- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04458831
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (IONA-MM)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Trial Transparency email recommended (Toll free number for US & Canada)
- Phone Number: option 6 800-633-1610
- Email: Contact-US@sanofi.com
Study Locations
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Cordoba, Argentina, 5016
- Recruiting
- Investigational Site Number : 0320002
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
- Recruiting
- Investigational Site Number : 0320001
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Steyr, Austria, 4400
- Recruiting
- LKH Steyr - Investigational Site Number : 0400002
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Contact:
- Hanns HAUSER
- Phone Number: +43505546624210
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Principal Investigator:
- Hanns HAUSER
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Wien, Austria, 1220
- Recruiting
- Investigational Site Number : 0400003
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Anderlecht, Belgium, 1070
- Recruiting
- Institut Jules Bordet - Investigational Site Number : 0560001
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Contact:
- Meuleman
- Phone Number: +3225413728
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Principal Investigator:
- Nathalie Meuleman
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Sint Niklaas, Belgium, 9100
- Recruiting
- Investigational Site Number : 0560002
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Shenzhen, China, 518053
- Recruiting
- Investigational Site Number : 1560001
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Argenteuil, France, 95107
- Recruiting
- Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007
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Contact:
- Emanuelle LE RAY
- Phone Number: +33134231566
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Principal Investigator:
- Emanuelle LE RAY
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Cahors, France, 46000
- Recruiting
- Investigational Site Number : 2500017
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Chambéry, France, 73000
- Recruiting
- Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006
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Contact:
- Pierre FAURI
- Phone Number: +33479965105
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Principal Investigator:
- Pierre FAURI
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Essey les Nancy, France, 54270
- Recruiting
- Investigational Site Number : 2500012
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Le Mans Cedex, France, 72037
- Recruiting
- Centre Hospitalier Le Mans - Investigational Site Number : 2500015
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Contact:
- Laribi Kamel
- Phone Number: +33255463467
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Principal Investigator:
- Laribi Kamel
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Lille, France, 59800
- Recruiting
- Investigational Site Number : 2500013
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Montpellier Cedex 5, France, 34295
- Recruiting
- Investigational Site Number : 2500004
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Pessac cedex, France, 33604
- Recruiting
- Investigational Site Number : 2500009
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Poitiers, France, 86021
- Recruiting
- CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008
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Contact:
- Xavier LEULEU
- Phone Number: +33549444201
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Principal Investigator:
- Xavier LEULEU
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Reims, France, 51092
- Recruiting
- CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010
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Contact:
- Sophie GODET
- Phone Number: +33326783644
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Principal Investigator:
- Sophie GODET
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Rouen, France, 76038
- Recruiting
- Investigational Site Number : 2500001
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Saint Priest En Jarez, France, 42270
- Recruiting
- Investigational Site Number : 2500005
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Saint Quentin cedex, France, 02321
- Recruiting
- Investigational Site Number : 2500014
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Tarbes, France, 65013
- Recruiting
- Investigational Site Number : 2500016
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Toulouse, France, 31059
- Withdrawn
- Investigational Site Number : 2500003
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Vannes Cedex, France, 56017
- Recruiting
- Investigational Site Number : 2500011
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Aschaffenburg, Germany, 63739
- Recruiting
- Investigational Site Number : 2760014
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Aschaffenburg, Germany, 63739
- Recruiting
- Investigational Site Number : 2760016
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Bad Liebenwerda, Germany, 04924
- Recruiting
- Investigational Site Number : 2760025
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Baden-Baden, Germany, 76532
- Recruiting
- Investigational Site Number : 2760017
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Bamberg, Germany, 96052
- Recruiting
- Investigational Site Number : 2760020
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Bayreuth, Germany, 95445
- Recruiting
- Investigational Site Number : 2760018
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Berlin, Germany, 10117
- Recruiting
- Investigational Site Number : 2760003
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Berlin, Germany, 10437
- Recruiting
- Investigational Site Number : 2760041
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Berlin, Germany, 10715
- Recruiting
- Investigational Site Number : 2760009
