Informations générales (source: ClinicalTrials.gov)
Toward a Risk-adapted Strategy to Cure Myeloma : An Intensive Program With Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab as Extended Induction and Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Standard Risk Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant : a Phase II Study of the Intergroupe Francophone du Myélome (IFM) (IFM2018-01)
Interventional
Phase 2
University Hospital, Toulouse (Voir sur ClinicalTrials)
décembre 2018
décembre 2024
07 décembre 2024
The main objective of this study is to evaluate the minimal residual disease-negativity
rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and
Daratumumab as induction and consolidation therapy in an intensive program in newly
diagnosed standard risk multiple myeloma patients.
For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib,
Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification
with autologous stem cell transplantation, consolidation therapy and maintenance.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHRU de Nancy - Nancy - France | Aurore PERROT | Contact (sur clinicalTrials) | |||
| CHU de Caen - Caen - France | Margaret MACRO | Contact (sur clinicalTrials) | |||
| CHU de Dijon - Dijon - France | Denis CAILLOT | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | Philippe MOREAU | Contact (sur clinicalTrials) | |||
| CHU de Rennes - Rennes - France | Martine ESCOFFRE | Contact (sur clinicalTrials) | |||
| CHU de Tours - Tours - France | Lotfi BENBOUBKER | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Lyon - France | Lionel KARLIN | Contact (sur clinicalTrials) | |||
| University Hosptial Toulouse - 31000 - Toulouse - France | Michel Attal, MD PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Lille - Lille - France | Thierry FACON | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Cyrille HULIN | Contact (sur clinicalTrials) | |||
| CHU de Grenoble - Grenoble - France | Clara MARIETTE | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Anne-Marie STOPPA | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- De novo symptomatic myeloma on the International Myeloma Working Group Diagnostic
Criteria for the Diagnosis of Multiple Myeloma
- Measurable disease requiring systemic therapy defined by serum M-component ≥ 10g/l
or urine M-component ≥ 200 mg/24h or involved free light level ≥ 100 mg/l
- Eastern Cooperative Oncology Group performance status 0, 1 or 2
- Eligible to high dose therapy
- De novo symptomatic myeloma on the International Myeloma Working Group Diagnostic
Criteria for the Diagnosis of Multiple Myeloma
- Measurable disease requiring systemic therapy defined by serum M-component ≥ 10g/l
or urine M-component ≥ 200 mg/24h or involved free light level ≥ 100 mg/l
- Eastern Cooperative Oncology Group performance status 0, 1 or 2
- Eligible to high dose therapy
- Previously treated with any systemic therapy for multiple myeloma
- Clinical signs of central nervous system involvement
- Renal insufficiency defined as estimated Glomerular Filtration Rate lower or equal
to 40 ml/min/1.73 m2
- Hepatic impairment defined as aspartate transminase or alanine transaminase greater
or equal to 3 x upper limit of normal, or Total bilirubin greater or equal to 3 x
upper limit of normal
- Platelet count < 75,000 per µL
- Absolute neutrophil count ≤ 1,000 cells/mm3
- Evidence of current uncontrolled cardiovascular conditions
- Female patients who are both lactating and breastfeeding or have a positive serum
pregnancy test during the screening
- Infection requiring systemic antibiotic therapy or other serious infection within 14
days before first dose of study drug
- Grade 3 or higher peripheral neuropathy, or grade 2 with pain, on clinical
examination during the screening period
- Known or suspected chronic obstructive pulmonary disease with a Forced Expiratory
Volume in 1 second < 50% of predicted normal
- Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin,
carbamazepine, phenytoin, phenobarbital), or use of St. John's wort within 14 days
before initiation of the study drug