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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01564537

Public ClinicalTrials.gov record NCT01564537. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 11, 2026, 11:00 AM EST

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Official title

A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01564537
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
722 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 1, 2012 (Actual)
Primary completion
Oct 1, 2014 (Actual)
Completion
Feb 8, 2022 (Actual)
Last update posted
Mar 10, 2023

2012 – 2022

United States locations

U.S. sites
18
U.S. states
15
U.S. cities
18
Facility City State ZIP Site status
University of Arkansas Medical Sciences Little Rock Arkansas 72205 —
Pacific Cancer Medical Center Inc Anaheim California 92801 —
West Contra Costa Healthcare District Berkeley California 94704 —
University of Florida Gainesville Florida 32610 —
Cancer & Blood Disease Center Lecanto Florida 34461 —
Northwest Georgia Oncology Center Marietta Georgia 30060 —
John H. Stroger, Jr. Hospital of Cook County Chicago Illinois 60612 —
Dana Farber Cancer Institute Boston Massachusetts 2215 —
Mayo Clinic Rochester Minnesota 55905 —
Hackensack University Medical Center Hackensack New Jersey 7601 —
Roswell Park Cancer Institute Buffalo New York 14263 —
Columbia University Medical Center New York New York 10032 —
Blood and Cancer Clinic Fayetteville North Carolina 28303 —
Scranton Hematology Oncology Scranton Pennsylvania 18510 —
MUSC Hollings Cancer Center Charleston South Carolina 29425 —
Fred Hutchinson Cancer Research Seattle Washington 98109 —
West Virginia University Hospitals and Clinic Morgantown West Virginia 26506-9300 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01564537, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 10, 2023 · Synced Nov 11, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01564537 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →