A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone in Adult Patients with Relapsed and/or Refractory Multiple Myeloma

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women whose multiple myeloma is no longer responding to or has not responded to previous treatment (relapsed/refractory). The study is evaluating an experimental drug called MLN9708. 

The purpose of the study is to determine whether adding MLN9708 to the combination of lenalidomide and dexamethasone improves survival in people with relapsed or refractory multiple myeloma. 

Lenalidomide and dexamethasone given in combination is approved by the FDA for treating people with myeloma who have received at least one prior therapy. MLN9708 is a type of drug called proteasome inhibitor. Proteasome inhibitors work by inhibiting proteins (known as proteasomes) that cells need to survive and multiply. Cancer cells are more susceptible to this effect than normal cells. Inhibiting these proteins (proteasomes) may help kill cancer cells.

Study participants will be randomly assigned to one of two treatment groups:

  • Group 1: Lenalidomide and dexamethasone + MLN9708
  • Group 2: Lenalidomide and dexamethasone + placebo (a capsule that looks like MLN9708 but does not contain medication)

Each treatment cycle is 28 days:

  • MLN9708/placebo on Days 1, 8 and 15 of each cycle
  • Lenalidomide on Days 1-21 of each cycle
  • Dexamethasone on Days 1, 8, 15 and 22 of each cycle

MLN9708, lenalidomide and dexamethasone are capsules taken by mouth. Participants may continue to receive treatment as long as their myeloma responds to therapy and they do not experience unacceptable side effects.

Disease Status and/or Stage

Relapsed/Refractory Multiple Myeloma

Sponsor

Millennium

Key Eligibility

  • Men and women age 18 and older
  • Relapsed/refractory multiple myeloma
  • Have received 1 to 3 prior therapies
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ruben Niesvizky, MD

Contact

Protocol ID

MLN 16010

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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