MLN9708 plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone in Adult Patients with Newly Diagnosed Multiple Myeloma

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with multiple myeloma that has not previously been treated.

The purpose of the study is to determine whether adding the experimental drug MLN9708 to the combination of lenalidomide and dexamethasone improves survival in people with newly diagnosed multiple myeloma.

MLN9708 is a type of drug called a 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. Lenalidomide and dexamethasone given in combination is FDA-approved for treating patients with myeloma who have received at least one therapy.

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

  • Arm 1: MLN9708 + lenalidomide + dexamethasone
  • Arm 2: Placebo + lenalidomide + dexamethasone

Treatment cycles are 28 days. Participants will receive MLN9708/placebo capsules by mouth on Days 1, 8 and 15, lenalidomide capsules on Days 1 through 21, and dexamethasone capsules on Days 1, 8, 15 and 22 of each cycle.

Participants will continue to receive treatment for up to 18 cycles as long as they are responding to therapy and not experiencing unacceptable side effects. After 18 cycles, participants may continue therapy in the same randomization arm and with the same treatment schedule with modified dose levels of the study drugs as long as they are responding to therapy.

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Disease Status and/or Stage

Untreated Multiple Myeloma

Sponsor

Millennium

Key Eligibility

  • Men and women age 18 and older with multiple myeloma
  • No prior treatment for multiple myeloma
  • Not eligible for stem cell transplant
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ruben Niesvizky, MD

Contact

Protocol ID

C16014


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Contact Us

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

Erica Bersin
Tel: (646) 962-8232
erb3001@med.cornell.edu

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