Titre officiel
A Phase 2 Multi-Centre, Open Label Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in Newly Diagnosed, Transplant Eligible Multiple Myeloma
Sommaire:
Il s’agit d’une étude multicentrique ouverte de phase II à
groupe unique, visant à évaluer l’innocuité et l’efficacité de l’isatuximab
administré par voie intraveineuse en association avec un traitement d’induction
selon le protocole CyBorD et un traitement d’entretien par la lénalidomide
durant un cycle de 28 jours chez des patients admissibles à une autogreffe
de cellules souches.
Description de l'essai
Primary Outcome:
- Response rate (VGPR or better) defined by IMWG criteria
This
is a phase II, multicenter, open label, single arm study that will
evaluate the safety and efficacy of Isatuximab administered
intravenously at 10 mg/kg in combination with CyBorD induction treatment
and Lenalidomide maintenance treatment in a 28-day long cycle in
autologous stem cell transplant-eligible patients.
The induction treatment
consists of four cycles of Isa-CyBorD. Isatuximab will be given on days
1, 8, 15 and 22 of cycle 1 and days 1 and 15 of cycle 2-4 in combination
with Cyclophosphamide at 300 mg/m2 on days 1, 8, 15 and 22, Bortezomib
at 1.5 mg/m2 on days 1, 8, 15 and 22 and Dexamethasone at 40 mg on days
1, 8, 15 and 22 of each 28-day cycle.
Following the induction
phase, all subjects achieving at least stable disease will have stem
cell mobilization per standard institutional procedures. This is
followed by high dose chemotherapy (Melphalan 200 mg/m2) and autologous
stem cell transplantation.
((If, for unexpected
logistical reason, there is a foreseen delay of stem cell mobilization
or transplantation of more than eight weeks after the end of cycle four
of induction, an additional cycle of Isa-CyBorD can be given at the
investigator's discretion.))
The maintenance
treatment consisting of Isatuximab at 10 mg/kg administered
intravenously on days 1, 8, 15 and 22 of cycle 1, days 1 and 15 of cycle
2 and 3 and day 1 all subsequent 28-day maintenance cycles in
combination with Lenalidomide administered orally at 10 mg on days 1-21
of each 28-day cycle will be administered starting at day 100 (+/- 7
days) after the transplant. Lenalidomide, if tolerated well, will be
increased to 15 mg starting with cycle 3.
Voir cet essai sur ClinicalTrials.gov
