Ixazomib Rollover Study

Completed · Phase 2

Conditions studied: Multiple Myeloma, Lymphoma, Amyloidosis

In brief

The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.

Key facts

Study ID

NCT02924272

Run by

Takeda

People needed

32

Starts

2016-12-16

Expected to finish

2024-07-03

Last updated by the study team

2025-03-12

Who can join

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

You may qualify if…

• Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of treatment in the parent study or as agreed by the Takeda clinician/designee.
• Previously treated with ixazomib, background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Participants will be eligible to enter the rollover study when:
• The parent study is closed or planned to be closed; and
• The participant is on ixazomib monotherapy, a combination regimen with ixazomib and other study medication(s), on a placebo combination, or on an alternative arm regimen in a designated ixazomib parent study (i.e., Studies C16003 [NCT00932698], C16005 [NCT01217957], C16006 [NCT01335685], C16007 [NCT01318902], C16008 [NCT01383928], C16010 Global [NCT01564537], C16011 [NCT01659658], C16013 [NCT01645930], C16014 Global [NCT01850524] and Korean Continuation, C16017 [NCT01939899], C16020 [NCT02046070], C16029 [NCT03170882], and C16047 [NCT03439293]); and
• In the opinion of the investigator and approved by the Takeda medical monitor, the participant may continue to benefit from treatment with ixazomib and/or another study drug/combination regimen (e.g., response to therapy or stable disease without evidence of disease progression) and has no alternate means to access the study drug(s) (e.g., commercial supply).
• Agree to continue to practice contraceptive methods as outlined in the parent study.

You may not qualify if…

• The participant meets any of the criteria for treatment discontinuation in the parent study.
• Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.

Where it is running

• Emory University — Atlanta, Georgia, United States
• Appalachian Regional Healthcare — Hazard, Kentucky, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• UZ Leuven — Leuven, Belgium
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• University Health Network — Toronto, Ontario, Canada
• Peking University Third Hospital — Beijing, Beijing Municipality, China
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• 1st Affiliated Hospital of Zhejiang University — Hangzhou, China
• Shanghai Chang Zheng Hospital — Shanghai, China
• Laiko General Hospital of Athens — Athens, Attica, Greece
• University of Athens Medical School - Regional General Hospital Alexandra — Athens, Greece
• Tokyo Metropolitan Komagome Hospital — Bunkyo-Ku, Tokyo, Japan
• Japanese Red Cross Medical Center — Shibuya-Ku, Tokyo, Japan
• Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich — Chorzów, Silesian Voivodeship, Poland
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi — Lodz, Poland
• Centrum Onkologii Ziemi Lubelskiej — Lublin, Poland
• MTZ Clinical Research Sp z o o — Warsaw, Poland
• National University Hospital — Singapore, Singapore
• Asan Medical Center - PPDS — Seoul, South Korea
• Hospital Universitario de Donostia — Donostia / San Sebastian, Spain
• Complejo Asistencial Universitario de Salamanca H. Clinico — Salamanca, Spain
• Karolinska Universitetssjukhuset Huddinge — Stockholm, Södermanland County, Sweden
• Skanes Universitetssjukhus Lund — Lund, Sweden

Full record on ClinicalTrials.gov

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