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NCT01651039 · ClinicalTrials.gov registry record · Phase 2
Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM)
A Phase 2 study of Multiple Myeloma, sponsored by Ajai Chari.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01651039: Completed Phase 2 study of Multiple Myeloma, sponsored by Ajai Chari.
NCT01651039 is a Phase 2 study of Multiple Myeloma that has completed, run by Ajai Chari. The registered enrollment target is 32 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01651039, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Ajai Chari.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical research study is to find out the effects of a drug called panobinostat (LBH589) when given to people like you with multiple myeloma in combination with the drugs lenalidomide and dexamethasone. The safety of this combination of drugs will also be studied. Your physical state, changes in the state of your multiple myeloma, and laboratory findings taken while on-study will help us decide if panobinostat combined with dexamethasone and lenalidomide is safe and effective. This goal of this study therefore is to determine the activity of the combination of panobinostat thrice weekly every other week, lenalidomide, and weekly dexamethasone in a similar group of subjects. The doses of lenalidomide and dexamethasone will be that which is approved by the FDA for multiple myeloma and you will take each drug at a specific frequency over a 4 week (28 day) period. This period is called a "study cycle".
Primary Outcome
The primary endpoint will be the best overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Panobinostat
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-12-21 |
| Phase | Phase 2 |
What the finished NCT01651039 record still lists
NCT01651039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01651039 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01651039 about?
NCT01651039 is a clinical study titled "Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM)". The purpose of this clinical research study is to find out the effects of a drug called panobinostat (LBH589) when given to people like you with multiple myeloma in combination with the drugs lenalidomide and dexamethasone. The safety of this combination of drugs will also be studied. Your physical ...
What is the current status of trial NCT01651039?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2012-07. Estimated completion is 2016-12-21.
What conditions does trial NCT01651039 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01651039?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT01651039?
This trial is sponsored by Ajai Chari, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01651039 being conducted?
This trial has 1 study location across New York. 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 NCT01651039's enrollment target sits among peer trials
32 324th of 438 higher than 104 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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