Clinical trial · Observational
A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance
Post-authorisation Observational Study for the Assessment of Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance <50 mL/Min/1.73 m2 (CrCl <50 mL/Min/1.73 m2)
NCT02849444CI-TRIAL-00053297MIR50completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
A prospective, multicentre, post-authorisation observational study. The objective of this study is assess the response of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed MM and CrCl \<50 mL/min/1.73 m2.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-myeloma treatment at physician discretion | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Moderate kidney failure
- description
- 30 ≤ CrCl \< 50 mL/min/1.73 m2
- interventionNames
- Other: Anti-myeloma treatment at physician discretion
- label
- Severe kidney failure
- description
- CrCl \< 30 mL/min/1.73 m2
- interventionNames
- Other: Anti-myeloma treatment at physician discretion
Primary outcomes (4)
- measure
- Creatinine levels to determinates Renal function response
- timeFrame
- Up to 12 months
- description
- Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients of both genders, aged equal or more than 18 years.
2. Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria.
3. Patients with documented renal damage defined as creatinine clearance \<50 ml / min / 1.73 m2 (CrCl \<50ml / min / 1.73m2).
4. Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice \*.
5. Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent).
6. Subject with any of the following characteristics (at least one of the 2 following options must be Yes):
* Subjects who have not previously participated in the study
* Subjects who have previously participated in the study, who meet all the inclusion criteria again and to whom none of the exclusion criteria apply, and whose current relapse is consecutive to the relapse that prompted their initial inclusion in the study.
* The decision to prescribe treatment will be clearly dissociated from the decision to include the patient in the study
* Clarification is provided as to the aim of the study, which is to encompass all relapse subcategories included in the International Myeloma Working Group consensus document published in 2006. Therefore, all patients with clinically relapsed multiple myeloma, who are in relapse following a complete response or in progression (including refractory cases) as defined in point 8.1 and in table 4 of the protocol, are considered eligible candidates for participation in the EPA-MIR 50 study, as long as they meet all the other criteria
Exclusion Criteria:
1. Patients who are participating in an interventional clinical trial \* or who refuse to participate in the study.
2. Patients with CrCl \<50 ml / min / 1.73m2 due to a cause other than multiple myeloma properly documented at the discretion of the investigator \*.
* The inclusion of patients who are participating in another observational study is permitted.References
Publications (0)
Data not yet available
No reference posted for this study.