Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients. (PENTI-MIDAS)

Nantes University Hospital (NUH)

Status and phase: Withdrawn; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: [68Ga]Ga-PentixaFor

Study type: Interventional

Funder types: Other

Identifiers

NCT05321862

RC22_0150

Details and patient eligibility

About

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 detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years.

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria are identical to inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) .

Exclusion criteria

• Non inclusion criteria are identical to non inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) added with:

  1. eGFR < 50 ml/min by MDRD or CKDEPI.
  2. 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.
  3. Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

[68Ga]Ga-PentixaFor

Experimental group

Treatment:

Drug: [68Ga]Ga-PentixaFor