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Multiple Myeloma

Neoplasms, Plasma Cell

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Immunomodulating Agents

Cilta-cel is a cellular immunotherapy derived from autologous CD3+ T-cells that have undergone ex vivo modification to target B-Cell Maturation Antigen (BCMA) on the surface of plasma cells. Cilta-cel will be administered as two IV infusions, ≥70% unlabeled and ≤30% labelled. The dose will be based on the patient's weight (kg) at apheresis

Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent

Simon Harrison

Mark Dowling

This clinical trial will investigate the in vivo trafficking of cilta-cel in extramedullary myeloma using 64Cu Super Paramagnetic Iron Oxide Nanoparticle (64Cu SPION) and Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)

This a Phase Ib exploratory study designed to investigate the in vivo trafficking of cilta-cel in extramedullary myeloma (EMM) using 64Cu SPION nanoparticles and PET-MRI imaging. It is planned that 10-30% of clinical dose of target number of cilta-cel will be labelled. The target number cilta-cel has been chosen based on the previous first in humans (FIH) study. The rationale to label of cilta-cel in the range of ≤30% is to ensure that reasonable positron emission tomography (PET) and magnetic resonance (MR) imaging quality by increasing the relative labelling dose, in the case low cell numbers are obtained. Additionally, the selected range is chosen to limit cellular toxicity and radiation exposure to the patient from the labelled cells. The unlabeled and labelled dose will be administered as scheduled by a two-part intravenous infusion in which the labelled cells are administered no later than 4hrs after the unlabeled infusion

CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study

Detectable cells by PET assessed by the Deauville score \>3

Incidence, nature and severity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and 2019 American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria for cytokine release syndrome (CRS) and neurotoxicity, Serious Adverse Events (SAE), and Adverse Events of special interest (AESI)

on ctDNA at Day +1, Day +28, 12 weeks, 24 weeks, and 52 weeks post Day +28 and on Bone Marrow Aspirate (BMA) at Day +28 and at suspected CR

Defined as time from first response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) to time to progressive disease (PD)

defined as time from study enrolment to death

Janssen, LP

Peter MacCallum Cancer Centre, Australia

Symptoms and General Pathology

Leukemia

Smoldering Multiple Myeloma

Leukemia, Plasma Cell

Precancerous Conditions

Hypergammaglobulinemia

Plasma Cell Leukemia

Subjects with Monoclonal Gammopathy of Undetermined Significance (MGUS), smouldering Multiple Myeloma (SMM), Multiple Myeloma (MM), Plasma Cell Leukemia (PCL)

Timepoints and samples to be collected are the following:

* bone marrow aspirate, bone marrow biopsy, EMD biopsy, peripheral blood and serum at baseline;
* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum pre-maintenance in TE patients or after 1 year of therapy in Non-Transplant-Eligible (NTE) patients;
* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum during maintenance therapy and only if performed as SOC;
* bone marrow aspirate, bone marrow biopsy, EMD biopsy peripheral blood and serum at 1st and later PD.

storage of biological samples

Antonella Balsamo

Schmitt

Strassl

Krauth

Mikula

Wrobel

Minařík

Stejskal

Hajek

Kessler

Pavlicek

Terpos

Katodrytou

Monaco

Offidani

Cavo

Belotti

Derudas

Antonioli

Aquino

Allegra

Palmieri

Casaluci

Zambello

Mangiacavalli

Martelli

Falcone

Liberati

D'Agostino

Francesca Patriarca

Bila

This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.

This study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples

* bone marrow aspirate, bone marrow biopsy, extramedullary disease (EMD) biopsy, peripheral blood and serum at baseline;
* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum pre-maintenance in TE patients or after 1 year of therapy in non transplant eligible patients;
* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum during maintenance therapy and only if performed as standard of care (SOC);
* bone marrow aspirate, bone marrow biopsy, EMD biopsy peripheral blood and serum at 1st and later progressive disease (PD).

European Myeloma Network (EMN) Sample Project

EMN Prospective Sample Collection Project

Collect biological samples for research studies related to improving medicine and care to the patient

Stichting European Myeloma Network

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study	NCT05666700	Extramedullary ...	Combination Pro...	18 Years -	Peter MacCallum Cancer Centre, Australia
European Myeloma Network (EMN) Sample Project	NCT06237803	Multiple Myelom... Smoldering Mult... Plasma Cell Leu... Extramedullary ... MGUS	storage of biol...	18 Years -	Stichting European Myeloma Network
European Myeloma Network (EMN) Sample Project	NCT06237803	Multiple Myelom... Smoldering Mult... Plasma Cell Leu... Extramedullary ... MGUS	storage of biol...	18 Years -	Stichting European Myeloma Network

Spots Global Cancer Trial Database for extramedullary myeloma