Status and phase
Conditions
Treatments
About
Open-label study to evaluate the safety and efficacy of Ixazomib in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The patient population will consist of adult men and women up to 65 years, who have a confirmed diagnosis of MM who meet eligibility criteria.
Full description
Patients will receive induction therapy, comprising three cycles with Ixazomib, plus Lenalidomide and Dexamethasone.
Peripheral Blood Stem Cells (PBSC) will be mobilized within 2 weeks (+/- 1 week) after the last dose of Lenalidomide, with Cyclophosphamide plus G-CSF or Granulocyte-CSF(Colony Stimulating Factor).
Intensification: High Dose Melphalan (HDM) will be performed within 3 weeks +/- 1 week following stem cell harvest.
After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase:
Early consolidation (consolidation part 1) will start 2 months after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone).
Late consolidation (consolidation part 2) will consist in 6 additional cycles of Ixazomib plus Lenalidomide. No Dexamethasone.
Maintenance therapy will start within 28 days after the last dose of Lenalidomide in last cycle of Late Consolidation for thirteen 28-day cycles (approximately 12 months duration) Patients will be seen at regular treatment cycle intervals while they are participating in the study.
Response will be assessed according to the International Myeloma Working Group (IMWG) criteria until disease progression. All patients will be followed for survival after progression.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Multiple myeloma based on the new IMWG Diagnostic Criteria for plasma cells disorders
Symptomatic myeloma with CRAB criteria
Measurable disease requiring systemic therapy defined by serum M-component ≥ 5g/l or urine M-component ≥ 200 mg/24h or serum FLC ≥ 100 mg/l.
Subjects must not have been treated previously with any systemic therapy for multiple myeloma.
Eligibility for high dose therapy.
Life expectancy ≥ 3 months
ECOG performance status 0, 1 or 2
Patients must meet the following clinical laboratory criteria:
Exclusion criteria
Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening
Evidence of mucosal or internal bleeding and/or platelet refractory.
Prior myeloma systemic therapy
Major surgery within 14 days before first dose of study drug.
Radiotherapy within 14 days before first dose of study drug.
Corticosteroids if exceed the equivalent of 160 mg of dexamethasone within 14 days before first dose of study drug
Central nervous system involvement
Growth factors within 7 days of screening
Transfusion within 7 days of screening
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to first dose of study drug
Infection .
Evidence of current uncontrolled cardiovascular conditions,
Systemic treatment, within 14 days before first dose of study drug, with strong inhibitors of CYP1A2 , strong inhibitors of CYP3A or use of Ginkgo biloba or St. John's wort.
Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis and history of hepatitis B or C virus hepatitis.
Psychiatric illness/social situation that would limit compliance with study requirements.
Known allergy to any of the study medications,
Contraindication to any of the required concomitant drugs
Diagnosed or treated for another malignancy within 5 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease.
Patient has significant neuropathy
Primary purpose
Allocation
Interventional model
Masking
46 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal