Relapsed and/or Refractory Multiple Myeloma Clinical Trial
Official title:
A Phase 1 Study of MLN9708 in Japanese Patients With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK) of ixazomib alone or in combination with lenalidomide and dexamethasone (Rd), and antitumor activity of ixazomib in participants with RRMM.
The drug being tested in this study is called ixazomib. This study will evaluate the
tolerability, safety, and PK of ixazomib administered alone or in combination with
lenalidomide and dexamethasone in participants with relapsed and/or refractory multiple
myeloma.
This study will enroll approximately 24 participants (3 to 6 participants in each
dose-escalation cohort). Participants will be assigned to receive treatment in one of the
four treatment cohorts:
- Cohort 1: Ixazomib 4.0 mg
- Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
- Cohort 3: Ixazomib 5.5 mg
- Cohort 4: Ixazomib 5.5 mg + Lenalidomide and Dexamethasone
This multi-center trial will be conducted in Japan. The overall time to participate in this
study is approximately 7 years. Participants will make a final visit 29 days after receiving
their last dose of drug for a follow-up assessment.
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