Etude : IFM2018-01 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : IFM2018-01

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 05/07/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : 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)

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
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.

Study arms:
Experimental: four drugs combination
21-day cycles induction, then 28-day cycles consolidation and maintenance with Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab
Interventions:
Drug: Ixazomib
Drug: Lenalidomide
Drug: Dexamethasone
Drug: 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

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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

Critères de non-inclusion : - 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
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03669445
Promoteur :
CHU de Toulouse
Type de sponsor : Institutionnel
1, Avenue Irène Joliot Curie
31000 TOULOUSE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Thierry FACON

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : OUVERT

MAJ : 05/07/2019