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UARK 99-016, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Multiple Myeloma and Poor Hematopoietic Stem Cell Reserve


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

UARK 99-016, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Multiple Myeloma and Poor Hematopoietic Stem Cell Reserve


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 Multiple myeloma with poor hematopoietic reserve
(platelet count <100,000 OR inability to collect adequate PBSC to support autologous
transplant (4X106 CD34+cells/kg OR WBC <2,000)

- Patients must not be eligible for UARK 98-035

- Patients must be at least 6 weeks beyond previous chemotherapy

- 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

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 refractory myeloma and poor hematopoietic stem cell reserve. Effectiveness will be based on the estimate of the objective response rate (CR + PR).

Principal Investigator

Athanasios Fassas, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Food and Drug Administration

Study ID:

UARK 99-016

NCT ID:

NCT00083408

Start Date:

March 1998

Completion Date:

May 2005

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Pamidronate
  • Thalidomide
  • refractory myeloma
  • bisphosphonates
  • Aredia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

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