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Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
This study is ongoing, but not recruiting participants.
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00083382
  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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide Zoledronic acid Bismuth subsalicylate Dioctyl sulfosuccinic acid Docusate calcium Kaopectate Lactulose Pamidronate disodium Amidronate Magnesium oxide Bisacodyl Bisacodyl tannex Magnesium hydroxide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2008
Intervention Details:
    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.

    Drug: Thalidomide
    reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)
    Drug: Zometa

    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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083382

Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  More Information

Myeloma Institute for Research & Therapy  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Responsible Party: University_of_Arkansas ( Naveen Kumar, CRA )
Study ID Numbers: UARK 98-036
Study First Received: May 21, 2004
Last Updated: December 7, 2007
ClinicalTrials.gov Identifier: NCT00083382  
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

Study placed in the following topic categories:
Immunoproliferative Disorders
Zoledronic acid
Magnesium Oxide
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Magnesium Hydroxide
Vascular Diseases
Paraproteinemias
Bisacodyl
Hemostatic Disorders
Bismuth subsalicylate
Multiple Myeloma
Diphosphonates
Hemorrhagic Disorders
Multiple myeloma
Pamidronate
Lymphoproliferative Disorders
Lactulose
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 15, 2009