A Phase 1/2 Study of MLN9708 Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Study Status

Closed to Enrollment

Study Description

This clinical trial using the oral formulation of MLN9708 has phase 1 and phase 2 components. Both phases will enroll patients with newly diagnosed multiple myeloma who have not previously received systemic treatment. We are currently enrolling patients in the phase 2 component of the trial only.

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.

The purpose of the phase 1 portion of the study is to determine the safety, tolerability and maximum tolerated dose of oral MLN9708, administered weekly, in combination with lenalidomide and low-dose dexamethasone.

The purpose of the phase 2 portion of the study is to find out how well patients respond to treatment with oral MLN9708 in combination with lenalidomide and low-dose dexamethasone.

 

In phase 2, patients will receive in a 28-day cycle:
  •  MLN9708 at the maximum tolerated dose or the recommended phase 2 dose on Days 1, 8 and 15
  • 40 mg of dexamethasone orally on Days 1, 8, 15 and 22
  • lenalidomide 25 mg orally on Days 1 through 21

Disease Status and/or Stage

Untreated Multiple Myeloma

Sponsor

Millennium Pharmaceuticals

Key Eligibility

  • Men and women age 18 and older
  • Previously untreated multiple myeloma
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ruben Niesvizky, MD

Contact

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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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