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Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma

Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma

Recruiting
18 years and older
All
Phase N/A

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Overview

The primary objective of the study is to evaluate at Day 1 Cycle 2, the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in patients with Multiple Myeloma.

Description

To evaluate the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in Multiple Myeloma patients.

300 evaluable patients are required. For each of them, both spot urine sample and 24h urine sample will be collected at Cycle1 Day1, Cycle 2 Day 1 and Cycle 4 Day 1.

The detection of urine monoclonal component will be performed by urine protein electrophoresis (quantitative) and urine immunofixation (qualitative).

Eligibility

Inclusion Criteria:

  • Patient with Multiple Myeloma
  • Patient starting new treatment line, whatever the line is, but with at least 3 induction cycles
  • Urine monoclonal component ≥ 200mg/24h

Exclusion Criteria:

        -Patients with an emergency planned dexamethasone block administration before the first
        chemotherapy cycle initiation

Study details
    Multiple Myeloma

NCT05208086

Intergroupe Francophone du Myelome

20 March 2024

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