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Berlin, Germany, 12200
- Recruiting
- Investigational Site Number : 2760022
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Donauwoerth, Germany, 86609
- Recruiting
- Investigational Site Number : 2760007
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Dortmund, Germany, 44263
- Recruiting
- Investigational Site Number : 2760001
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Dresden, Germany, 01127
- Recruiting
- Investigational Site Number : 2760002
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Dresden, Germany, 01307
- Recruiting
- Investigational Site Number : 2760035
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Frankfurt, Germany, 60596
- Recruiting
- Investigational Site Number : 2760037
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Frankfurt am Main, Germany, 60389
- Recruiting
- Investigational Site Number : 2760010
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Goslar, Germany, 38642
- Recruiting
- Investigational Site Number : 2760015
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Hannover, Germany, 30449
- Recruiting
- Investigational Site Number : 2760012
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Herrsching, Germany, 82211
- Recruiting
- Investigational Site Number : 2760013
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Koeln, Germany, 50677
- Recruiting
- MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034
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Contact:
- Tilman Steinmetz
- Phone Number: +4922109318220
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Principal Investigator:
- Tilman Steinmetz
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Kulmbach, Germany, 95326
- Recruiting
- Investigational Site Number : 2760026
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Leipzig, Germany, 04289
- Recruiting
- Investigational Site Number : 2760008
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Magdeburg, Germany, 39104
- Recruiting
- Investigational Site Number : 2760011
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Marburg, Germany, 35037
- Recruiting
- Investigational Site Number : 2760038
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Muenchen, Germany, 81241
- Recruiting
- Investigational Site Number : 2760006
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Mutlangen, Germany, 73557
- Recruiting
- Investigational Site Number : 2760042
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Neubrandenburg, Germany, 17036
- Recruiting
- Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044
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Contact:
- Hemmati
- Phone Number: +493957753303
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Principal Investigator:
- Philipp Hemmati
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Oldenburg, Germany, 26121
- Recruiting
- Investigational Site Number : 2760021
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Oldenburg, Germany, 26133
- Recruiting
- Investigational Site Number : 2760036
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Potsdam, Germany, 14467
- Recruiting
- Investigational Site Number : 2760039
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Stolberg, Germany, 52222
- Recruiting
- Investigational Site Number : 2760040
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Weilheim, Germany, 82362
- Recruiting
- Investigational Site Number : 2760031
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Wuerzburg, Germany, 97070
- Recruiting
- Investigational Site Number : 2760019
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Hong Kong, Hong Kong
- Recruiting
- Investigational Site Number : 3440001
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Bologna, Italy, 40138
- Recruiting
- Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005
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Principal Investigator:
- Michele CAVO
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Contact:
- Michele CAVO
- Phone Number: +390512143810
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Brescia, Italy, 25123
- Recruiting
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007
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Principal Investigator:
- Angelo Belotti
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Contact:
- Angelo Belotti
- Phone Number: +39303996520
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Milan, Italy, 20132
- Recruiting
- Investigational Site Number : 3800003
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Napoli, Italy, 80138
- Recruiting
- Investigational Site Number : 3800001
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Novara, Italy, 28100
- Recruiting
- Investigational Site Number : 3800008
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Treviso, Italy, 31100
- Recruiting
- Investigational Site Number : 3800010
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Roma
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Rome, Roma, Italy, 00137
- Recruiting
- Investigational Site Number : 3800002
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Rome, Roma, Italy, 00133
- Recruiting
- Investigational Site Number : 3800009
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Fukuoka-shi, Japan, 815-8555
- Recruiting
- Investigational Site Number : 3920010
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Kamogawa-shi, Japan, 296-8602
- Withdrawn
- Investigational Site Number : 3920002
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Kashiwa-shi, Japan, 277-8567
- Withdrawn
- Investigational Site Number : 3920007
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Minato-ku, Japan, 105-8471
- Recruiting
- Investigational Site Number : 3920013
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Okayama-shi, Japan, 701-1192
- Recruiting
- Investigational Site Number : 3920005
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Osakasayama-shi, Japan, 589-8511
- Recruiting
- Investigational Site Number : 3920014
