Ixazomib Rollover Study
- Conditions
- Multiple Myeloma, Lymphoma, Systemic Light-chain (AL) Amyloidosis
- Registration Number
- JPRN-jRCT2031210531
- Lead Sponsor
- Fukunaga Shinichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 31
1.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.
2.Previously treated with ixazomib, background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Patients will be eligible to enter the rollover study when:
a.The parent study is closed or planned to be closed; and
b.The patient 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; and
c.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).
3. Agree to continue to practice contraceptive methods as outlined in the parent study.
1. The participant meets any of the criteria for treatment discontinuation in the parent study.
2. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method