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CompletedNCT00083707Updated Jul 5, 2010

Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom's Macroglobulinemia

A Phase 2 interventional study of Thalidomide in Waldenstrom Macroglobulinemia, 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 2010-07-05.

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

Phase
Phase 2
Study type
Interventional
Enrollment
40
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 disease and to study any side effects from taking thalidomide.

Read the detailed description

Patients will receive thalidomide in the oral form each night before bed. The dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects.

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 to monitor the tumor response.

02

Conditions studied

  • Waldenstrom Macroglobulinemia

Keywords

  • Macroglobulinemia
  • Waldenstrom
  • Thalidomide
03

In context

Waldenstrom Macroglobulinemia

372 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 63 are open to participants now.

This study's enrollment of 40 is close to the median of 40 across 322 interventional studies indexed under Waldenstrom Macroglobulinemia.

Browse Waldenstrom Macroglobulinemia studies →

Lead sponsor

University of Arkansas is the lead sponsor of 398 studies on the registry; 37 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have a confirmed diagnosis of previously treated, active Waldenstrom's Macroglobulinemia
  • Patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine \< or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin \< or = 1.5 mg/dl and transaminases \< or = 4 x ULN
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion criteria

Exclusion Criteria:

  • No other concurrent therapy for WM is permitted while on thalidomide
  • Pregnant or nursing women may not participate. Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. Written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
05

Study design

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

Interventions

06

What researchers measure

Primary outcomes

  1. To determine tumor response, overall and progression free survival following thalidomide therapy in patients with Waldenstrom's Macroglobulinemia (WM)

Secondary outcomes

  1. To determine toxicities associated with thalidomide in patients with Waldenstrom's Macroglobulinemia

07

Study locations

1 site
  • University of Arkansas for Medical Sciences/MIRT
    Little Rock, Arkansas 72205, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00083707
Collaborators
Celgene Corporation
First posted
May 31, 2004
Start date
Jan 1999
Completion
Feb 2003
Last update
Jul 5, 2010

Study contacts

Athanasios Fassas, 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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Studies of the drug tested here: Thalidomide

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