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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02180-53 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Institut de Cancérologie de la Loire | OTHER |
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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.
RI is associated with poor prognosis and short median survival (32 months vs 55 months for MM patients with normal renal function). Thus, RI remains a major challenge for hematologists, including decisions on optimal anti-myeloma therapy, potential dialysis, supportive care and quality of life. The combination of a proteasome inhibitor and an immunomodulator is the preferred induction treatment for newly diagnosed transplant-eligible MM patients. After induction, high-dose therapy with Autologous Stem Cell Transplant (ASCT) is the standard of care for these patients. However, concerns related to management of comorbidities and treatment side effects question about therapeutic options for patients with severe renal damage. Of interest, recent studies argued that high-dose therapy followed by ASCT could be a feasible and safe method for renal failure MM patients. Yet, these observations on small sample size patients groups need to be confirmed with standardized conditions. This study proposes to evaluate the efficacy and the safety of this therapeutic strategy in MM patients with severe renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myeloma patients with severe renal impairment | Myeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation will be followed in this study, and data related to the pathology, treatments and transplantation will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Non Relapse Mortality post-transplantation | Non-relapse mortality at Day +100 post-transplantation will be reported. | 100 days post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival at 2 years post-transplantation will be reported. | 2 years post-transplantation |
| progression-free survival | progression-free survival at 2 years post-transplantation will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Myeloma patients with severe renal impairment suseptible of undergoing autologous transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme Cornillon, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Pierre et Marie Curie | Algiers | Algeria | ||||
| EHU Oran |
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| 2 years post-transplantation |
| Number of toxicities | Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years. | 2 years post-transplantation |
| presence of hematological response | The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported. | 6 months |
| Level of renal response | Level of renal response at 3 months, 6 months and one year post-transplantation will be quantified and reported. | 3 months, 6 months and one year |
| Oran |
| Algeria |
| CHU Sart Tilman | Liège | Belgium |
| Centre Hospitalier Universitaire d'Amiens | Amiens | France |
| Centre Hospitalier Universitaire d'Angers | Angers | 49933 | France |
| Centre Hospitalier d'Argenteuil | Argenteuil | 95100 | France |
| Centre Hospitalier de la Côte Basque | Bayonne | France |
| Centre Hospitalier Universitaire de Besançon | Besançon | France |
| Centre Hospitalier de Boulogne | Boulogne | France |
| CHU de Brest | Brest | France |
| Centre Hospitalier Universitaire de Caen | Caen | 14 000 | France |
| Centre Hospitalier de Cholet | Cholet | France |
| Centre Hospitalier Universitaire de Clermont Ferrand | Clermont-Ferrand | France |
| Centre Hospitalier Universitaire de Dijon | Dijon | 21 079 | France |
| Centre Hospitalier Universitaire de Grenoble | Grenoble | 38 043 | France |
| CHU de Limoges | Limoges | France |
| Centre Léon Bérard | Lyon | 69 373 | France |
| Hôpital Saint-Eloi | Montpellier | 34 295 | France |
| Centre Hospitalier Universitaire de Nancy | Nancy | 54 500 | France |
| Hôpital Archet | Nice | France |
| Institut Curie | Paris | 75 005 | France |
| Groupe Hospitalier Pitié-Salpétrière | Paris | 75 013 | France |
| Hôpital Saint-Antoine | Paris | 75 020 | France |
| Hôpital Tenon | Paris | 75 020 | France |
| Hôpital Cochin | Paris | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69 495 | France |
| Hôpital Saint-Bernard | Poitiers | 86 021 | France |
| CHU de Rennes | Rennes | France |
| Hôpital Victor Provo (Roubaix) | Roubaix | France |
| CHU de Saint-Etienne | Saint-Priest-en-Jarez | 42 270 | France |
| Centre Hospitalier de Saint Quentin | Saint-Quentin | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
| American University of Beirut | Beirut | Lebanon |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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