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UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma


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

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Trial Information

UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma


Patients will receive thalidomide in the oral form (by mouth). Then the dose of thalidomide
will be increased each week until week 7 as long as there are no significant side effects.
After week 7, patients will continue to receive thalidomide as long as there is no toxicity
requiring the treatment to be stopped and as long as there is no evidence of rapid tumor
growth during the treatment with thalidomide.

Routine physical examinations and blood tests will be done to monitor the effect of
treatment and the toxicities encountered, if any, and provide the available treatments for
side effects accordingly. Blood tests will be done once a month for the first six months of
receiving thalidomide.


Inclusion Criteria:



- All patients must have a confirmed diagnosis of previously treated, active multiple
myeloma

- Myeloma protein should be evident from which to evaluate response

- Must be 18 years of age or older. Women of childbearing age and fertile men must use
a medically acceptable means of birth control while on study and for 6 months
thereafter.

- Patients must sign an informed consent to participate in this study, and be fully
aware of the known teratogenic potential of this drug

- Patients must have a total white blood cell count of 2,000 K/microliters. Patients
may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow
involvement with myeloma

- Patients must have adequate liver function as demonstrated by a direct bilirubin of <
or = 2.0 mg/dL.

Exclusion Criteria:

- Patients must not have an active infection requiring parenteral antibiotics

- No other concurrent therapy for myeloma is permitted while on Thalidomide

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 determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma

Principal Investigator

Bart Barlogie, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS

Authority:

United States: Food and Drug Administration

Study ID:

UARK 98-003

NCT ID:

NCT00083577

Start Date:

February 1998

Completion Date:

May 2005

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Thalidomide
  • Anti-Angiogenesis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

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