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CompletedNCT00083577Updated Jul 2, 2010

Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

A Phase 2 interventional study of Thalidomide in Multiple Myeloma, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-02.

Sponsored by University of Arkansas · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
250
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research is to study how helpful thalidomide is in controlling the myeloma disease and to study any side effect resulting from thalidomide.

Read the detailed description

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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Thalidomide
  • Anti-Angiogenesis
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 250 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients must not have an active infection requiring parenteral antibiotics
  • No other concurrent therapy for myeloma is permitted while on Thalidomide
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants

Interventions

  • DrugThalidomide
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. To determine toxicities associated with thalidomide in patients with multiple myeloma

07

Study locations

1 site
  • University of Arkansas for Medical Sciences/MIRT
    Little Rock, Arkansas 72205, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00083577
Lead sponsor
University of Arkansas
First posted
May 27, 2004
Start date
Feb 1998
Completion
May 2005
Last update
Jul 2, 2010

Study contacts

Bart Barlogie, M.D.
principal investigator · UAMS
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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