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Shibukawa-shi, Japan, 377-0280
- Recruiting
- Investigational Site Number : 3920008
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Suwa-shi, Japan, 392-8510
- Recruiting
- Investigational Site Number : 3920011
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Yamagata-shi, Japan, 990-9585
- Recruiting
- Investigational Site Number : 3920001
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Hokkaido
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Sapporo-shi, Hokkaido, Japan, 003-0006
- Recruiting
- Investigational Site Number : 3920012
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Osaka
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Osaka-shi, Osaka, Japan, 543-8555
- Recruiting
- Investigational Site Number : 3920009
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Shizuoka
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Sunto-gun, Shizuoka, Japan, 411-8777
- Recruiting
- Investigational Site Number : 3920003
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Tokyo
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Minato-ku, Tokyo, Japan, 105-8470
- Recruiting
- Investigational Site Number : 3920004
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Shibuya-ku, Tokyo, Japan, 150-8935
- Withdrawn
- Investigational Site Number : 3920006
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Kuwait, Kuwait, 42262
- Recruiting
- Investigational Site Number : 4140001
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Dordrecht, Netherlands, 3318 AT
- Recruiting
- Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001
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Principal Investigator:
- Mark-David LEVIN
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Contact:
- Mark-David LEVIN
- Phone Number: +31786523787
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Hato Rey, Puerto Rico, 00917
- Recruiting
- Puerto Rico Medical Research Center, LLC Site Number : 8400001
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San Juan, Puerto Rico, 00917
- Recruiting
- Auxilio Mutuo Cancer Center Site Number : 8400029
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Volgograd, Russian Federation, 400138
- Recruiting
- Investigational Site Number : 6430006
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Jeddah, Saudi Arabia, 23431 6688
- Recruiting
- Investigational Site Number : 6820004
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Khobar, Saudi Arabia, 34234
- Recruiting
- Investigational Site Number : 6820001
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Granada, Spain, 18012
- Recruiting
- Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010
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Principal Investigator:
- Maria Esther Clavero Sanchez
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Contact:
- Maria Esther Clavero Sanchez
- Phone Number: +34958020000
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Palma de Mallorca, Spain, 07120
- Recruiting
- Hospital Universitari Son Espases - Investigational Site Number : 7240003
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Principal Investigator:
- Antonia Sampol Mayol
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Contact:
- Antonia Sampol Mayol
- Phone Number: +34871206268
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Pontevedra, Spain, 36001
- Recruiting
- Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011
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Principal Investigator:
- Ana Maria Dios Loureiro
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Contact:
- Ana Maria Dios Loureiro
- Phone Number: +34986800399
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San Cristobal De La Laguna, Spain, 38320
- Recruiting
- omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007
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Principal Investigator:
- Sunil Lakhwani
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Contact:
- Sunil Lakhwani
- Phone Number: +34922678033
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Toledo, Spain, 45003
- Recruiting
- Investigational Site Number : 7240004
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León
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Leon, León, Spain, 24071
- Recruiting
- Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005
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Principal Investigator:
- Fernando Escalante Barrigon
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Contact:
- Fernando Escalante Barrigon
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Málaga
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Malaga, Málaga, Spain, 29010
- Recruiting
- Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006
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Principal Investigator:
- Maria Magdalena Alcala Pena
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Contact:
- Maria Magdalena Alcala Pena
- Phone Number: +34951290000
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Navarra
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Pamplona, Navarra, Spain, 31008
- Recruiting
- Investigational Site Number : 7240009
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Baden, Switzerland, 5404
- Recruiting
- Investigational Site Number : 5760003
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Bern, Switzerland, 3010
- Recruiting
- Investigational Site Number : 5760001
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Zürich, Switzerland, 8063
- Recruiting
- Investigational Site Number : 5760002
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Kaohsiung, Taiwan, 833401
- Recruiting
- Investigational Site Number : 1580002
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Abu Dhabi, United Arab Emirates, 11001
- Recruiting
- Investigational Site Number : 7840002
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Abu dhabi, United Arab Emirates, 7400
- Recruiting
- Investigational Site Number : 7840001
