Ixazomib Rollover Study
Multiple Myeloma, Lymphoma, Amyloidosis
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Emory University
- Appalachian Regional Healthcare
- Dana Farber Cancer Institute
- Washington University School of Medicine
- UZ Leuven
- Princess Margaret Cancer Centre
- University Health Network
- Peking University Third Hospital
- Peking Union Medical College Hospital
- 1st Affiliated Hospital of Zhejiang University
- Shanghai Chang Zheng Hospital
- Laiko General Hospital of Athens
- University of Athens Medical School - Regional General Hospital Alexandra
- Tokyo Metropolitan Komagome Hospital
- Japanese Red Cross Medical Center
- Asan Medical Center - PPDS
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
- Centrum Onkologii Ziemi Lubelskiej
- MTZ Clinical Research Sp z o o
- National University Hospital
- Complejo Asistencial Universitario de Salamanca H. Clinico
- Hospital Universitario de Donostia
- Karolinska Universitetssjukhuset Huddinge
- Skanes Universitetssjukhus Lund
- Karolinska Universitetssjukhuset Solna
Arms of the Study
Arm 1
Experimental
Ixazomib
Ixazomib capsule, orally, at same dose and schedule that participants were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant is transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, whichever is sooner. Participants who were receiving a combination therapy with ixazomib and another medication(s) will continue to receive the combination regimen.