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NCT01470196 · ClinicalTrials.gov registry record · Phase 2
Carfilzomib, Rituximab and Dexamethasone in Waldenstrom's Macroglobulinemia
A Phase 2 study of Waldenstrom's Macroglobulinemia, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01470196: Completed Phase 2 study of Waldenstrom's Macroglobulinemia, sponsored by Dana-Farber Cancer Institute.
NCT01470196 is a Phase 2 study of Waldenstrom's Macroglobulinemia that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 31 participants, below the 157-participant average among 5 other Waldenstrom's Macroglobulinemia trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01470196, a Phase 2 study of Waldenstrom's Macroglobulinemia, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within the cell, which is responsible for degrading or breaking down a wide variety of proteins. Carfilzomib has not been approved by the FDA. Rituximab and dexamethasone are often used to treat Waldenstrom's Macroglobulinemia (WM), alone or in combination with other drugs. Combinations with rituximab, dexamethasone and proteasome inhibitors, like carfilzomib, show high levels of activity in WM patients. In this research study, the investigators are testing the safety and efficacy of Carfilzomib when used along with Rituximab and Dexamethasone as a possible treatment for Waldenstrom's Macroglobulinemia.
Primary Outcome
Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Dexamethasone
- DRUG Carfilzomib
Study Locations (1)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT01470196 record still lists
NCT01470196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 157-participant average among 5 other Waldenstrom's Macroglobulinemia trials with a reported enrollment target (80% 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.
NCT01470196 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01470196 about?
NCT01470196 is a clinical study titled "Carfilzomib, Rituximab and Dexamethasone in Waldenstrom's Macroglobulinemia". Carfilzomib is a drug that has shown anti-tumor activity by inhibiting the proteasome within the cell, which is responsible for degrading or breaking down a wide variety of proteins. Carfilzomib has not been approved by the FDA. Rituximab and dexamethasone are often used to treat Waldenstrom's Macr...
What is the current status of trial NCT01470196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-10. Estimated completion is 2016-09.
What conditions does trial NCT01470196 study?
This clinical trial studies the following conditions: Waldenstrom's Macroglobulinemia.
What interventions are being tested in trial NCT01470196?
The interventions under investigation include: Rituximab (DRUG), Dexamethasone (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT01470196?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01470196 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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