Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Exanthema

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Cycle1 day1: collection of 24h urine and an urine sample from miction the day of the visit.

Cycle 2 day1:collection of 24h urine and an urine sample from miction the day of the visit Cycle 4 day 1: collection of 24h urine and an urine sample from miction the day of the visit.

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

Detection of monoclonal component

amandine huguet

sandrine Rollet

Frédérique ORSINI PIOCELLE, MD

Arthur DONNY

Marie-Lorraine CHRETIEN, MD

Mouad TIAB

Rakiba BELKHIR, MD

Kamel LARIBI, MD

Daniela ROBU

Lionel Karlin, MD

Laure VINCENT, MD

Laure Vincent

Muriel Newinger-Porte

Cyrille TOUZEAU, MD

Xavier LELEU, MD

Aurore Perrot, MD

Thomas CHALOPIN, MD

Brieuc CHEREL, MD

Sophie Rigaudeau, MD

Olivier DECAUX, PU-PH

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.

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).

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 RHU(M)M Random or H24 Urine in (Multiple) Myeloma

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

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.

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

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)

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

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)

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

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma	NCT05208086	Multiple Myelom...	Detection of mo...	18 Years -	Intergroupe Francophone du Myelome
Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma	NCT05208086	Multiple Myelom...	Detection of mo...	18 Years -	Intergroupe Francophone du Myelome

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