Etude : MagnetisMM-3 / C1071003



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : MagnetisMM-3 / C1071003

Situation thérapeutique : Induction

Traitement : Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : MAGNETISMM-3, an open-label, multicenter, non-randomized phase 2 study of ELRANATAMAB (PF-06863135) monotherapy in participants with multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

STUDY ARMS:
- Experimental: Elranatamab (cohort A - no prior BCMA-directed therapy)
- Experimental: Elranatamab (cohort B - prior BCMA-directed therapy (ADC or CAR T cells))

MAIN OBJECTIVE:
To determine the efficacy of elranatamab in patients with no prior BCMA therapy (Cohort A) and prior BCMA therapy (cohort B).

SECONDARY OBJECTIVES:
- To determine additional efficacy of elranatamab in Cohort A and Cohort B
- To determine the safety and tolerability of elranatamab
- To evaluate the PK of elranatamab
- To evaluate the immunogenicity of elranatamab

Phase : II

Stade : NA

2, 3, 4, X, Rechute, Réfractaire
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 : - Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
- Measurable disease, as defined by at least 1 of the following:
* Serum M-protein >0.5 g/dL by SPEP
* Urinary M-protein excretion >200 mg/24 hours by UPEP
* Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- Refractory to at least one IMiD
- Refractory to at least one PI
- Refractory to at least one anti-CD38 antibody
- Relapsed/refractory to last anti-myeloma regimen
- Cohort A: has not received prior BCMA-directed therapy
- Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
- ECOG performance status ≤2
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
- Not pregnant and willing to use contraception

Critères de non-inclusion : - Smoldering multiple myeloma
- Active Plasma cell leukemia
- Amyloidosis
- POEMS syndrome
- Stem cell transplant within 12 weeks prior to enrollment
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04649359
Promoteur :
PFIZER
Type de sponsor : Industriel
00000 HORS FRANCE

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 :
Docteur Salomon Manier

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

Statut de l'essai : OUVERT

MAJ : 12/10/2021