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Huddersfield, United Kingdom, HD3 3EA
- Recruiting
- Investigational Site Number : 8260004
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
- Recruiting
- Freeman Hospital - Investigational Site Number : 8260003
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Contact:
- Jennifer Young
- Phone Number: +441912336161
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Principal Investigator:
- Jennifer Young
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
- Recruiting
- Investigational Site Number : 8260002
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Recruiting
- Investigational Site Number : 8260005
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Arkansas
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Little Rock, Arkansas, United States, 72205-7199
- Recruiting
- University of Arkansas Medical Sciences Site Number : 8400021
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California
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Fullerton, California, United States, 92835
- Recruiting
- St. Joseph Heritage Healthcare Site Number : 8400008
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San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco (PARENT) Site Number : 8400009
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Recruiting
- Holy Cross Hospital Site Number : 8400030
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Jacksonville, Florida, United States, 32204
- Recruiting
- GenesisCare Site Number : 8400007
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Lakeland, Florida, United States, 33805
- Recruiting
- Watson Clinic Cancer and Research Center Site Number : 8400023
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Pembroke Pines, Florida, United States, 33024
- Recruiting
- Millennium Oncology Site Number : 8400025
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Saint Petersburg, Florida, United States, 33709
- Recruiting
- Comprehensive Hematology Oncology Site Number : 8400026
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Kansas
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Garden City, Kansas, United States, 67846
- Recruiting
- Central Care Cancer Center Site Number : 8400006
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Garden City, Kansas, United States, 67846
- Recruiting
- Central Care Cancer Center Site Number : 8400019
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Maine
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Lewiston, Maine, United States, 04240
- Recruiting
- Central Maine Medical Center Site Number : 8400031
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Michigan
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Farmington Hills, Michigan, United States, 48334
- Recruiting
- Michigan Center of Medical Research Site Number : 8400010
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Missouri
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Kansas City, Missouri, United States, 64114
- Recruiting
- AMR Kansas City Site Number : 8400016
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New Jersey
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Freehold, New Jersey, United States, 07728
- Recruiting
- Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017
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Howell, New Jersey, United States, 07731
- Recruiting
- Regional Cancer Care Associates Site Number : 8400024
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Little Silver, New Jersey, United States, 07739
- Recruiting
- Regional Cancer Care Associates - Little Silver Division Site Number : 8400018
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Novant Health Forsyth Medical Center Site Number : 8400028
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Ohio
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Canton, Ohio, United States, 44708
- Recruiting
- Hematology & Oncology Associates Site Number : 8400015
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Massillon, Ohio, United States, 44646
- Recruiting
- Tri County Hematology & Oncology Associates, Inc Site Number : 8400012
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South Carolina
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Charleston, South Carolina, United States, 29414
- Recruiting
- Charleston Hematology Oncology Associates, PA Site Number : 8400020
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Greenville, South Carolina, United States, 29615
- Recruiting
- Prisma Health - Eastside Office Site Number : 8400011
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South Dakota
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Watertown, South Dakota, United States, 57201-1548
- Recruiting
- Prairie Lakes Health Care System, Inc Site Number : 8400002
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Texas
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Houston, Texas, United States, 77030-4000
- Recruiting
- MD Anderson Cancer Center Site Number : 8400013
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The Woodlands, Texas, United States, 77380
- Recruiting
- Renovatio Clinical Site Number : 8400004
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort 1
Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
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Pharmaceutical form: solution for infusion Route of administration: intravenous
Other Names:
Pharmaceutical form: oral
Other Names:
Pharmaceutical form: oral
Pharmaceutical form: solution for infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: 12 months
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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
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12 months
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Progression free survival (PFS)
Time Frame: up to 18 months
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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.
