[68Ga]Ga-PentixaFor positron emission tomography for improved risk and disease assessment in myeloma

Phase 1

• Conditions: Multiple Myeloma; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: CTIS2022-501811-14-00
• Lead Sponsor: niversity Of Antwerp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

All patients who are eligible to start the IMMPROVED study (and signed for participation) can be included in this exploratory study., Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT (Inclusion criteria of the IMMPROVED study). patients can therefore also be included after ASCT, prior to lenalidomide maintenance., Baseline 18F-FDG PET/CT scan (Inclusion criteria of the IMMPROVED study), WHO performance status 0-2 (WHO > 2 can be allowed if the patient is fit for intensive chemotherapy based on the opinion of the physician). (Inclusion criteria of the IMMPROVED study), 18 years of older (Inclusion criteria of the IMMPROVED study), Signed informed consent., Life expectancy > 12 months, based on clinical judgement (Inclusion criteria of the IMMPROVED study), Baseline [68Ga]Ga-PentixaFor PET/CT should be scheduled before starting induction chemotherapy. Exception for patients who will be included after ASCT, but prior to lenalidomide maintenance therapy. (Specific for this study)., An interval of maximum 14 days is allowed between the 18F-FDG and [68Ga]Ga-PentixaFor PET/CT scans (Specific for this study).

Exclusion Criteria

Any physical or physiological condition that may affect adherence to the study protocol, e.g severe claustrophobia or the inability to lie still for 30 minutes., History of concomitant presence of any other malignancy, except for: non-melanoma skin cancer, carcinoma in situ of the cervix, or any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment., Pregnant or breastfeeding, Refusal or inability to provide written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified