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NCT03314181 · ClinicalTrials.gov registry record · Phase 2

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 2 study of Multiple Myeloma, sponsored by AbbVie.

Active
Registry status
Phase 2
Development phase
156
Enrollment target
20
Study locations

NCT03314181 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 156 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03314181, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
156 participants
Enrollment target
20
Study locations

Study Summary

This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd). Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

Conditions Studied

Multiple Myeloma

Interventions

  • DRUG Venetoclax
  • DRUG Dexamethasone
  • DRUG Daratumumab
  • DRUG Bortezomib

Study Locations (20)

North Carolina

  • Atrium Health Carolinas Medical Center /ID# 164948 - Charlotte
  • Duke Cancer Center /ID# 165104 - Durham
  • Duplicate_Wake Forest Baptist Health /ID# 224447 - Winston-Salem

Victoria

  • Eastern Health /ID# 165850 - Box Hill
  • St Vincent's Hospital Melbourne /ID# 165853 - Fitzroy Melbourne
  • Peter MacCallum Cancer Ctr /ID# 164742 - Melbourne

Massachusetts

  • Beth Israel Deaconess Medical Center /ID# 210904 - Boston
  • Dana-Farber Cancer Institute /ID# 166886 - Boston

New York

  • Duplicate_Roswell Park Comprehensive Cancer Center /ID# 169615 - Buffalo
  • Weill Cornell Medicine/NYP /ID# 167605 - New York

New South Wales

  • The Kinghorn Cancer Centre /ID# 165431 - Darlinghurst
  • St George Hospital /ID# 171063 - Kogarah

Colorado

  • Univ of Colorado Cancer Center /ID# 167331 - Aurora

Florida

  • Moffitt Cancer Center /ID# 169614 - Tampa

Georgia

  • Winship Cancer Institute of Emory University /ID# 165427 - Atlanta

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2018-04-02
Est. Completion 2031-05
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03314181

The ClinicalTrials.gov registry entry for NCT03314181 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (71% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.

NCT03314181 reports 20 study locations spanning 13 distinct geographic areas - top geographies include North Carolina, Victoria, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03314181 about?

NCT03314181 is a clinical study titled "A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma". This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes...

What is the current status of trial NCT03314181?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2018-04-02. Estimated completion is 2031-05.

What conditions does trial NCT03314181 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT03314181?

The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG), Daratumumab (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT03314181?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03314181 being conducted?

This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.