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NCT00492050 · ClinicalTrials.gov registry record · Phase 2
Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia
A Phase 2 study of Waldenstrom's Macroglobulinemia, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT00492050: Active Phase 2 study of Waldenstrom's Macroglobulinemia, sponsored by M.D. Anderson Cancer Center.
NCT00492050 is a Phase 2 study of Waldenstrom's Macroglobulinemia that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 46 participants, below the 154-participant average among 5 other Waldenstrom's Macroglobulinemia trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00492050, a Phase 2 study of Waldenstrom's Macroglobulinemia, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given with rituximab can help to control WM. This drug combination will allow researchers to collect your stem cells in case it is possible to transplant the stem cells as treatment if your WM gets worse. Researchers will also look at the safety and tolerability of this drug combination followed by treatment with other drug combinations.
Primary Outcome
Partial response (PR) defined as at least \> 50 % reduction of serum monoclonal IgM concentration determined by protein electrophoresis, \> 50% decrease in adenopathy / organomegaly on physical examination or on CT scan, and no new symptoms or signs of active disease. Complete response (CR) defined as a disappearance of serum and urine monoclonal protein determined by immunofixation, absence of malignant cells in bone marrow determined by histologic evaluation, resolution of adenopathy/organomeg
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Valacyclovir
- DRUG Bortezomib
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2006-08-02 |
| Est. Completion | 2026-06-28 |
| Phase | Phase 2 |
What the registry record for NCT00492050 still lists
NCT00492050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 154-participant average among 5 other Waldenstrom's Macroglobulinemia trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Waldenstrom's Macroglobulinemia appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT00492050 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00492050 about?
NCT00492050 is a clinical study titled "Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia". The main goal of this clinical research study is to learn if Velcade ® (bortezomib) given with rituximab can help to control WM. This drug combination will allow researchers to collect your stem cells in case it is possible to transplant the stem cells as treatment if your WM gets worse. Researchers...
What is the current status of trial NCT00492050?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2006-08-02. Estimated completion is 2026-06-28.
What conditions does trial NCT00492050 study?
This clinical trial studies the following conditions: Waldenstrom's Macroglobulinemia.
What interventions are being tested in trial NCT00492050?
The interventions under investigation include: Rituximab (DRUG), Valacyclovir (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT00492050?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00492050 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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