated as safety issue: No ]
- To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival. [ Time Frame: life time ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 1998 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
-
Drug: Pamidronate
All patients will receive pamidronate at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles.
Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
All patients will receive zometa at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles.
Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences/MIRT | |
| Little Rock, Arkansas, United States, 72205 | |
| Principal Investigator: | Bart Barlogie, MD, PhD | University of Arkansas |
More Information
Additional Information:
No publications provided by University of Arkansas
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00083382 History of Changes |
| Other Study ID Numbers: | UARK 98-036 |
| Study First Received: | May 21, 2004 |
| Last Updated: | September 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
Myeloma Thalidomide Pamidronate Aredia |
Bisphosphonate Anti-Angiogenesis Smoldering/Indolent Myeloma Zometa |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Pamidronate |
Zoledronic acid Diphosphonates Thalidomide Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013