An Open Label, Dose Escalation, Phase 1 Study Evaluating the Safety and Tolerability of Weekly Dosing of the Oral Form of MLN9708, a Second Generation Proteasome Inhibitor, in Adult patients with Relapsed and Refractory Multiple Myeloma

Study Status

Closed to Enrollment

Study Description

This is one of the first two studies of the capsule form of the experimental drug MLN9708, administered orally, in people with relapsed and refractory multiple myeloma.

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 this study is to determine:

  • The side effects and risks of MLN9708
  • The highest dose of the study drug that can be given to patients with multiple myeloma without causing side effects and risks that are too severe
  • How much MLN9708 is in your blood and how your body gets rid of the drug
  • How MLN9708 affects the cancer cells and how they grow
Patients will be administered MLN9708 orally on Days 1, 8, and 15 during a 28-day treatment cycle.  Patients, including those who achieve a Complete Response (CR), may receive MLN9708 until their disease progresses, or they experience an unacceptable toxicity. The maximum duration of treatment, however, will be 12 months unless, after discussion between the study physician and the study sponsor, it is determined that a patient would derive benefit from continued therapy beyond 12 months.  Patients will be followed for 30 days after the last dose of MLN9708 to permit the detection of any delayed treatment-related side effects.

Disease Status and/or Stage

Relapsed or Refractory Multiple Myeloma

Sponsor

Millennium Pharmaceuticals

Key Eligibility

  • Men and women age 18 and older
  • Multiple myeloma, relapsed following at least 2 lines of therapy
  • 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
roh2026@med.cornell.edu

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