A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Plasma Cell Myeloma Clinical Trial

— IONA-MM  

Official title:

A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458831
• Other study ID #: OBS16577
• Status: Recruiting
• Start date: August 13, 2020
• Est. completion date: February 23, 2026

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-Us[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months

To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice

To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice

To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)

To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)

Secondary Objective:

Not applicable

Description:

Duration per participant is 2.5 years

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 23, 2026
• Est. primary completion date: February 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Age =18 years

• Patients with RRMM who have at least one prior line of therapy

• Patients for whom the treating physician has made the decision to initiate isatuximab per routine practice and independently of the purpose of the study; for retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of three months prior to study enrollment

• Able to understand and complete the study-related questionnaires

• Patient must have given signed informed consent prior to study start. For retrospectively enrolled patients who are deceased at the date of enrollment into the study, a waiver of consent will be required; patients who have started and stopped treatment up to three months before ICF are eligible .

Most important exclusion criteria for potential participants:

Patients who are receiving isatuximab for an indication other than RRMM

• Patients who have received any other investigational drug or prohibited therapy for this study within 28 days or five half-lives from randomization, whichever is longer

• Patients having contraindication to the isatuximab summary of product characteristics (SMPC) or package insert (PI)

• Patients having contraindications as noted in the drug-specific local isatuximab SMPC/PI of combination drugs

• Any country-related specific regulation that would prevent the patient from entering the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Drug:
• isatuximab SAR650984
Pharmaceutical form: solution for infusion Route of administration: intravenous
• Pomalidomide
Pharmaceutical form: oral
• Dexamethasone
Pharmaceutical form: oral
• Carfilzomib
Pharmaceutical form: solution for infusion

