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High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment (IRMYG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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
Show Show 33 study locations
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    
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