This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.
This is a phase II study with two parallel cohorts of newly diagnosed multiple myeloma (NDMM) patients in at least partial response (PR) after induction with proteasome inhibitors (PIs) plus IMIDs and single or double ASCT Subjects will receive two dose levels of Iberdomide, they will be evaluated for efficacy and safety. In case, in one cohort will be registered unacceptable toxicity, a third cohort will be opened. Subjects will receive treatment until progression, intolerance or unacceptable toxicity. Subsequently subjects will be followed for 24 months. The maximum number of subjects is 130 for cohort 1 and 2, 160 in case a third cohort will be opened.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
IBERDOMIDE (CC220) IN MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS
Centre Hospitalier Universitaire de Bordeaux
Bordeau, France
Efficacy: rate of improvement in response with iberdomide maintenance after autologous stem cell transplantation (ASCT)
Response improvement rate within 6 months will be measured as the number of subjects that improve response according to IMWG criteria (from PR to ≥VGPR; from VGPR to ≥CR; from CR to \>sCR) within the end of sixth cycle of treatment.
Time frame: 6 months of treatment
Rate of dose reductions/discontinuations with iberdomide maintenance after ASCT
Dose reductions/discontinuation rate within 6 months will be measured as the number of subjects that discontinued treatment or have a dose modification within the end of sixth cycle of treatment
Time frame: 6 months of treatment
Rate of next-generation flow (NGF ) minimal residual disease (MRD) conversion from positive to negative.
Rate of NGF Minimal residual disease (MRD) conversion from positive to negative.The MRD conversion rate at 6 months is determined as the proportion of subjects with MRD negativity (\*10-5 sensitivity level, by NGF) after 6 months converted from status as Positive at screening.
Time frame: 6 months of treatment
Rate of next-generation flow (NGF ) minimal residual disease (MRD) conversion from positive to negative.
The MRD conversion rate at 12 months is determined as the proportion of subjects with MRD negativity (\*10-5 sensitivity level, by NGF) after 12 months converted from status as Positive at screening. Subjects who withdraw from the study or are lost to follow up before post 12 months MRD evaluation, the best MRD assessment will be considered
Time frame: 12 months of treatment
Rate of next-generation flow (NGF ) minimal residual disease (MRD) conversion from positive to negative.
The best MRD conversion rate within 12 months is determined as the proportion of subjects with MRD negativity (\*10-5 sensitivity level, by NGF) within 12 months converted from status as Positive at screening. Subjects who withdraw from the study or are lost to follow up before MRD evaluation, the best MRD assessment will be considered.
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Centre Hospitalier Universitaire de Dijon
Dijon, France
CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE
Nantes, France
CHU Hôtel-Dieu
Nantes, France
Saint Antoine Hospital, Hematology Department
Paris, France
C.H.U. Strasbourg
Strasbourg, France
Institut Universitaire Du Cancer De Toulose
Toulouse, France
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens, Greece
Theagenio Cancer Hospital
Thessaloniki, Greece
A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona
Ancona, Italy
...and 12 more locations
Time frame: 12 months of treatment
Rate of adverse events
The analysis of safety as defined by type, frequency and severity will be done primarily by tabulation of the incidence of AEs as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. In the by-subject analysis, a subject having the same event more than once will be counted only once. AEs will be summarized by worst CTCAE grade
Time frame: approximately 60 months
Safety in different subset of subjects with different prognostic features
Determine whether rate of adverse events may change in subgroups with different prognosis according to current prognostic factors
Time frame: approximately 60 months
Efficacy in different subset of subjects with different prognostic features
Determine whether tumor response in terms of response and survival may change in subgroups with different prognosis according to current prognostic factors
Time frame: approximately 60 months
Time to Progression (TTP)
TTP will be measured by protocol from the date of start of therapy and according to ITT from the date of eligibility confirmation to the date of first observation of PD, or deaths for PD. Subjects who have not progressed or who withdraw from the study or die from causes other than PD will be censored at the time of the last disease assessment. Subjects lost to FU will also be censored at the time of last complete disease assessment.
Time frame: approximately 60 months
Progression Free Survival (PFS)
PFS will be measured by protocol from the date of start of therapy and according to ITT from the date of eligibility confirmation to the date of first observation of PD, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study or who were lost to FU will be censored at the time of the last disease assessment.
Time frame: approximately 60 months
Time to next therapy (TNT)
TNT will be measured by protocol from the date of start of therapy and according to ITT from the date of eligibility confirmation to the date of next anti-myeloma therapy. Death due to any cause before starting therapy will be considered an event. Subjects who have not progressed or who withdraw from the study
Time frame: approximately 60 months