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320004	Buenos Aires
Argentina	Investigational Site Number : 0320001	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Investigational Site Number : 0320002	Cordoba
Austria	LKH Steyr - Investigational Site Number : 0400002	Steyr
Austria	Investigational Site Number : 0400003	Wien
Belgium	Institut Jules Bordet - Investigational Site Number : 0560001	Anderlecht
Belgium	AZ Nikolaas - Investigational Site Number : 0560002	Sint Niklaas
China	Investigational Site Number : 1560002	Guangzhou
China	Investigational Site Number : 1560001	Shenzhen
France	Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007	Argenteuil
France	Investigational Site Number : 2500017	Cahors
France	Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006	Chambéry
France	Investigational Site Number : 2500012	Essey les Nancy
France	Centre Hospitalier Le Mans - Investigational Site Number : 2500015	Le Mans Cedex
France	Investigational Site Number : 2500013	Lille
France	Investigational Site Number : 2500004	Montpellier Cedex 5
France	Investigational Site Number : 2500009	Pessac cedex
France	CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008	Poitiers
France	CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010	Reims
France	Investigational Site Number : 2500001	Rouen
France	Investigational Site Number : 2500005	Saint Priest En Jarez
France	Investigational Site Number : 2500014	Saint Quentin cedex
France	Investigational Site Number : 2500016	Tarbes
France	Investigational Site Number : 2500003	Toulouse
France	Investigational Site Number : 2500011	Vannes Cedex
Germany	Investigational Site Number : 2760014	Aschaffenburg
Germany	Investigational Site Number : 2760016	Aschaffenburg
Germany	Investigational Site Number : 2760025	Bad Liebenwerda
Germany	Investigational Site Number : 2760017	Baden-Baden
Germany	Investigational Site Number : 2760020	Bamberg
Germany	Investigational Site Number : 2760018	Bayreuth
Germany	Investigational Site Number : 2760003	Berlin
Germany	Investigational Site Number : 2760022	Berlin
Germany	Investigational Site Number : 2760041	Berlin
Germany	Praxis am Volkspark - Investigational Site Number : 2760009	Berlin
Germany	Investigational Site Number : 2760007	Donauwoerth
Germany	GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001	Dortmund
Germany	Investigational Site Number : 2760002	Dresden
Germany	Investigational Site Number : 2760035	Dresden
Germany	Investigational Site Number : 2760037	Frankfurt
Germany	Investigational Site Number : 2760010	Frankfurt am Main
Germany	Investigational Site Number : 2760015	Goslar
Germany	Investigational Site Number : 2760012	Hannover
Germany	Investigational Site Number : 2760013	Herrsching
Germany	MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034	Koeln
Germany	Investigational Site Number : 2760026	Kulmbach
Germany	Investigational Site Number : 2760008	Leipzig
Germany	Investigational Site Number : 2760011	Magdeburg
Germany	Investigational Site Number : 2760038	Marburg
Germany	Investigational Site Number : 2760006	Muenchen
Germany	Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042	Mutlangen
Germany	Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044	Neubrandenburg
Germany	Investigational Site Number : 2760021	Oldenburg
Germany	Investigational Site Number : 2760036	Oldenburg
Germany	Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039	Potsdam
Germany	Investigational Site Number : 2760040	Stolberg
Germany	Investigational Site Number : 2760031	Weilheim
Germany	Investigational Site Number : 2760019	Wuerzburg
Hong Kong	Investigational Site Number : 3440001	Hong Kong
Italy	Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005	Bologna
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007	Brescia
Italy	Investigational Site Number : 3800003	Milan
Italy	Investigational Site Number : 3800001	Napoli
Italy	Investigational Site Number : 3800008	Novara
Italy	Investigational Site Number : 3800002	Rome	Roma
Italy	Investigational Site Number : 3800009	Rome	Roma
Italy	Investigational Site Number : 3800010	Treviso
Japan	Investigational Site Number : 3920010	Fukuoka-shi
Japan	Investigational Site Number : 3920002	Kamogawa-shi
Japan	Investigational Site Number : 3920007	Kashiwa-shi
Japan	Investigational Site Number : 3920004	Minato-ku	Tokyo
Japan	Investigational Site Number : 3920013	Minato-ku
Japan	Investigational Site Number : 3920005	Okayama-shi
Japan	Investigational Site Number : 3920009	Osaka-shi	Osaka
Japan	Investigational Site Number : 3920014	Osakasayama-shi
Japan	Investigational Site Number : 3920012	Sapporo-shi	Hokkaido
Japan	Investigational Site Number : 3920008	Shibukawa-shi
Japan	Investigational Site Number : 3920006	Shibuya-ku	Tokyo
Japan	Investigational Site Number : 3920003	Sunto-gun	Shizuoka
Japan	Investigational Site Number : 3920011	Suwa-shi
Japan	Investigational Site Number : 3920001	Yamagata-shi
Netherlands	Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001	Dordrecht
Puerto Rico	Puerto Rico Medical Research Center, LLC Site Number : 8400001	Hato Rey
Puerto Rico	Auxilio Mutuo Cancer Center Site Number : 8400029	San Juan
Spain	Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010	Granada
Spain	Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005	Leon	León
Spain	Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006	Malaga	Málaga
Spain	Hospital Universitari Son Espases - Investigational Site Number : 7240003	Palma de Mallorca
Spain	Investigational Site Number : 7240009	Pamplona	Navarra
Spain	Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011	Pontevedra
Spain	omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007	San Cristobal De La Laguna
Spain	Investigational Site Number : 7240004	Toledo
Switzerland	Investigational Site Number : 5760003	Baden
Switzerland	Investigational Site Number : 5760001	Bern
Switzerland	Stadtspital Triemli - Investigational Site Number : 5760002	Zürich
Taiwan	Investigational Site Number : 1580002	Kaohsiung
United Arab Emirates	Investigational Site Number : 7840001	Abu dhabi
United Arab Emirates	Investigational Site Number : 7840002	Abu Dhabi
United Kingdom	Investigational Site Number : 8260004	Huddersfield
United Kingdom	Freeman Hospital - Investigational Site Number : 8260003	Newcastle Upon Tyne
United Kingdom	Investigational Site Number : 8260002	Nottingham	Nottinghamshire
United Kingdom	Investigational Site Number : 8260005	Sutton	Surrey
United States	Hematology & Oncology Associates Site Number : 8400015	Canton	Ohio
United States	Charleston Hematology Oncology Associates, PA Site Number : 8400020	Charleston	South Carolina
United States	Michigan Center of Medical Research Site Number : 8400010	Farmington Hills	Michigan
United States	Holy Cross Hospital Site Number : 8400030	Fort Lauderdale	Florida
United States	Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017	Freehold	New Jersey
United States	St. Joseph Heritage Healthcare Site Number : 8400008	Fullerton	California
United States	Central Care Cancer Center Site Number : 8400006	Garden City	Kansas
United States	Central Care Cancer Center Site Number : 8400019	Garden City	Kansas
United States	Prisma Health - Eastside Office Site Number : 8400011	Greenville	South Carolina
United States	MD Anderson Cancer Center Site Number : 8400013	Houston	Texas
United States	Regional Cancer Care Associates Site Number : 8400024	Howell	New Jersey
United States	GenesisCare Site Number : 8400007	Jacksonville	Florida
United States	AMR Kansas City Site Number : 8400016	Kansas City	Missouri
United States	Watson Clinic Cancer and Research Center Site Number : 8400023	Lakeland	Florida
United States	Central Maine Medical Center Site Number : 8400031	Lewiston	Maine
United States	University of Arkansas Medical Sciences Site Number : 8400021	Little Rock	Arkansas
United States	Regional Cancer Care Associates - Little Silver Division Site Number : 8400018	Little Silver	New Jersey
United States	Tri County Hematology & Oncology Associates, Inc Site Number : 8400012	Massillon	Ohio
United States	Millennium Oncology Site Number : 8400025	Pembroke Pines	Florida
United States	Comprehensive Hematology Oncology Site Number : 8400026	Saint Petersburg	Florida
United States	University of California San Francisco (PARENT) Site Number : 8400009	San Francisco	California
United States	Renovatio Clinical Site Number : 8400004	The Woodlands	Texas
United States	Prairie Lakes Health Care System, Inc Site Number : 8400002	Watertown	South Dakota
United States	Novant Health Forsyth Medical Center Site Number : 8400028	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  China,  France,  Germany,  Hong Kong,  Italy,  Japan,  Netherlands,  Puerto Rico,  Spain,  Switzerland,  Taiwan,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria	12 months
Primary	Progression free survival (PFS)	Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first.	up to 18 months
Primary	Progression free survival rate (PFSR)	The proportion of patients who do not progress and are alive at specific time intervals	up to 18 months
Primary	Duration of response (DoR)	Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR , VGPR , CR , or sCR to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first.	12 months
Primary	Time to response (TTR)	Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria	12 months
Primary	Time to first subsequent anti-myeloma therapy	Time from the initiation of isatuximab until the start of subsequent therapy or death.	30 months
Primary	Rate of very good partial response or better	Comprising VGPR, CR, and sCR within 12 months	up to 12 months
Primary	Rate of complete response (CR) or better	Comprising CR and sCR responses within 12 months	up to 12 months
Primary	Number of Participants with Adverse events	Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion	1 month after end of treatment
Primary	Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30)	The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact.	through end of treatment (up to approximately 2 years)
Primary	Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)	The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item).	through end of treatment (up to approximately 2 years)