Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083382
First received: May 21, 2004
Last updated: September 15, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


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
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
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 15, 2014
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
Thalidomide
Diphosphonates
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014