Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

The primary objective of this study is to determine the safety profile, tolerability, and maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary objectives include pharmacokinetics and response rates.

Key facts

Study ID

NCT00963820

Run by

Millennium Pharmaceuticals, Inc.

People needed

60

Starts

2009-10-01

Expected to finish

2014-01-01

Last updated by the study team

2018-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Peripheral neuropathy that is greater or equal to Grade 2.
• Major surgery or, serious infections, or infections that required systemic 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 IXAZOMIB including difficulty swallowing.

Where it is running

• Mayo Clinic- Scottsdale — Scottsdale, Arizona, United States
• James R. Berenson, MD, Inc — West Hollywood, California, United States
• University of Chicago — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Weill-Cornell Medical College — New York, New York, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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