Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Monoclonal components detection, Urine sample
Brief summary
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.
Detailed 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. 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).
Interventions
DIAGNOSTIC_TESTDetection of monoclonal component
Monoclonal component analysis by electrophoresis and immnuofixation on the urine sample from miction and 24h urine sample.
Sponsors
Intergroupe Francophone du Myelome
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the specificity of urine monoclonal component detection on spot urine sample | 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 | 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 | 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 | 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) | 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 | 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 | 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) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOROlivier DECAUX, PU-PH
Rennes University Hospital
Outcome results
None listed