Last updated on May 2020

An Effectiveness and Safety Study of Ixazomib in Combination With Lenalidomide and Dexamethasone (IRD) in Participants With Multiple Myeloma (MM) Previously Receiving a Bortezomib-based Induction Regimen (US MM-6)

Brief description of study

The purpose of this study is to determine the progression-free survival (PFS) at 2 years for MM participants previously receiving a bortezomib-based induction regimen to IRD.

Detailed Study Description

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have MM. This study will look at the effectiveness and safety in participants who take ixazomib in addition to lenalidomide and dexamethasone.

The study will enroll approximately 160 participants. Participants will initially receive:

Ixazomib 4 mg + lenalidomide 25 mg + dexamethasone 40 mg

Participants include MM participants who have received 3 cycles of a bortezomib-based induction regimen (as defined by current National Comprehensive Cancer Network [NCCN] guidelines) and have no evidence of PD following initial first-line therapy. All participants will be asked to take ixazomib 4 mg on Days 1, 8 and 15 and lenalidomide 25 mg from Day 1 through 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 in 28 day cycles until disease progression or unacceptable toxicity for up to 3 years. Dose modifications of ixazomib, and/or lenalidomide and/or dexamethasone are allowed at the discretion of the physician.

This multi-center trial will be conducted in United States. It is anticipated that the treatment phase of this study will last up to 78 months, including 42 months for enrollment, and a 36-month IRD treatment period (39 cycles) with ixazomib and/or lenalidomide and/or dexamethasone for the last participant enrolled.

Participants will make multiple visits to the clinic as per their standard of care, and will be followed for PFS. After disease progression, participants will be followed-up for overall survival every 6 months until death or termination of the study by the sponsor.

Clinical Study Identifier: NCT03173092

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CARTI Cancer Center

Little Rock, AR United States
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Compassionate Care Research Group, Inc.

Fountain Valley, CA United States
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US Oncology Research

Colorado Springs, CO United States
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American Health Network

Greenfield, IN United States
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Hematology Oncology Of Indiana

Indianapolis, IN United States
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Saint Agnes Hospital

Baltimore, MD United States
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Karmanos Cancer Institute

Bloomfield Hills, MI United States
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Fox Chase Cancer Center

Philadelphia, PA United States
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Avera Cancer Institute

Sioux Falls, SD United States
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Texas Oncology - Tyler

Tyler, TX United States
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Central Care Cancer Center

Bolivar, MO United States
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Recruitment Status: Open

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