This protocol is a phase III study designed to compare the efficacy and the safety of Isa-KRd induction, transplant, Isa-KRd post ASCT consolidation and Isa-KRd light consolidation vs KRd induction, transplant, KRd post ASCT consolidation and KRd light consolidation After confirmation of eligibility criteria patients will be randomized to one of the 2 treatment groups in a 1:1 randomization ratio.
This is a open-label randomized phase III study that enrolls newly diagnosed MM patient eligible for high-dose chemotherapy and ASCT. Patients will be randomized at enrolment (1:1, stratification according to ISS Stage \[3 levels: I vs II vs III\] and cytogenetic risk FISH \[2 levels: high-risk vs standard risk/missing\] based on presence of t(4;14), t(14;16), and/or del 17p)) into 2 treatment arms: -ARM A: induction with 4 cycles of Isatuximab-Carfilzomib-Lenalidomide-dexamethasone (Isa-KRd) followed by cyclophophamide and stem cell collections, chemotherapy with Melphalan 200 mg/m2 followed by ASCT (Mel200-ASCT), 4 cycles of Isa-KRd post ASCT consolidation and 12 cycles of Isatuximab-Lenalidomide-Carfilzomib-dexamethasone (IsaKRd) light consolidation; ARM B: induction with 4 cycles of Carfilzomib-Lenalidomide-dexamethasone (KRd) followed by cyclophophamide and stem cell collections, chemotherapy with Melphalan 200 mg/m2 followed by ASCT (Mel200-ASCT), 4 cycles of KRd post ASCT consolidation and 12 cycles of Carfilzomib-Lenalidomide-dexamethasone (KRd) light consolidation. Details of all treatments (dose and schedule) are given in paragraph 8. After light consolidation patients are allowed to receive Lenalidomide maintenance as per standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone (Isa-KRd) versus Carfilzomib-Lenalidomide-Dexamethasone (KRd) in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation
Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone (Isa-KRd) versus Carfilzomib-Lenalidomide-Dexamethasone (KRd) in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation
Rate of MRD negativity after ASCT consolidation treatment by NGS
The rate of MRD negativity is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) after ASCT consolidation treatment using ITT principle. For patients who withdraw from the study or are lost to follow up before four post ASCT consolidation cycles, the best MRD assessment will be considered. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment.
Time frame: The end of consolidation, average of 12 months
Post induction MRD negativity rate by NGS
The rate of MRD negativity after induction is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level, NGS) after the induction phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment/sample not adequate.
Time frame: The end of induction, average of 4 months
Progression-free survival (PFS) in the 2 arms
PFS will be measured from the date of randomization 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 will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
Time frame: approximately up to 5 years
Post light-consolidation MRD negativity rate by NGS
The rate of MRD negativity after light consolidation is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level, NGS) after light consolidation phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment/sample not adequate. Patients 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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Het Ziekenhuisnetwerk Antwerpen - Department of Hematology
Antwerp, Belgium
Fakultni Nemocnice Brno - Internal Hematology and Oncology Clinic
Brno, Czechia
Fakultni Nemocnice Hradec Kralove - 4th Department of Internal Medicine
Nový Hradec Králové, Czechia
Fakultni Nemocnice Ostrava - Department of Haematooncology
Ostrava, Czechia
Vseobecna Fakultni Nemocnice V Praze - Internal Medicine, Hematology Clinic
Prague, Czechia
Medical Center - University Of Freiburg - Department Innere Medizin Klinik für Innere Medizin I
Freiburg im Breisgau, Germany
University Medical Center Hamburg-Eppendorf - Medizinische Klinik und Polikllinik Onkologie und Knochenmarktransplantation, Haematologie
Hamburg, Germany
Klinikum rechts der Isar der TU Muenchen AöR - Innere Medizin III-Haematologie/Onkologie
München, Germany
Alexandra Hospital - Department of Clinical Therapeutics National & Kapodistrian University of Athens School of Medicine
Athens, Greece
Theageneio General Hospital - Department of Hematology Oncology
Thessaloniki, Greece
...and 31 more locations
Time frame: At the end of light-consolidation, average of 24 months
Overall Response Rate (ORR) post-induction
Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after induction.
Time frame: Approx 4 months
Overall Response Rate (ORR) post-transplant
Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after ASCT.
Time frame: Approximately 8 months
Overall Response Rate (ORR) post-consolidation
Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after consolidation.
Time frame: Approximately 12 months
Overall Response Rate (ORR) post light-consolidation
Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after light consolidation.
Time frame: Approximately 24 months
Post ASCT MRD negativity rate by NGS
The rate of MRD negativity after ASCT is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level), NGS using ITT principle. For patients who withdraw from the study or are lost to follow up before ASCT, the best MRD assessment will be considered. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment.
Time frame: After ASCT, approximately 8 months.
MRD negativity rate by NGF post induction
The rate of MRD negativity (by NGF) after induction is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) after the specific phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment. Patients who withdraw from the study or are lost to follow up before MRD evaluation phase, the best MRD assessment will be considered.
Time frame: Approximately 4 months
MRD negativity rate by NGF post induction
The rate of MRD negativity (by NGF) after ASCT is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) after the specific phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment. Patients who withdraw from the study or are lost to follow up before MRD evaluation phase, the best MRD assessment will be considered.
Time frame: Approximately 8 months
MRD negativity rate by NGF post consolidation
The rate of MRD negativity (by NGF) after consolidation is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) after the specific phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment. Patients who withdraw from the study or are lost to follow up before MRD evaluation phase, the best MRD assessment will be considered.
Time frame: Approximately 8 months
MRD negativity rate by NGF post light consolidation
The rate of MRD negativity (by NGF) after light consolidation are determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) after the specific phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment. Patients who withdraw from the study or are lost to follow up before MRD evaluation phase, the best MRD assessment will be considered.
Time frame: Approximately 24 months
Duration of response
Duration of response is defined as the time between first documentation of response (achievement of at least a PR) and PD with deaths owning to causes other than progression not counted, but censored. Responders without disease progression at the cut-off date of final analysis will be censored either at the time of lost to FU, at the time of death due to other cause than PD, or at the at the time of last contact
Time frame: approximately up to 9 years
Duration of MRD negativity (by NGS and NGF)
The duration of MRD Negativity (by NGS and NGF) is defined as time between first MRD Negativity and first MRD positivity. Patients without MRD positivity will be censored at last complete assessment
Time frame: approximately up to 9 years
Determine the rate of sustained for 1-year MRD negativity (by NGF and NGS) from post ASCT consolidation to post light consolidation
Rate of 1 year sustained MRD negativity by NGS (from post ASCT consolidation to post light consolidation) will be also evaluated.
Time frame: approximately up to 9 years
Determine the time to progression (TTP)
From the date of randomization to the date of first disease progression or death per PD, whichever occurs first
Time frame: approximately up to 9 years
Overall Survival (OS)
Overall Survival (OS), measured from the date of from randomization to the date the subject's death
Time frame: approximately up to 9 years
Time to next therapy (TNT)
TNT will be measured from the date of randomization 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 will be censored at the time of the last complete disease assessment. Subjects lost to FU will also be censored at the time of last contact.
Time frame: approximately up to 9 years
Progression-free survival on the next line of therapy (PFS2)
Progression-free survival on the next line of therapy (PFS2) is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first.
Time frame: approximately up to 9 years