Multiple Myeloma Clinical Trial

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

Summary

Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >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

View Full Description

Full Description

Duration per participant is 2.5 years

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

1200

Study ID:

NCT04458831

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 84 Locations for this study

See Locations Near You

Investigational Site Number 8400021
Little Rock Arkansas, 72205, United States
Investigational Site Number 8400009
San Francisco California, 94143, United States
Investigational Site Number 8400030
Fort Lauderdale Florida, 33308, United States
Investigational Site Number 8400007
Jacksonville Florida, 32204, United States
Investigational Site Number 8400023
Lakeland Florida, 33805, United States
Investigational Site Number 8400025
Pembroke Pines Florida, 33024, United States
Investigational Site Number 8400026
Saint Petersburg Florida, 33709, United States
Investigational Site Number 8400019
Garden City Kansas, 67846, United States
Investigational Site Number 8400031
Lewiston Maine, 04240, United States
Investigational Site Number 8400010
Farmington Hills Michigan, 48334, United States
Investigational Site Number 8400006
Bolivar Missouri, 65613, United States
Investigational Site Number 8400016
Kansas City Missouri, 64114, United States
Investigational Site Number 8400017
Freehold New Jersey, 07728, United States
Investigational Site Number 8400024
Howell New Jersey, 07731, United States
Investigational Site Number 8400018
Little Silver New Jersey, 07739, United States
Investigational Site Number 8400028
Winston-Salem North Carolina, 27103, United States
Investigational Site Number 8400015
Canton Ohio, 44708, United States
Investigational Site Number 8400012
Massillon Ohio, 44646, United States
Investigational Site Number 8400020
Charleston South Carolina, 29414, United States
Investigational Site Number 8400011
Greenville South Carolina, 29615, United States
Investigational Site Number 8400002
Watertown South Dakota, 57201, United States
Investigational Site Number 8400013
Houston Texas, 77030, United States
Investigational Site Number 8400004
The Woodlands Texas, 77380, United States
Investigational site number 0400002
Steyr , 4400, Austria
Investigational site number 0400003
Wien , 1220, Austria
Investigational site number 5600002
Sint-Niklaas , , Belgium
Investigational site number 2500007
Argenteuil , 95107, France
Investigational site number 2500006
Chambéry , 73000, France
Investigational site number 2500012
Essey-lès-Nancy , 54270, France
Investigational site number 2500013
Lille , 59037, France
Investigational site number 2500004
Montpellier , 34295, France
Investigational Site Number 2500009
Pessac , 33604, France
Investigational site number 2500008
Poitiers , 86000, France
Investigational site number 2500010
Reims , 51100, France
Investigational site number 2500001
Rouen , 76000, France
Investigational site number 2500005
Saint-Priest-en-Jarez , 42270, France
Investigational site number 2500003
Toulouse , 31059, France
Investigational site number 2500011
Vannes , 56007, France
Investigational Site Number 2760014
Aschaffenburg , 63739, Germany
Investigational Site Number 2760016
Aschaffenburg , 63739, Germany
Investigational Site Number 2760025
Bad Liebenwerda , 04924, Germany
Investigational Site Number 2760017
Baden-Baden , 76532, Germany
Investigational Site Number 2760020
Bamberg , 96052, Germany
Investigational Site Number 2760018
Bayreuth , 95445, Germany
Investigational Site Number 2760003
Berlin , 10117, Germany
Investigational Site Number 2760041
Berlin , 10437, Germany
Investigational Site Number 2760009
Berlin , 10715, Germany
Investigational Site Number 2760007
Donauwörth , 86609, Germany
Investigational site number 2760001
Dortmund , 44263, Germany
Investigational Site Number 2760002
Dresden , 01127, Germany
Investigational Site Number 2760035
Dresden , 01307, Germany
Investigational Site Number 2760010
Frankfurt , 60389, Germany
Investigational Site Number 2760037
Frankfurt , 60596, Germany
Investigational Site Number 2760015
Goslar , 38642, Germany
Investigational Site Number 2760012
Hanover , 30449, Germany
Investigational Site Number 2760013
Herrsching Am Ammersee , 82211, Germany
Investigational Site Number 2760034
Koeln , 50677, Germany
Investigational Site Number 2760026
Kulmbach , 95326, Germany
Investigational Site Number 2760008
Leipzig , 04289, Germany
Investigational Site Number 2760011
Magdeburg , 39104, Germany
Investigational Site Number 2760006
Muenchen , 81241, Germany
Investigational Site Number 2760021
Oldenburg , 26121, Germany
Investigational Site Number 2760036
Oldenburg , 26133, Germany
Investigational Site Number 2760040
Stolberg , 52222, Germany
Investigational Site Number 2760031
Weilheim , 82362, Germany
Investigational Site Number 2760019
Würzburg , 97080, Germany
Investigational Site Number 3800005
Bologna , 40138, Italy
Investigational Site Number 3800007
Brescia , 25123, Italy
Investigational Site Number 3800001
Napoli , 80131, Italy
Investigational Site Number 3800010
Treviso , , Italy
Investigational Site Number 3920010
Fukuoka , 815-8, Japan
Investigational Site Number 3920002
Kamogawa , 296-8, Japan
Investigational Site Number 3920007
Kashiwa , 277-8, Japan
Investigational Site Number 3920004
Minato-Ku , 105-8, Japan
Investigational Site Number 3920005
Okayama , 701-1, Japan
Investigational Site Number 3920009
Osaka , 543-8, Japan
Investigational Site Number 3920012
Sapporo , 003-0, Japan
Investigational Site Number 3920008
Shibukawa , 377-0, Japan
Investigational Site Number 3920006
Shibuya , 150-8, Japan
Investigational Site Number 3920003
Sunto-gun , 411-8, Japan
Investigational Site Number 3920011
Suwa , 392-8, Japan
Investigational Site Number 3920001
Yamagata-shi , 990-9, Japan
Investigational Site Number 5820001
Dordrecht , 3318A, Netherlands
Investigational Site Number 8400001
Hato Rey , 00917, Puerto Rico
Investigational Site Number 5760003
Baden , 5404, Switzerland
Investigational Site Number 5760001
Bern , 3010, Switzerland
Investigational Site Number 5760002
Zürich , 8063, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

1200

Study ID:

NCT04458831

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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