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NCT02765854 · ClinicalTrials.gov registry record · Phase 2
Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement
A Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 4
- Study locations
NCT02765854: Completed Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by Emory University.
NCT02765854 is a Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma that has completed, run by Emory University. The registered enrollment target is 70 participants, above the 44-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (59% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02765854, a Phase 2 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 4
- Study locations
Study Summary
This randomized phase II trial studies how well ixazomib and dexamethasone or ixazomib, dexamethasone, and lenalidomide work based on the presence of the rearrangement of a gene called nuclear factor of kappa light polypeptide gene enhancer in B-cells 2 (NFKB2) in treating patients with multiple myeloma that has returned after a period of improvement or does not respond to treatment. Ixazomib may stop the growth of cancer cells by blocking enzymes called proteasomes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system against cancer cells and may also prevent the growth of new blood vessels that tumors need to grow. It is not yet known whether ixazomib and dexamethasone, or ixazomib, dexamethasone, and lenalidomide are more effective in treating multiple myeloma.
Primary Outcome
Comparison to a historical control: The overall response rate (ORR) of each arm at 4 cycles (112 days) is compared to the historical RR of 30%. Arm A or Arm C is designed to detect an improved RR of 60% vs. 30% using Simon's 2-stage Optimum design with a power of at least 90% and an alpha error of 5%., respectively. For Arm B will achieve a power of at least 80% at the significance level of 0.05 to claim that Arm B has equivalent RR as the historical RR of 30% assuming an equivalence tolerance o
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Ixazomib
Study Locations (4)
Georgia
- Grady Memorial Hospital - Atlanta
- Emory University/Winship Cancer Institute - Atlanta
Michigan
- University of Michigan/Rogel Cancer Center - Ann Arbor
Missouri
- Washington University/Siteman Cancer Center - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2023-05-23 |
| Phase | Phase 2 |
What the finished NCT02765854 record still lists
NCT02765854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 44-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (59% higher).
The record links to 2 conditions, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT02765854 reports a single indexed study location in Georgia, Michigan, Missouri.
Frequently Asked Questions
What is clinical trial NCT02765854 about?
NCT02765854 is a clinical study titled "Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement". This randomized phase II trial studies how well ixazomib and dexamethasone or ixazomib, dexamethasone, and lenalidomide work based on the presence of the rearrangement of a gene called nuclear factor of kappa light polypeptide gene enhancer in B-cells 2 (NFKB2) in treating patients with multiple mye...
What is the current status of trial NCT02765854?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2016-09-01. Estimated completion is 2023-05-23.
What conditions does trial NCT02765854 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma.
What interventions are being tested in trial NCT02765854?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT02765854?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02765854 being conducted?
This trial has 4 study locations across Georgia, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell Myeloma
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 NCT02765854's enrollment target sits among peer trials
70 4th of 25 higher than 22 of 25 other Refractory Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Plasma Cell Myeloma 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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