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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
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Myeloma Renal Failure Other: Data collection

Detailed Description:
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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Non Relapse Mortality post-transplantation [ Time Frame: 100 days post-transplantation ]
    Non-relapse mortality at Day +100 post-transplantation will be reported.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years post-transplantation ]
    Overall survival at 2 years post-transplantation will be reported.

  2. progression-free survival [ Time Frame: 2 years post-transplantation ]
    progression-free survival at 2 years post-transplantation will be reported.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Myeloma patients with severe renal impairment suseptible of undergoing autologous transplantation.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jérôme Cornillon, MD (0) 4 77 91 70 60 ext +33 jerome.cornillon@icloire.fr
Contact: Elisabeth Daguenet, PhD (0) 4 77 91 70 89 ext +33 Elisabeth.daguenet@icloire.fr

Locations
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Algeria
Centre Pierre et Marie Curie Recruiting
Alger, Algeria
Contact: Abderrahim, MD         
Principal Investigator: Abderrahim         
Sub-Investigator: Hamladji         
Sub-Investigator: Redhouane         
Sub-Investigator: Tensaout         
EHU Oran Recruiting
Oran, Algeria
Contact: Mohamed Amine Bekadja, PhD         
Principal Investigator: Mohamed Amine Bekadja, PhD         
Sub-Investigator: Hafida Ouldjeriouat, MD         
Belgium
CHU Sart Tilman Not yet recruiting
Liège, Belgium
Contact: Yves Beguin, MD         
Principal Investigator: Yves Beguin, MD         
France
Centre Hospitalier Universitaire d'Amiens Recruiting
Amiens, France
Contact: Beaumont, MD         
Principal Investigator: Beaumont         
Sub-Investigator: Delette         
Sub-Investigator: Marolleau         
Sub-Investigator: Merlusca         
Sub-Investigator: Morel         
Centre Hospitalier Universitaire d'Angers Recruiting
Angers, France, 49933
Contact: Mamoum Dib         
Principal Investigator: Mamoum Dib, MD         
Sub-Investigator: Aline Clavert, MD         
Sub-Investigator: Martine Gardembas-Pain, MD         
Sub-Investigator: Marie-Pierre Moles-Moreau, MD         
Sub-Investigator: Aline Schmidt, MD         
Centre Hospitalier d'Argenteuil Recruiting
Argenteuil, France, 95100
Contact: Emmanuelle Le Ray, MD         
Principal Investigator: Emmanuelle Le Ray, MD         
Sub-Investigator: Ahmad Aljijakli, MD         
Sub-Investigator: Annalisa Andreoli, MD         
Sub-Investigator: Driss Chaoui, MD         
Sub-Investigator: Philippe Genet, MD         
Sub-Investigator: Louisa Mesbah, MD         
Centre Hospitalier de la Côte Basque Recruiting
Bayonne, France
Contact: Araujo         
Principal Investigator: Araujo         
Sub-Investigator: Banos         
Sub-Investigator: Capdupuy         
Sub-Investigator: Gay         
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, France
Contact: Annie Brion, MD         
Principal Investigator: Annie Brion, MD         
Sub-Investigator: Anne Charvet, MD         
Sub-Investigator: Adrien Chauchet, MD         
Sub-Investigator: Philippe Delaby, MD         
Sub-Investigator: Jean Fontan, MD         
Centre Hospitalier de Boulogne Not yet recruiting
Boulogne, France
Contact: Bachra Choufi, MD         
Principal Investigator: Bachra Choufi, MD         
Sub-Investigator: Karima Debbache, MD         
CHU de Brest Recruiting
Brest, France
Contact: Gaëlle Guillerm, MD         
Principal Investigator: Gaëlle Guillerm, MD         
Sub-Investigator: Joseph Eveillard, MD         
Sub-Investigator: Marie-Anne Couturier, MD         
Centre Hospitalier Universitaire de Caen Not yet recruiting
Caen, France, 14 000
