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NCT01478581 · ClinicalTrials.gov registry record · Phase 2
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 11
- Study locations
NCT01478581: Completed Phase 2 study of Multiple Myeloma, sponsored by Pharmacyclics.
NCT01478581 is a Phase 2 study of Multiple Myeloma that has completed, run by Pharmacyclics. The registered enrollment target is 92 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (83% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478581, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 11
- Study locations
Study Summary
The primary objective of this study is to determine the efficacy of PCI-32765, both as a single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and refractory Multiple Myeloma (MM)
Primary Outcome
The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG PCI-32765
Study Locations (11)
New York
- SITE-10 - New York
- SITE-3 - New York
California
- SITE-13 - La Jolla
Maryland
- SITE-5 - Baltimore
Massachusetts
- SITE-4 - Boston
Michigan
- SITE-8 - Ann Arbor
Missouri
- SITE-2 - St Louis
New Jersey
- SITE-6 - Hackensack
Tennessee
- SITE-1 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2012-03 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
What the finished NCT01478581 record still lists
NCT01478581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01478581 lists 11 locations in 10 states (New York, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT01478581 about?
NCT01478581 is a clinical study titled "Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma". The primary objective of this study is to determine the efficacy of PCI-32765, both as a single agent and in combination with dexamethasone, in subjects with relapsed or relapsed and refractory Multiple Myeloma (MM)
What is the current status of trial NCT01478581?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2012-03. Estimated completion is 2018-08.
What conditions does trial NCT01478581 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01478581?
The interventions under investigation include: Dexamethasone (DRUG), PCI-32765 (DRUG).
Who is sponsoring clinical trial NCT01478581?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01478581 being conducted?
This trial has 11 study locations across California, Maryland, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple 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 NCT01478581's enrollment target sits among peer trials
92 181st of 438 higher than 256 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple 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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