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NCT01794520 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
NCT01794520: Completed Phase 1 study, sponsored by AbbVie.
NCT01794520 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 117 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01794520, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
Study Summary
The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma. The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant di
Interventions
- DRUG Venetoclax
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2012-10-10 |
| Est. Completion | 2021-11-29 |
| Phase | Phase 1 |
What the finished NCT01794520 record still lists
NCT01794520 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% higher).
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT01794520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01794520 about?
NCT01794520 is a clinical study titled "Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma". The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractor...
What is the current status of trial NCT01794520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2012-10-10. Estimated completion is 2021-11-29.
What interventions are being tested in trial NCT01794520?
The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01794520?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01794520's enrollment target sits among peer trials
117 499th of 2000 higher than 1,500 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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