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

Study Purpose

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. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥ 18 years.
  • - Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment.
  • - MM with disease measurable either by serum evaluation of the monoclonal component or by free light chain assay (serum or urinary) - 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.
  • - Respiratory insufficiency defined as DLCO <40% of the corrected value.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04561492
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nantes University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nantes UH, Nantes, France

Status

Address

Nantes UH

Nantes, ,

Site Contact

Caroline Bodet-Milin, MD, PhD

caroline.milin@chu-nantes.fr