Clinical trial · Observational
High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment
A Prospective, Non-interventional, Multinational Study Evaluating the Efficacy and the Safety of High Dose Therapy Followed by Autologous Hematopoietic Stem Cell Transplantation as a Frontline Therapy for Myeloma Patients With Severe Renal Impairment (IRMYG Study)
- 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)
Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is recommended when at least one of the myeloma defining events occurs (CRAB features). Renal impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM patients at diagnosis and 40-50% of patients during the course of their disease. To date, there is no defined consensus for the management of myeloma patients with renal failure. It is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.
Conditions
Conditions (2)
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 |
| Renal Failure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Myeloma patients with severe renal impairment
- description
- Myeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation.
- interventionNames
- Other: Data collection
Primary outcomes (1)
- measure
- Non Relapse Mortality post-transplantation
- timeFrame
- 100 days post-transplantation
- description
- Non-relapse mortality at Day +100 post-transplantation will be reported.
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- 2 years post-transplantation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 66 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≤ 66 years-old * Patients with symptomatic, measurable and newly diagnosed multiple myeloma associated: * Severe renal failure at the time of transplantation (creatinine clearance \< 40 ml/min/1.73m², CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration) * Partial response after induction treatment * For patients who undergo autologous transplantation, absence of known contraindication for transplantation * Absence of amylose * Patient affiliated to a social security regimen or beneficiary of the same * Signed written informed consent form Exclusion Criteria: * Patient without at least a partial hematological response following the induction stage * Medical history of previous malignancy * Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9) * Pregnant or breastfeeding woman * Declining participation
References
Publications (0)
Data not yet available