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NCT02755597 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy
A Phase 3 study of Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 291
- Enrollment target
- 20
- Study locations
NCT02755597: Completed Phase 3 study of Relapsed/Refractory Multiple Myeloma, sponsored by AbbVie.
NCT02755597 is a Phase 3 study of Relapsed/Refractory Multiple Myeloma that has completed, run by AbbVie. The registered enrollment target is 291 participants, above the 152-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (91% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02755597, a Phase 3 study of Relapsed/Refractory Multiple Myeloma, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 291 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.
Primary Outcome
PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Dexamethasone
- DRUG Bortezomib
- DRUG Placebo for venetoclax
Study Locations (20)
New South Wales
- Royal Prince Alfred Hospital /ID# 149108 - Camperdown
- Concord Repatriation General Hospital /ID# 149106 - Concord
- Liverpool Hospital /ID# 149110 - Liverpool
Victoria
- Box Hill Hospital /ID# 149112 - Box Hill
- Peter MacCallum Cancer Ctr /ID# 149107 - Melbourne
- Alfred Health /ID# 150085 - Melbourne
Colorado
- Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524 - Aurora
- Univ of Colorado Cancer Center /ID# 149130 - Aurora
Western Australia
- Fiona Stanley Hospital /ID# 148967 - Murdoch
- Perth Blood Institute Ltd /ID# 148966 - Nedlands
North Carolina
- Duke Cancer Center /ID# 149099 - Durham
Ohio
- Gabrail Cancer Center Research /ID# 149098 - Canton
Queensland
- Royal Brisbane and Women's Hospital /ID# 149105 - Herston
South Australia
- The Queen Elizabeth Hospital /ID# 149104 - Woodville South
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2016-07-11 |
| Est. Completion | 2022-08-15 |
| Phase | Phase 3 |
What the finished NCT02755597 record still lists
NCT02755597 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, above the 152-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (91% higher).
The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT02755597 names 20 study sites across 14 states, led by New South Wales, Victoria, Colorado.
Frequently Asked Questions
What is clinical trial NCT02755597 about?
NCT02755597 is a clinical study titled "A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy". This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and recei...
What is the current status of trial NCT02755597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2016-07-11. Estimated completion is 2022-08-15.
What conditions does trial NCT02755597 study?
This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma.
What interventions are being tested in trial NCT02755597?
The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG), Placebo for venetoclax (DRUG).
Who is sponsoring clinical trial NCT02755597?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02755597 being conducted?
This trial has 20 study locations across Colorado, North Carolina, Ohio, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02755597's enrollment target sits among peer trials
291 2nd of 14 the highest of 14 other Relapsed/Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsed/Refractory 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.
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