Clinical trial · Observational
A Study of Real Life Treatment for Multiple Myeloma (MM)
Local, Multicentre, Non-Interventional Study of Early Diagnostics of Multiple Myeloma Relapses Evaluation in Real Life Practice in the Russian Federation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main aim of this study is to learn how long it takes for people with MM to have a relapse after their first treatment. Not all participants will have a relapse during the study. Participants will visit their clinic every 3 months and be treated according to their clinic's standard practice. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Participants With MM
- description
- Participants diagnosed with MM (complete response \[CR\], very good partial response \[VGPR\] and partial response \[PR\]) and who have received one prior first line treatment within 3 months preceding the enrollment, will be observed retrospectively and medical data will be monitored and collected prospectively every 3 months until the second biochemical and symptomatic relapse is identified.
Primary outcomes (1)
- measure
- Median Time From the Start of First Line Therapy of Participants With MM to First Biochemical Relapse of MM
- timeFrame
- From the start of the first line therapy until first biochemical relapse (up to approximately 4 years)
- description
- According to the International Myeloma Working Group (IMWG), biochemical relapse is diagnosed in participants with relapsing MM based on the following criteria: increase in serum paraprotein by at least 25 percent (%) of nadir (absolute increase should be at least greater than or equal to \[\>=\] 0.5 gram per liter \[g/L\]), increase in urine paraprotein by at least 25% (absolute increase of at least \>=200 milligram per 24 hours \[mg/24 h\]), more than 25% increase in the difference between involved and non-involved free light chains (FLC) with abnormal FLC ratio and absolute increase of at least greater than (\>) 10 milligram per deciliter (mg/dL), increase in plasmacyte infiltration by least \>=10% in participants with non-secretory MM.
Secondary outcomes (26)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. With newly diagnosed multiple myeloma (NDMM) eligible and non-eligible for a high-dose therapy and autologous stem cell transplantation (HDT-ASCT) who have had a response (defined as CR, VGPR, or PR) to the ongoing SoC induction (1st line) therapy that has been started within 3 months before the inclusion. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of inclusion. Exclusion Criteria: 1. With NDMM eligible and non-eligible for a HDT-ASCT who have had SD or PD to the ongoing standard of care (SoC) induction (1st line) therapy that has been started within 3 months before the inclusion. 2. Current, previous (within the last year) or planned (for the next 15-20 months) participation in interventional clinical trial.
References
Publications (0)
Data not yet available