Contact: Laurent Damaj Gandhi         
Principal Investigator: Laurent Damaj Gandhi, MD         
Sub-Investigator: Margaret Marco, MD         
Centre Hospitalier de Cholet Recruiting
Cholet, France
Contact: Blouet, MD         
Principal Investigator: Blouet         
Sub-Investigator: Zannetti         
Centre Hospitalier Universitaire de Clermont Ferrand Recruiting
Clermont-Ferrand, France
Contact: Jacques-Olivier Bay, PhD         
Principal Investigator: Jacques-Olivier Bay, PhD         
Sub-Investigator: Romain Guieze, MD         
Sub-Investigator: Eric Hermet, MD         
Sub-Investigator: Aurélie Ravinet, MD         
Sub-Investigator: Olivier Tournilhac, PhD         
Sub-Investigator: Richard Lemal, MD         
Centre Hospitalier Universitaire de Dijon Recruiting
Dijon, France, 21 079
Contact: Denis Caillot         
Principal Investigator: Denis Caillot, MD         
Centre Hospitalier Universitaire de Grenoble Recruiting
Grenoble, France, 38 043
Contact: Sophie Park         
Principal Investigator: Sophie Park, MD         
Sub-Investigator: Martin Carre, MD         
Sub-Investigator: Stéphane Courby, MD         
Sub-Investigator: Rémy Gressin, MD         
Sub-Investigator: Clara Mariette, MD         
Sub-Investigator: Lysiane Molina, MD         
Sub-Investigator: Brigitte Prégourié-Bandelier, MD         
Sub-Investigator: Anne Thiébaut, MD         
Sub-Investigator: Claude-Eric Bulabois, MD         
CHU de Limoges Recruiting
Limoges, France
Contact: Arnaud Jaccard, MD         
Principal Investigator: Arnaud Jaccard, MD         
Sub-Investigator: Pascal Turlure, MD         
Sub-Investigator: Marie-Pierre Gourin, MD         
Sub-Investigator: Julie Abraham, MD         
Sub-Investigator: Stéphane Girault, MD         
Sub-Investigator: Mohamed Touati, MD         
Sub-Investigator: Stéphane Moreau, MD         
Sub-Investigator: Liliane Remenieras, MD         
Sub-Investigator: Amélie Penot, MD         
Sub-Investigator: Natalia Dmytruk, MD         
Sub-Investigator: Céline Kennel, MD         
Centre Léon Bérard Recruiting
Lyon, France, 69 373
Contact: Lila Gilis         
Principal Investigator: Lila Gilis, MD         
Sub-Investigator: Souad Assad, MD         
Sub-Investigator: Amine Belhabri, MD         
Sub-Investigator: Laure Lebras, MD         
Sub-Investigator: Anne-Sophie Michallet, MD         
Sub-Investigator: Emmanuelle Nicolas-Virelizier, MD         
Sub-Investigator: Franck Nicolini, MD         
Sub-Investigator: Philippe Rey, MD         
Hôpital Saint-Eloi Recruiting
Montpellier, France, 34 295
Contact: Guillaume Cartron         
Principal Investigator: Guillaume Cartron, MD         
Sub-Investigator: Robert Navarro, MD         
Sub-Investigator: Franciane Paul, MD         
Sub-Investigator: Philippe Quittet, MD         
Sub-Investigator: Emmanuelle Tchernonog, MD         
Centre Hospitalier Universitaire de Nancy Recruiting
Nancy, France, 54 500
Contact: Aurore Perrot         
Principal Investigator: Aurore Perrot, MD         
Hôpital Archet Recruiting
Nice, France
Contact: Valentine Richez, MD         
Principal Investigator: Valentine Richez, MD         
Sub-Investigator: Laurence Legros, MD         
Institut Curie Not yet recruiting
Paris, France, 75 005
Contact: Frédérique Kuhnowski         
Principal Investigator: Frédérique Kuhnowski, MD         
Groupe Hospitalier Pitié-Salpétrière Recruiting
Paris, France, 75 013
Contact: Damien Roos-Weil         
Principal Investigator: Damien Roos-Weil, MD         
Sub-Investigator: Baron         
Sub-Investigator: Jacque         
Hôpital Saint-Antoine Recruiting
Paris, France, 75 020
Contact: Laurent Garderet         
Principal Investigator: Laurent Garderet, MD         
Hôpital Tenon Not yet recruiting
Paris, France, 75 020
Contact: Jean-Jacques Boffa         
Principal Investigator: Jean-Jacques Boffa, MD         
Sub-Investigator: Pierre-Antoine Michel, MD         
