A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."
I2D IFM2021_03
2 other identifiers
interventional
75
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2021
Longer than P75 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedStudy Start
First participant enrolled
December 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
April 6, 2025
April 1, 2025
8.1 years
August 4, 2021
April 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients have very good partial response (VGPR) or better
Using IMWG criteria
approximate 18 months
Secondary Outcomes (13)
Number of adverse events
approximate 18 months
Number of responses
3 months
Number of responses
6 months
Number of the death
approximate 18 months
Number of progression
approximate 18 months
- +8 more secondary outcomes
Study Arms (1)
assessment of treatment Ixazomib, dexamethasone, iberdomide
EXPERIMENTALIberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression
Interventions
Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress
Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress
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
Eligibility Criteria
You may qualify if:
- Age \> 70 years
- Eastern Collaborative Oncology Group (ECOG) performance score of ≤2
- Life expectancy \> 6 months
- Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
- Symptomatic multiple myeloma (MM) at first relapse, as defined below:
- Symptomatic multiple myeloma according to international criteria.(Rajkumar et al, 2014)
- Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy.
- Subject must have received one prior line of therapy for at least 3 cycles.
- Subject has measurable disease at Screening, defined at least one of the following:
- Serum M-protein ≥ 0.5 gram (g)/deciliter (dL), OR
- Urine M-protein ≥ 200 mg in 24 hours, OR
- Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal.
- Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1):
- Absolute neutrophil count (ANC) ≥ 1000/microliter (μL). Subjects may use growth factor support to achieve ANC eligibility criteria.
- Platelet count ≥ 75,000 /mm3 for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells; or a platelet count ≥ 50,000/mm3 for subjects in whom \> 50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts within 3 days before study.
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
CHR
Annecy, France
CH de la cote basque
Bayonne, France
CHRU Hopital Haut Lévêque
Bordeaux, France
CHU
Caen, France
CHU
Clermont-Ferrand, France
CHRU
Dijon, France
CHD les Oudairies
La Roche-sur-Yon, France
CHRU Lille
Lille, France
CHU
Limoges, France
CH Lyon Sud
Lyon, France
CHRU
Nancy, France
CHU
Nantes, France
Hopital de l'archet
Nice, France
CHU Henri Mondor
Paris, France
Hopital St Antoine
Paris, France
Hôpital Cochin
Paris, France
University Hospital
Poitiers, France
CHRU
Rennes, France
ICANS
Strasbourg, France
CHU
Toulouse, France
CHRU Bretonneau
Tours, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cyrille Touzeau
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 10, 2021
Study Start
December 14, 2021
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Last Updated
April 6, 2025
Record last verified: 2025-04