Multiple MyelomaIRMYGNCT03234335
High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment
An observational study of Multiple Myeloma and Renal Failure, run by Centre Hospitalier Universitaire de Saint Etienne at 33 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Multiple Myeloma, Renal Failure
- What is being tested?
- Data collection
- How many people
- 50 participants
- Where
- 33 sitesin 4 countries
- Study dates
- 10 Apr 2018to 27 Sep 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Myeloma patients with severe renal impairment suseptible of undergoing autologous transplantation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
France29 sites
Centre Hospitalier Universitaire d'Amiens
Amiens
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Centre Hospitalier d'Argenteuil
Argenteuil, 95100
Centre Hospitalier de la Côte Basque
Bayonne
Centre Hospitalier Universitaire de Besançon
Besançon
Centre Hospitalier de Boulogne
Boulogne
CHU de Brest
Brest
Centre Hospitalier Universitaire de Caen
Caen, 14 000
Centre Hospitalier de Cholet
Cholet
Centre Hospitalier Universitaire de Clermont Ferrand
Clermont-Ferrand
Centre Hospitalier Universitaire de Dijon
Dijon, 21 079
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38 043
CHU de Limoges
Limoges
Centre Léon Bérard
Lyon, 69 373
Hôpital Saint-Eloi
Montpellier, 34 295
Centre Hospitalier Universitaire de Nancy
Nancy, 54 500
Hôpital Archet
Nice
Institut Curie
Paris, 75 005
Groupe Hospitalier Pitié-Salpétrière
Paris, 75 013
Hôpital Saint-Antoine
Paris, 75 020
Hôpital Tenon
Paris, 75 020
Hôpital Cochin
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69 495
Hôpital Saint-Bernard
Poitiers, 86 021
CHU de Rennes
Rennes
Hôpital Victor Provo (Roubaix)
Roubaix
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42 270
Centre Hospitalier de Saint Quentin
Saint-Quentin
Hôpitaux Universitaires de Strasbourg
Strasbourg
About this study
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)
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.
Read the 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.
- Conditions
- Multiple Myeloma, Renal Failure
- Being tested
- Data collection
- Keywords
- Multiple Myeloma, Renal Failure, Autologous Hematopoietic Stem Cell Transplantation (ASCT), Melphalan
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non Relapse Mortality post-transplantation
Non-relapse mortality at Day +100 post-transplantation will be reported.
Measured: 100 days post-transplantation
Secondary outcomes (5)
Overall survival
Overall survival at 2 years post-transplantation will be reported.
Measured: 2 years post-transplantation
progression-free survival
progression-free survival at 2 years post-transplantation will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start10 Apr 2018
- Primary completion29 Sep 2020
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Jérôme Cornillon, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234335
- Sponsor's protocol ID
- 2017-0702
- Other IDs
- 2017-A02180-53
- Acronym
- IRMYG
- Status last verified
- May 2023
- First submitted
- 26 Jul 2017
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03234335
- Acronym / sponsor ID
- IRMYG / 2017-0702
- Conditions
- Multiple Myeloma, Renal Failure
- Keywords
- Multiple Myeloma, Renal Failure, Autologous Hematopoietic Stem Cell Transplantation (ASCT), Melphalan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myeloma patients with severe renal impairment | – | Other: Data collectionMyeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Myeloma patients with severe renal impairment suseptible of undergoing autologous transplantation.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionMyeloma 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. | Other | Myeloma patients with severe renal impairment |
Primary outcome
Non Relapse Mortality post-transplantation
Time frame: 100 days post-transplantation
Non-relapse mortality at Day +100 post-transplantation will be reported.
5 secondary outcomes
Overall survival
Time frame: 2 years post-transplantation
progression-free survival
Time frame: 2 years post-transplantation
Number of toxicities
Time frame: 2 years post-transplantation
presence of hematological response
Time frame: 6 months
Level of renal response
Time frame: 3 months, 6 months and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Cornillon, MD principal investigator
CHU de Saint-Etienne
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Renal Failure, run by Centre Hospitalier Universitaire de Saint Etienne at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France, Algeria, Belgium, Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non Relapse Mortality post-transplantation (time frame: 100 days post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.