High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment (IRMYG)
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|ClinicalTrials.gov Identifier: NCT03234335|
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment|
|Multiple Myeloma Renal Failure||Other: Data collection|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||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)|
|Actual Study Start Date :||April 10, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 1, 2022|
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.
Other: Data collection
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.
- Non Relapse Mortality post-transplantation [ Time Frame: 100 days post-transplantation ]Non-relapse mortality at Day +100 post-transplantation will be reported.
- Overall survival [ Time Frame: 2 years post-transplantation ]Overall survival at 2 years post-transplantation will be reported.
- progression-free survival [ Time Frame: 2 years post-transplantation ]progression-free survival at 2 years post-transplantation will be reported.
- Number of toxicities [ Time Frame: 2 years post-transplantation ]Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years.
- presence of hematological response [ Time Frame: 6 months ]The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported.
- Level of renal response [ Time Frame: 3 months, 6 months and one year ]Level of renal response at 3 months, 6 months and one year post-transplantation will be quantified and reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234335
|Contact: Jérôme Cornillon, MD||(0) 4 77 91 70 60 ext +firstname.lastname@example.org|
|Contact: Elisabeth Daguenet, PhD||(0) 4 77 91 70 89 ext +33||Elisabeth.email@example.com|
|Principal Investigator:||Jérôme Cornillon, MD||Institut de Cancérologie Lucien Neuwirth|