Using a new PET scan for staging and evaluating treatment in multiple myeloma
Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment or in Relapse
This study is testing a new type of PET scan to see if it can better help doctors understand and treat multiple myeloma in patients who are starting treatment or have had a relapse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT04561492 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a PET scan using the ligand [68Ga]Ga-PentixaFor in comparison to the standard FDG PET scan for initial staging and therapeutic assessment of symptomatic multiple myeloma patients. It focuses on patients who are either starting first-line treatment or experiencing a relapse. The study will also assess the prognostic significance of CXCR4 expression and explore any discrepancies between the two imaging methods. Participants will undergo PET scans to determine the relevance of this new approach in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic multiple myeloma requiring first-line treatment.
Not a fit: Patients with active infections, significant renal impairment, or those with certain concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved staging and treatment evaluation for patients with multiple myeloma, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar PET imaging approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux and 4 other locations
- CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
- CHU Lille — Lille, France (Not_yet_recruiting)
- Hcl — Lyon, France (Not_yet_recruiting)
- Nantes UH — Nantes, France (Recruiting)
- APHP - Site Tenon — Paris, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Caroline Bodet Milin, MD, PhD
- Email: caroline.milin@chu-nantes.fr
- Phone: 0240084143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.