Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma

NCT ID: NCT04561492

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2030-05-21

Brief Summary

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The aim of our study is to confirm the relevance of PET using \[68Ga\]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga -PentixaFor/FDG discordances explored.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[68Ga]Ga-PentixaFor

Group Type EXPERIMENTAL

[68Ga]Ga-PentixaFor

Intervention Type DRUG

Tomography by emission of positons (PET) with theradiopharmaceutic \[68Ga\]Ga-PentixaFor

Interventions

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[68Ga]Ga-PentixaFor

Tomography by emission of positons (PET) with theradiopharmaceutic \[68Ga\]Ga-PentixaFor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
* Written and signed informed consent (obtained on the screening day at the latest and before any investigation)
* ECOG (Eastern Cooperative Oncology Group) \< 2
* Patient affiliated to or beneficiary of the National Health Service

Exclusion Criteria

* HIV positive, active Hepatitis B or C
* Childbearing or child breast feeding women
* Women or men without effective contraceptive barrier if needed
* eGFR \< 50 ml/min by MDRD or CKDEPI
* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Known active infection
* Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus
* Patient under guardianship or trusteeship
* Patient under judicial protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHU Lille

Lille, , France

Site Status NOT_YET_RECRUITING

HCL

Lyon, , France

Site Status NOT_YET_RECRUITING

Nantes UH

Nantes, , France

Site Status RECRUITING

APHP - Site Tenon

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Caroline Bodet Milin, MD, PhD

Role: CONTACT

0240084143 ext. +33

Facility Contacts

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Charles Mesguich

Role: primary

Damien Huglo

Role: primary

Nicolas Jacquet-Francillon

Role: primary

Caroline Bodet-Milin, MD, PhD

Role: primary

Françoise Montravers

Role: primary

Other Identifiers

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2024-516752-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

RC19_0289

Identifier Type: -

Identifier Source: org_study_id

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