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UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

life time

Safety Issue:

No

Principal Investigator

Bart Barlogie, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Food and Drug Administration

Study ID:

UARK 98-036

NCT ID:

NCT00083382

Start Date:

December 1998

Completion Date:

July 2013

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Thalidomide
  • Pamidronate
  • Aredia
  • Bisphosphonate
  • Anti-Angiogenesis
  • Smoldering/Indolent Myeloma
  • Zometa
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical Sciences/MIRTLittle Rock, Arkansas  72205