Status:
COMPLETED
Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Relapsed and Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 multip...
Detailed Description
The drug being tested in this study is ixazomib. Ixazomib is being tested to treat people who have multiple myeloma. This study will look at the safety and efficacy of ixazomib and will enroll approxi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00932698
Start Date
October 12 2009
End Date
May 23 2017
Last Update
August 7 2019
Active Locations (5)
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1
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33617
2
Emory University
Atlanta, Georgia, United States, 30322
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109