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NCT04009109 · ClinicalTrials.gov registry record · Phase 2

Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

A Phase 2 study of Myeloma Multiple, sponsored by Alliance Foundation Trials.

Active
Registry status
Phase 2
Development phase
79
Enrollment target
7
Study locations

NCT04009109 is a Phase 2 study of Myeloma Multiple that is active but no longer recruiting, run by Alliance Foundation Trials. The registered enrollment target is 79 participants, roughly in line with the 75-participant average among 7 other Myeloma Multiple trials with a reported enrollment target. The trial reports 7 study locations across 6 states.

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The verdict

NCT04009109, a Phase 2 study of Myeloma Multiple, is active but no longer recruiting, sponsored by Alliance Foundation Trials.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
79 participants
Enrollment target
7
Study locations

Study Summary

A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.

Conditions Studied

Myeloma Multiple

Interventions

  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Daratumumab Injection
  • DRUG Ixazomib

Study Locations (7)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

Maine

  • Northern Light Eastern Maine Medical Center - Bangor

Nebraska

  • University of Nebraska Medical Center - Omaha

New York

  • SUNY Upstate Medical Center - Syracuse

North Carolina

  • University of North Carolina - Chapel Hill

South Carolina

  • Gibbs Cancer Center & Research Institute/Spartanburg Regional Healthcare - Spartanburg

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2020-10-21
Est. Completion 2027-06
Phase Phase 2

Sponsor

Alliance Foundation Trials

20 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04009109

The ClinicalTrials.gov registry entry for NCT04009109 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 75-participant average among 7 other Myeloma Multiple trials with a reported enrollment target. The listed sponsor is Alliance Foundation Trials, which has 20 total studies on file at ClinicalTrials.gov.

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

NCT04009109 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Massachusetts, Maine, Nebraska.

Frequently Asked Questions

What is clinical trial NCT04009109 about?

NCT04009109 is a clinical study titled "Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM". A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be r...

What is the current status of trial NCT04009109?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2020-10-21. Estimated completion is 2027-06.

What conditions does trial NCT04009109 study?

This clinical trial studies the following conditions: Myeloma Multiple.

What interventions are being tested in trial NCT04009109?

The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Daratumumab Injection (DRUG), Ixazomib (DRUG).

Who is sponsoring clinical trial NCT04009109?

This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04009109 being conducted?

This trial has 7 study locations across Maine, Massachusetts, Nebraska, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.