A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide and Dexamethasone in Adults With Relapsed/Refractory Multiple Myeloma
NCT05183139 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2022-05-03
Summary
The main aim is to show that long-term use of ixazomib can improve symptoms of multiple myeloma and provide an effective long-term alternative treatment.
Participants will take ixazomib orally (by mouth) with pomalidomide and dexamethasone or lenalidomide and dexamethasone in 28-day treatment cycles. Participants will be treated for a maximum of 39 cycles but may continue to receive ixazomib beyond 39 cycles if they are benefiting from it. A follow-up study visit will occur 30 days after the last dose of ixazomib. Participants will be monitored for up to 3 years.
Conditions
Interventions
- DRUG
-
Ixazomib
Ixazomib capsules
- DRUG
-
Pomalidomide capsules
- DRUG
-
Lenalidomide capsules
- DRUG
-
Dexamethasone tablets
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-30
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
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