Ixazomib Rollover Study

Lab values

• Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.

Other

• The participant meets any of the criteria for treatment discontinuation in the parent study.

• 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.