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NCT01564537 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
722
Enrollment target

NCT01564537 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 722 participants.

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The verdict

NCT01564537, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
722 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).

Interventions

  • DRUG Placebo
  • DRUG Dexamethasone
  • DRUG Lenalidomide
  • DRUG Ixazomib

Trial Details

FieldValue
Enrollment Target 722 participants
Start Date 2012-08-01
Est. Completion 2022-02-08
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT01564537

The ClinicalTrials.gov registry entry for NCT01564537 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 722 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01564537 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01564537 about?

NCT01564537 is a clinical study titled "A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma". The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).

What is the current status of trial NCT01564537?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 722 participants. The study started on 2012-08-01. Estimated completion is 2022-02-08.

What interventions are being tested in trial NCT01564537?

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

Who is sponsoring clinical trial NCT01564537?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

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.