Sub-Investigator: Pierre Ronco, MD         
Hôpital Cochin Recruiting
Paris, France
Contact: Bouscary, MD         
Principal Investigator: Bouscary, MD         
Sub-Investigator: Vignon, MD         
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69 495
Contact: Lionel Karlin         
Principal Investigator: Lionel Karlin, MD         
Sub-Investigator: Emmanuel Brachy, MD         
Sub-Investigator: Sauvy Fadhela Bouafia, MD         
Sub-Investigator: Florence Broussais-Guillaumot, MD         
Sub-Investigator: Arthur Dony, MD         
Sub-Investigator: Emmanuelle Ferrant, MD         
Sub-Investigator: Dana Ghergus, MD         
Sub-Investigator: Hervé Ghesquières, MD         
Sub-Investigator: Anne Lazareth, MD         
Sub-Investigator: Violaine Safar, MD         
Sub-Investigator: Clémentine Sarkozy, MD         
Sub-Investigator: Gilles Salles, MD         
Hôpital Saint-Bernard Recruiting
Poitiers, France, 86 021
Contact: Franck Bridoux         
Principal Investigator: Franck Bridoux, MD         
Sub-Investigator: Xavier Leleu, MD         
CHU de Rennes Recruiting
Rennes, France
Contact: Martine Escoffre-Barbe, MD         
Principal Investigator: Martine Escoffre-Barbe, MD         
Sub-Investigator: Marc Bernard, MD         
Sub-Investigator: Brieuc Cherel, MD         
Sub-Investigator: Sophie Guilbert, MD         
Sub-Investigator: Laure Goursaud, MD         
Sub-Investigator: Jean-Baptiste Mear, MD         
Sub-Investigator: Kayane Mheidly, MD         
Sub-Investigator: Aline Moignet, MD         
Sub-Investigator: Stanislas Nimubona, MD         
Sub-Investigator: Olivier Decaux, MD         
Sub-Investigator: Roch Houot, MD         
Sub-Investigator: Thierry Lamy De La Chapelle, MD         
Hôpital Victor Provo (Roubaix) Recruiting
Roubaix, France
Contact: Isabelle Dervite, MD         
Principal Investigator: Isabelle Dervite, MD         
Sub-Investigator: Laurence Detourmignies, MD         
Sub-Investigator: Julie Machin, MD         
Sub-Investigator: Isabelle Plantier, MD         
Sub-Investigator: Mathieu Wemeau, MD         
Sub-Investigator: Abir Fawaz, MD         
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42 270
Contact: Jérôme Cornillon, MD    (0) 4 77 91 70 60 ext +33    jerome.cornillon@icloire.fr   
Principal Investigator: Jérôme Cornillon, MD         
Sub-Investigator: Denis Guyotat, MD         
Sub-Investigator: Fressia Honeyman, MD         
Sub-Investigator: Caroline Lejeune, MD         
Sub-Investigator: Christiane Mounier, MD         
Sub-Investigator: Christelle Portois, MD         
Sub-Investigator: Gilbert Soglu, MD         
Sub-Investigator: Emmanuelle Tavernier, MD         
Sub-Investigator: Philippe Collet, MD         
Centre Hospitalier de Saint Quentin Recruiting
Saint-Quentin, France
Contact: Réda Garidi, MD         
Principal Investigator: Réda Garidi, MD         
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France
Contact: Bruno Lioure, MD         
Principal Investigator: Bruno Lioure, MD         
Sub-Investigator: Bilger         
Sub-Investigator: Fohrer-Sonntag         
Sub-Investigator: Guffroy         
Sub-Investigator: Toussaint         
Lebanon
American University of Beirut Recruiting
Beyrouth, Lebanon
Contact: Ali Bazarbachi, MD         
Principal Investigator: Ali Bazarbachi, MD         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Jérôme Cornillon, MD Institut de Cancérologie Lucien Neuwirth

Additional Information:

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03234335     History of Changes
Other Study ID Numbers: 2017-0702
2017-A02180-53 ( Other Identifier: ANSM )
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de la Loire:
Multiple Myeloma
Renal Failure
Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Melphalan
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Renal Insufficiency
Kidney Diseases
Multiple Myeloma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Urologic Diseases