Multiple Myeloma Clinical Trial
A Prospective, 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
Full Description
Duration per participant is 2.5 years
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.
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There are 113 Locations for this study
Little Rock Arkansas, 72205, United States
Fullerton California, 92835, United States
San Francisco California, 94143, United States
Fort Lauderdale Florida, 33308, United States
Jacksonville Florida, 32204, United States
Lakeland Florida, 33805, United States
Pembroke Pines Florida, 33024, United States
Saint Petersburg Florida, 33709, United States
Garden City Kansas, 67846, United States
Garden City Kansas, 67846, United States
Lewiston Maine, 04240, United States
Watertown Massachusetts, 57201, United States
Farmington Hills Michigan, 48334, United States
Kansas City Missouri, 64114, United States
Freehold New Jersey, 07728, United States
Howell New Jersey, 07731, United States
Little Silver New Jersey, 07739, United States
Winston-Salem North Carolina, 27103, United States
Canton Ohio, 44708, United States
Massillon Ohio, 44646, United States
Charleston South Carolina, 29414, United States
Greenville South Carolina, 29615, United States
Houston Texas, 77030, United States
The Woodlands Texas, 77380, United States
Ciudad Autonoma de Buenos Aires Buenos Aires, C1181, Argentina
Cordoba , 5016, Argentina
Steyr , 4400, Austria
Wien , 1220, Austria
Brussels , 1000, Belgium
Sint Niklaas , 9100, Belgium
Shenzhen , 51805, China
Argenteuil , 95107, France
Chambéry , 73000, France
Essey les Nancy , 54270, France
Le Mans Cedex , 72037, France
Lille , 59037, France
Montpellier Cedex 5 , 34295, France
Pessac cedex , 33604, France
Poitiers , 86021, France
Reims , 51092, France
Rouen , 76038, France
Saint Priest En Jarez , 42270, France
Tarbes , 65013, France
Toulouse , 31059, France
Vannes Cedex , 56017, France
Aschaffenburg , 63739, Germany
Aschaffenburg , 63739, Germany
Bad Liebenwerda , 04924, Germany
Baden-Baden , 76532, Germany
Bamberg , 96052, Germany
Bayreuth , 95445, Germany
Berlin , 10117, Germany
Berlin , 10437, Germany
Berlin , 10715, Germany
Berlin , 12200, Germany
Donauwoerth , 86609, Germany
Dortmund , 44263, Germany
Dresden , 01127, Germany
Dresden , 01307, Germany
Frankfurt am Main , 60389, Germany
Frankfurt , 60596, Germany
Goslar , 38642, Germany
Hannover , 30449, Germany
Herrsching , 82211, Germany
Koeln , 50677, Germany
Kulmbach , 95326, Germany
Leipzig , 04289, Germany
Magdeburg , 39104, Germany
Marburg , 35037, Germany
Muenchen , 81241, Germany
Mutlangen , 73557, Germany
Oldenburg , 26121, Germany
Oldenburg , 26133, Germany
Potsdam , 14467, Germany
Stolberg , 52222, Germany
Weilheim , 82362, Germany
Wuerzburg , 97070, Germany
Hong Kong , , Hong Kong
Rome Roma, 00137, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Milan , 20132, Italy
Napoli , 80138, Italy
Novara , 28100, Italy
Treviso , 31100, Italy
Sapporo-shi Hokkaido, 003-0, Japan
Osaka-shi Osaka, 543-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Minato-ku Tokyo, 105-8, Japan
Shibuya-ku Tokyo, 150-8, Japan
Fukuoka-shi , 815-8, Japan
Kamogawa-shi , 296-8, Japan
Kashiwa-shi , 277-8, Japan
Minato-ku , 105-8, Japan
Okayama-shi , 701-1, Japan
Shibukawa-shi , 377-0, Japan
Suwa-shi , 392-8, Japan
Yamagata-shi , 990-9, Japan
Dordrecht , 3318 , Netherlands
Hato Rey , 00917, Puerto Rico
San Juan , 00917, Puerto Rico
Volgograd , 40013, Russian Federation
Leon León, 24071, Spain
Malaga Málaga, 29010, Spain
Pamplona Navarra, 31008, Spain
Granada , 18012, Spain
Palma de Mallorca , 07120, Spain
San Cristobal De La Laguna , 38320, Spain
Toledo , 45003, Spain
Baden , 5404, Switzerland
Bern , 3010, Switzerland
Zurich , 8063, Switzerland
Abu Dhabi , 11001, United Arab Emirates
Abu dhabi , 7400, United Arab Emirates
Nottingham Nottinghamshire, NG5 1, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Huddersfield , HD3 3, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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