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NCT01207765 · ClinicalTrials.gov registry record · Phase 2
Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma
A Phase 2 study, sponsored by Tufts Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01207765: Clinical Trial Phase 2 study, sponsored by Tufts Medical Center.
NCT01207765 is a Phase 2 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01207765, a Phase 2 study, was terminated before completion, sponsored by Tufts Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The study involves the use of a targeted form of radiation, in addition to standard high dose chemotherapy and stem cell transplant for multiple myeloma. The use of targeted radiation is designed to kill more multiple myeloma cells while avoiding the side effects of standard radiation. This type of targeted radiation (also known as radioimmunotherapy) has been approved by the Food and Drug Administration (FDA) for the treatment of a related disease, lymphoma under the trade name, Zevalin©. Zevalin© has been added to high dose chemotherapy and stem cell transplants for patients with lymphoma and is now being studied in this clinical trial for patients with multiple myeloma. This trial is only available at Tufts Medical Center. The proposed clinical trial will test whether CD20-targeted radio-immunotherapy can be safe and effective when integrated into a standard regimen of myeloablative chemotherapy and autologous stem cell rescue in patients with measurable disease prior to high dose chemotherapy and autologous stem cell transplant for multiple myeloma.
Primary Outcome
Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.
Interventions
- DRUG 90Y Zevalin
- DRUG indium-111-ibritumomab tiuxetan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
Why NCT01207765 stopped before completion
NCT01207765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which 90Y Zevalin is the first listed.
NCT01207765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01207765 about?
NCT01207765 is a clinical study titled "Zevalin for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma". The study involves the use of a targeted form of radiation, in addition to standard high dose chemotherapy and stem cell transplant for multiple myeloma. The use of targeted radiation is designed to kill more multiple myeloma cells while avoiding the side effects of standard radiation. This type of ...
What is the current status of trial NCT01207765?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2008-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01207765?
The interventions under investigation include: 90Y Zevalin (DRUG), indium-111-ibritumomab tiuxetan (DRUG).
Who is sponsoring clinical trial NCT01207765?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01207765's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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