Multiple myeloma newly diagnosed transplant-eligible patients MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: NINLARO
Product Name: ixazomib citrate (4mg)
Product Code: MLN9708
Pharmaceutical Form: Capsule
INN or Proposed INN: ixazomib citrate
CAS Number: 1201902-20-3
Other descriptive name: IXAZO
Sponsors
Hospital District of Helsinki and Uusimaa/Helsinki University Hospital HUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Newly diagnosed transplant eligible male or female multiple myeloma patients, 18-70 years of age, who have not received prior treatment for multiple myeloma. Symptomatic and measurable disease diagnosed by standard CRAB and SLIM-CRAB biomarker criteria. Voluntary informed consent. Negative pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Female patients who are lactating or pregnant. Major surgery or radiotherapy within 14 days before enrollment. Central nervous system involvement with myeloma. Active infection requiring systemic antibiotic therapy. Unablity to use thrombosis or herpes zoster prophylaxis or treatment. Grade 1 polyneuropathy with pain or worse.Plasma cell leukemia or amyloidosis. Patients who are not willing to adhere to the pregnant prevention program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to investigate the protocol treatment efficacy based on serological and bone marrow analyses including minimal residual disease assessment by multiparameter flow cytometry and safety of ixazomib + lenalidomide + dexamethasone induction followed by autologous stem cell transplantation, IRd consolidation and ixazomib + lenalidomide or lenalidomide maintenance. Due to serious pandemic caused by COVID-19 (SARS-CoV-2) this protocol has to be amended immediately after the statement of EBMT 16Mar2020. They recommend to postpone the transplantation (ASCT) at least in low risk patient. Patients who would have ASCT straight ahead will receive now the post-ASCT preplanned two consolidation cycles before ASCT and proceed to ASCR when it is safe and possible. Some of patients might therefore even receive maintenance before ASCT. This is mandatory for patients´safety.;Secondary Objective: Proportion of patients achieving MFC-MRD negative status during protocol treatment, progression-free survival, time to next treatment, overall survival. Improvement of responses during consolidation, during risk stratified maintenance and evaluation whether high-risk patients will reach similar PFS, TTNT and OS than standard-and low-risk patients with this escalated therapy. Quality of life and health economy.;Primary end point(s): The primary endpoint is proportion of patients with minimal residual disease < 0.01% assessed by 8-color multiparameter flow cytometry at any time during study protocol treatment.;Timepoint(s) of evaluation of this end point: After induction, after autologous stem cell transplantation, after consolidation and thereafter every six months if near complete remission (CR) or near CR has been achieved. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with negative minimal residual disease assessed by 8-color multiparameter flow cytometry at any time during protcol treatment.;Timepoint(s) of evaluation of this end point: After induction, after autologous stem cell transplantation, after consolidation and thereafter every six months if near complete remission (CR) or near CR has been achieved. | — |
Countries
Finland, Lithuania, Norway, Sweden
Contacts
Public ContactPI Raija Silvennoinen HUCH
Helsinki University Hospital CCC Hematology
Outcome results
None listed