A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."
NCT04998786 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2025-04-06
Summary
This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse .
The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria.
Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.
Conditions
- Multiple Myeloma at First Relapse
Interventions
- DRUG
-
Ixazomib
Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress
- DRUG
-
Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress
- DRUG
-
Dexamethasone Oral
Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22
Sponsors & Collaborators
-
Nantes University Hospital
lead OTHER
Principal Investigators
-
Cyrille Touzeau · Nantes University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-14
- Primary Completion
- 2030-01-01
- Completion
- 2030-01-01
Countries
- France
Study Locations
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