Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma (RHUMM)
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| ClinicalTrials.gov Identifier: NCT05208086 |
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Recruitment Status :
Recruiting
First Posted : January 26, 2022
Last Update Posted : March 18, 2024
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| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Myeloma | Diagnostic Test: Detection of monoclonal component |
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).
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official 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 |
| Actual Study Start Date : | May 18, 2022 |
| Estimated Primary Completion Date : | June 2025 |
| Estimated Study Completion Date : | June 2026 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients
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. |
Diagnostic Test: Detection of monoclonal component
Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample. |
- 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
- 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.
- 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
- 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)
- 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
- 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)
- 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.
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05208086
| Contact: amandine huguet | 0531156338 ext +33 | a.huguet@myelome.fr | |
| Contact: sandrine Rollet | 0531156339 ext +33 | s.rollet@myelome.fr |
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| Principal Investigator: | Olivier DECAUX, PU-PH | Rennes University Hospital |
| Responsible Party: | Intergroupe Francophone du Myelome |
| ClinicalTrials.gov Identifier: | NCT05208086 |
| Other Study ID Numbers: |
IFM 2020-03 |
| First Posted: | January 26, 2022 Key Record Dates |
| Last Update Posted: | March 18, 2024 |
| Last Verified: | March 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Myeloma Monoclonal components detection Urine sample |
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |