Etude : CONFIRM /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : CONFIRM

Situation thérapeutique : Induction

Traitement : Chimiothérapie / Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 22/02/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude multicentrique randomisée de phase III comparant un traitement continu versus une durée fixe avec le Daratumumab, Lénalidomide et Dexaméthasone dans le myélome multiple en rechute

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The aim of the current protocol is to investigate whether a fixed duration of treatment (24 months) with the Dara-Len-Dex combination is not inferior to the continuous administration of the combination until PD. In this study some patients may have a similar OS while receiving a shorter duration of treatment. This study may allow to deliver a shorter duration of therapy for the treatment of MM at first relapse.

2 arms:
- Experimental: Daratumumab/Lenalidomide/Dexamethasone for 24 months
- Active Comparator: Daratumumab/Lenalidomide/Dexamethasone until progression

Phase : III

Stade : NA

Rechute
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Adult patients (≥ 18 years old)
- Documented MM in relapse according to standard criteria and requiring initiation of a first line salvage therapy.
- Subject must have received one prior line of therapy for MM.
- Subject must have achieved a response (PR or better) to the prior regimen.
- Subject must have an ECOG Performance Status score of 0, 1, or 2.
- For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.
- Signed informed consent
- Affiliation to a social security system or equivalent (recipient or assign)
- Effective method of contraception for the duration of treatment and 3 months after the last dose for women of childbearing age and men with a partner of childbearing age:
-> Progestin-only pill associated with inhibition of ovulation
-> Hormonal methods of contraception, including oral contraceptive pills containing a combination of estrogen + progesterone, vaginal ring, injectables, implants and intrauterine devices (IUDs)
-> non-hormonal IUD
-> Bilateral tubal occlusion
-> Vasectomized partner with documented azoospermia 90 days after procedure and who received a medical assessment of surgical success
-> Intrauterine hormone release system (IUS)
-> Complete Abstinence: Complete abstinence is defined as the complete avoidance of heterosexual intercourse. Complete abstinence is an acceptable form of contraception for all study drugs and must be used throughout the duration of the study and for the duration of time as specified above. It is not necessary to use any other method of contraception when complete abstinence is elected. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.

Critères de non-inclusion : - Evidence of refractoriness or intolerance to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). If previously treated with a lenalidomide or daratumumab-containing regimen, the subject is excluded if he or she:
-> Discontinued due to any severe adverse event related to prior lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) treatment, or
-> If, at any time point, the subject was refractory to any dose of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Refractoriness to lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) is defined either as:
* Subjects whose disease progressed within 60 days of lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody) administration; or
* Subjects whose disease is nonresponsive while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody). Nonresponsive disease is defined as either failure to achieve at least a minimal response or development of progressive disease while on lenalidomide and/or daratumumab (or another anti CD38 monoclonal antibody).
- Subject has received an allogenic stem cell transplant (regardless of timing).
- Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, ie, these subjects should not be enrolled in order to reduce disease burden prior to transplant.
- Subject has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).
- Subject has known MM meningeal involvement.
- Subject has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
- Subject has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures or results, or that, in the opinion, of the investigator would constitute a hazard for participating in this study.
- Subject has known uncontrolled chronic obstructive pulmonary disease (COPD)
- Subject has clinically significant cardiac disease.
- Subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Creatinine clearance ≤30 mL/min (MDRD method) (lenalidomide dose adjustment will be considered for subjects with creatinine clearance 30-60 mL/min).
- Hypersensitivity to the active substance or to any of the excipients
- Pregnancy or lactation women
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03836014
Promoteur :
APHP
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Institut d'Hématologie Bas-Normand (IHBN) - Avenue de la Cote de Nacre - 14000 CAEN

Investigateur :
Margaret MACRO

TEC / ARC / IDE :
Véronique ABONNET
abonnet-v@
chu-caen.fr

Statut de l'essai : OUVERT

MAJ : 22/02/2022