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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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
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
...and 11 more locations
Percentage of patients have very good partial response (VGPR) or better
Using IMWG criteria
Time frame: approximate 18 months
Number of adverse events
Number of adverse events defined by Common Terminology Criteria for Adverse Events (v5)
Time frame: approximate 18 months
Number of responses
Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG
Time frame: 3 months
Number of responses
Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG
Time frame: 6 months
Number of the death
is defined as the time in months from inclusion to the date of death due to any cause. Subject alive will be censored at the last known alive date.
Time frame: approximate 18 months
Number of progression
is defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria
Time frame: approximate 18 months
Percentage of time to progression
is defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria
Time frame: approximative 18 months
Percentage of duration of response
is defined as the time from the first response (PR or better) to the date of disease progression or death due to any cause
Time frame: approximative 18 months
Percentage of duration of therapy
is defined as the time from treatment initiation to the last dose of therapy
Time frame: approximative 18 months
Percentage of time to response
according IMWG
Time frame: approximative 18 months
Percentage of Overall Response Rate
according IMWG
Time frame: approximative 18 months
Percentage of value of biological prognostic factors
prognostic factors as ISS stage, cytogenetic as del(17p), t(4;14),
Time frame: day 1
Percentage of frailty scores
age, ECOG, comorbidity index
Time frame: day 1
Percentage of score of quality of life
To assess Quality of Life EQ5D and SF36
Time frame: approximative 18 months
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