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NCT Number: NCT05208086

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Annecy Genevois, Annecy, France

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About this study

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.

180 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Treatment and study plan

Detection of monoclonal component

Diagnostic Test

Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.

Primary outcomes

  1. Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample

    Time frame: at the first Day of Cycle n°2 (each cycle is 28 days or 21 days)

    Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample compared to the reference measurement of 24 hours urine.

    Sensitivity is defined as the proportion, among the patients with positive urinalysis results on 24 hours urine, of positive results on spot urine sample. Evaluation is performed by urine protein electrophoresis and urine immunofixation

Secondary outcomes

  1. Evaluate the specificity of urine monoclonal component detection on spot urine sample

    Time frame: at the first Day of cycle n°2 (each cycle is 28 days or 21 days)

    Evaluate the specificity of urine monoclonal component detection on sample at C2D1 compared to the reference measurement of 24 hours urine sample.

    Specificity is defined as the proportion, among patients with negative urinalysis results on 24 hours urine, of negative results on the spot urine sample.

  2. Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample

    Time frame: at the first day of cycle n°1 and cycle n°4 (each cycle is 28 days or 21 days)

    Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample at C1D1 and C4D1 compared to reference measurement of 24hours urine sample

  3. Compare the responses rate

    Time frame: at the first day of cycle n° 2 and cycle 4 (each cycle is 28 days or 21 days)

    Compare the rate of partial responses, very good partial responses and complete responses (IMWG criteria) but only on the urinary monoclonal component) at C2D1 and C4D1 between the two types of samples (spot urine sample and 24hours urine sample)

  4. Compare the monoclonal component / creatininuria ratios

    Time frame: at the first day of cycle n° 1,2 and 4

    Compare the monoclonal component / creatininuria ratios in both samples (spot urine sample and 24hours urine sample) for components monoclonal which are quantifiable in both types of urine samples

  5. Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease)

    Time frame: at the first day of cycle n° 1 (each cycle is 28 days or 21 days)

    Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease) at C1D1 and on the others points, if the monoclonal component is quantifiable)

  6. Assess the association between the rate of serum light chains and concentration of monoclonal components

    Time frame: at first day of cycle 2 (each cycle is 28 days or 21 days)

    To assess the association between serum light chains and concentration of monoclonal components for both types of urine samples.

  7. Evaluate the urine monoclonal component by the difference between proteinuria and albuminuria

    Time frame: at first day of cycle 2 (each cycle is 28 days or 21 days)

    To Evaluate if the rate of urine monoclonal component (in g/L)could by calculated by the difference between proteinuria (in g/L) and albuminuria (in g/L)

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone du Myelome

Network

Registry information

Official study title

Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma RHU(M)M Random or H24 Urine in (Multiple) Myeloma

Acronym: RHUMM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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