Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma

• Status: Completed
• Trial end date: 2017-05-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Glycine; Ixazomib; Proteasome Inhibitors

Criteria

Inclusion Criteria:

Each participant must meet all of the following inclusion criteria to be enrolled in the study:

• Multiple myeloma diagnosed according to the standard criteria.

• Participants with multiple myeloma who have relapsed following at least 2 lines of therapy.

• Participants must have measurable disease.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

• Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.

• Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.

• Voluntary written consent.

• Suitable venous access for study-required blood sampling.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:

• Peripheral neuropathy greater than or equal to (>=) Grade 2.

• Female participants who are lactating or have a positive serum pregnancy test during the screening period.

• Major surgery within 14 days before the first dose of study drug.

• Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment.

• Life-threatening illness unrelated to cancer.

• Diarrhea > Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization.

• Systemic antineoplastic or radiation therapy within 14 days of cytotoxic agents within 21 days before the first dose of study treatment.

• 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 medication.

• Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day. Inhaled and topical steroids are permitted.

• 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.

• Corrected QT interval (QTc) > 470 milliseconds on a 12-lead electrocardiogram (ECG) obtained during the screening period.

• Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.

• Any 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.