Schéma : This is a phase II, multicenter, non-randomized, open-label study to evaluate the safety and efficacy of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in patients with newly diagnosed multiple myeloma.
The patient population will consist of adult men and women ≤ 65 years, who have a confirmed diagnosis of standard risk multiple myeloma, who meet eligibility criteria.
Treatment periods will be defined as 21-day cycles for induction, and 28-day cycles for consolidation, and maintenance. Patients will be seen at regular treatment cycle intervals while they are participating in the study.
Patients will be assessed for disease response and progression according to the International Myeloma Working Group criteria at each cycle during induction and consolidation and every other cycle during maintenance.
Eastern Cooperative Oncology Group performance status, adverse events, laboratory values, and vital sign measurements will be collected and assessed to evaluate the safety of therapy throughout the study.
Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events. Patients will attend an End of Treatment visit after receiving their last dose of study drug and will continue to be followed for other follow-up assessments specified in the Schedule of events.
All patients will be followed for survival after progression.
Experimental: four drugs combination
21-day cycles induction, then 28-day cycles consolidation and maintenance with Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab
Current primary outcome:
minimal residual disease-negativity rate [ Time Frame: 22 months ]
after completion of the consolidation therapy and before maintenance
Current secondary outcomes:
- Adverse events [ Time Frame: up to 54 Months ]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- Response rates [ Time Frame: 3 months, 5 months, 7 months, 13 months, 25 months ]
Response rates according to the IMWG criteria after induction, high dose Melphalan, consolidation and maintenance therapy
- Progression free survival [ Time Frame: 54 months ]
- Overall survival [ Time Frame: 54 months ]
Phase : II
Stade : NA