NCT04561492

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
49mo left

Started Sep 2021

Longer than P75 for phase_2 multiple-myeloma

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Sep 2021May 2030

First Submitted

Initial submission to the registry

September 3, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2030

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

8.3 years

First QC Date

September 3, 2020

Last Update Submit

April 15, 2026

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.

    Sensitivity will be assessed by patient and lesion analysis by defining: * True positive (TP): * lesion positive with \[68Ga\]Ga-PentixaFor-PET and positive by FDG-PET * or lesion positive with \[68Ga\]Ga-PentixaFor-PET, negative on FDG-PET but confirmed by another CT scan/ MRI or histology, or confirmed by follow-up (until therapeutic evaluation). * False negative (FN): - lesion negative with \[68Ga\]Ga-PentixaFor-PET and positive by FDG-PET and confirmed by CT or MRI or histology, or confirmed by follow-up.

    1 Month

Secondary Outcomes (12)

  • To determine at the time of initial diagnosis or at relapse, the specificity, the positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET

    1 Month

  • To determine at the time of initial diagnosis or at relapse, the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique

    1 Month

  • To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET

    1 Month

  • To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET

    1 Month

  • To determine at the initial diagnosis or relapse, the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding

    1 Month

  • +7 more secondary outcomes

Study Arms (1)

[68Ga]Ga-PentixaFor

EXPERIMENTAL
Drug: [68Ga]Ga-PentixaFor

Interventions

[68Ga]Ga-PentixaForDRUG

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

[68Ga]Ga-PentixaFor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Bordeaux

Bordeaux, France

Location

Nantes UH

Nantes, France

Location

APHP - Site Tenon

Paris, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 23, 2020

Study Start

September 21, 2021

Primary Completion (Estimated)

December 21, 2029

Study Completion (Estimated)

May 21, 2030

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

FR(3)