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NCT00135200 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00135200: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00135200 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135200, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study is for patients with newly diagnosed or relapsed multiple myeloma. The main purpose of this study is to see how their disease responds to consolidation treatment (treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein) called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the side effects which occur with this type of treatment. The investigators will also be looking at how long disease responds to treatment, if it responds at all, and how long patients who have had this treatment survive. Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The antibody is given as an infusion and finds its way to these cells. The radioactive iodine attached to the antibody delivers radiation directly to these cells which works to harm or kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this protein on the surface of their tumor cells. In addition, this protein was found on the surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma cells (less than 5%), these cells are resistant to chemotherapy and are believed to be responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will be used after patients complete a course of chemotherapy and have residual myeloma cells left in their body. The Investigators are hoping that the treatment with Bexxar will decrease and possibly eliminate residual myeloma cells resistant to chemotherapy.
Primary Outcome
The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level. An objective response may be: Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations. Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations. Complete Res
Interventions
- DRUG Iodine I 131 Tositumomab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2005-08 |
| Est. Completion | 2024-09-04 |
| Phase | Phase 2 |
What the finished NCT00135200 record still lists
NCT00135200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Iodine I 131 Tositumomab is the first listed.
NCT00135200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135200 about?
NCT00135200 is a clinical study titled "Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma". This study is for patients with newly diagnosed or relapsed multiple myeloma. The main purpose of this study is to see how their disease responds to consolidation treatment (treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein) called iodine I 131 tositumomab (kno...
What is the current status of trial NCT00135200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2005-08. Estimated completion is 2024-09-04.
What interventions are being tested in trial NCT00135200?
The interventions under investigation include: Iodine I 131 Tositumomab (DRUG).
Who is sponsoring clinical trial NCT00135200?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135200's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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