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NCT00609167 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 2
- Study locations
NCT00609167: Completed Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Mayo Clinic.
NCT00609167 is a Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm that has completed, run by Mayo Clinic. The registered enrollment target is 63 participants, below the 767-participant average among 26 other Multiple Myeloma and Plasma Cell Neoplasm trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00609167, a Phase 2 study of Multiple Myeloma and Plasma Cell Neoplasm, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 2
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide and dexamethasone together with bortezomib may kill more cancer cells. PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together with bortezomib to see how well it works in treating patients with newly diagnosed multiple myeloma.
Primary Outcome
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Componen
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG dexamethasone
- DRUG bortezomib
Study Locations (2)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Ontario
- Princess Margaret Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT00609167 record still lists
NCT00609167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 767-participant average among 26 other Multiple Myeloma and Plasma Cell Neoplasm trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Multiple Myeloma and Plasma Cell Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which cyclophosphamide is the first listed.
NCT00609167 reports a single indexed study location in Arizona, Ontario.
Frequently Asked Questions
What is clinical trial NCT00609167 about?
NCT00609167 is a clinical study titled "Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma". RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell gr...
What is the current status of trial NCT00609167?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2006-12. Estimated completion is 2010-11.
What conditions does trial NCT00609167 study?
This clinical trial studies the following conditions: Multiple Myeloma and Plasma Cell Neoplasm.
What interventions are being tested in trial NCT00609167?
The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00609167?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00609167 being conducted?
This trial has 2 study locations across Arizona, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma and Plasma Cell Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00609167's enrollment target sits among peer trials
63 8th of 26 higher than 19 of 26 other Multiple Myeloma and Plasma Cell Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma and Plasma Cell Neoplasm 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.
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