This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of the weekly dosing MLN9708 administered orally in patients with relapsed and refractory multiple myeloma.
Each patient must meet all of the following eligibility criteria to be enrolled in the study:
- Adult patients with multiple myeloma who have relapsed following at least 2 lines of therapy.
- Patients must have measurable disease.
- Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol.
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
- Willing and able to give written informed consent.
- Suitable venous access for study-required blood sampling.
- Peripheral neuropathy that is greater or equal to Grade 2.
- Major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug.
- Life-threatening illness unrelated to cancer.
- Diarrhea that is greater than Grade 1 as outlined in the protocol
- Systemic antineoplastic or radiation therapy within 14 days or cytotoxic agents, or treatment with any investigational products within 21 days before the first dose of study treatment.
- Treatment with any investigational proteasome inhibitor.
- Systemic treatment with prohibited medications that are outlined in the protocol within 14 days of study treatment.
- Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day.
- Central nervous system involvement.
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of MLN9708 including difficulty swallowing.
Last updated: 01/23/2013
NCT ID: NCT00963820