Phase 2
Completed N=32
Ixazomib Rollover Study
Multiple Myeloma · Lymphoma · Amyloidosis
Source: ClinicalTrials.gov NCT02924272 ↗
Enrolled (actual)
32
Serious AEs
50.0%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs) — 12; 4 Participants
Summary
The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
12; 4 | — |
| PRIMARY Number of Participants With ≥ Grade 3 AEs |
13; 5 | — |
| PRIMARY Number of Participants With ≥ Grade 2 Peripheral Neuropathy |
2; 0 | — |
| PRIMARY Number of Participants With New Primary Malignancies |
3; 1 | — |
| PRIMARY Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug |
12; 7; 4; 1 | — |
| PRIMARY Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event |
15; 7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02924272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.