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up to 18 months
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Progression free survival rate (PFSR)
Time Frame: up to 18 months
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The proportion of patients who do not progress and are alive at specific time intervals
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up to 18 months
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Duration of response (DoR)
Time Frame: 12 months
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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.
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12 months
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Time to response (TTR)
Time Frame: 12 months
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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
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12 months
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Time to first subsequent anti-myeloma therapy
Time Frame: 30 months
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Time from the initiation of isatuximab until the start of subsequent therapy or death.
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30 months
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Rate of very good partial response or better
Time Frame: up to 12 months
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Comprising VGPR, CR, and sCR within 12 months
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up to 12 months
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Rate of complete response (CR) or better
Time Frame: up to 12 months
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Comprising CR and sCR responses within 12 months
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up to 12 months
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Number of Participants with Adverse events
Time Frame: 1 month after end of treatment
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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
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1 month after end of treatment
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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)
Time Frame: through end of treatment (up to approximately 2 years)
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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.
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through end of treatment (up to approximately 2 years)
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Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)
Time Frame: through end of treatment (up to approximately 2 years)
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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).
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through end of treatment (up to approximately 2 years)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Pomalidomide
Other Study ID Numbers
- OBS16577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plasma Cell Myeloma
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Mayo ClinicNational Cancer Institute (NCI)CompletedRefractory Plasma Cell Myeloma | DS Stage I Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
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National Cancer Institute (NCI)CompletedRefractory Plasma Cell Myeloma | DS Stage I Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
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Emory UniversityNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; National Institutes...CompletedRefractory Plasma Cell Myeloma | Recurrent Plasma Cell Myeloma | ISS Stage III Plasma Cell Myeloma | ISS Stage II Plasma Cell Myeloma | ISS Stage I Plasma Cell MyelomaUnited States
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Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedRefractory Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell Myeloma | DS (Durie/Salmon) Stage I Plasma Cell MyelomaUnited States
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Albert Einstein College of MedicineNational Cancer Institute (NCI)CompletedRefractory Plasma Cell Myeloma | DS Stage I Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRefractory Plasma Cell Myeloma | DS Stage I Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedRefractory Plasma Cell Myeloma | DS Stage I Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
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National Cancer Institute (NCI)WithdrawnRefractory Plasma Cell Myeloma | DS Stage I Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
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National Cancer Institute (NCI)CompletedRefractory Plasma Cell Myeloma | DS Stage II Plasma Cell Myeloma | DS Stage III Plasma Cell MyelomaUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedRefractory Plasma Cell Myeloma | Recurrent Plasma Cell Myeloma | Plasma Cell LeukemiaUnited States
Clinical Trials on isatuximab SAR650984
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SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
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SanofiCompleted
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SanofiCompletedPlasma Cell MyelomaUnited States, Czechia, France
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SanofiCompleted
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Thomas Martin, MDWithdrawnRefractory Multiple Myeloma | Relapsed Multiple Myeloma
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SWOG Cancer Research NetworkNational Cancer Institute (NCI)Active, not recruitingNausea | Constipation | Diarrhea | Purpura | Lymphadenopathy | Gastrointestinal Hemorrhage | Hepatomegaly | Primary Systemic Amyloidosis | Amorphous, Eosinophilic, and Acellular Deposit | Early Satiety | Macroglossia | Recurrent Primary Amyloidosis | Refractory Primary AmyloidosisUnited States
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SanofiCompletedPlasma Cell MyelomaFrance, Italy, Czechia, Greece, Spain, Canada, Australia, United States, Brazil, Hungary
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingSmoldering Plasma Cell MyelomaUnited States
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SanofiTerminatedProstate Cancer | Non-small Cell Lung CancerTaiwan, United States, France, Italy, United Kingdom
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SanofiTerminatedLymphomaKorea, Republic of, Portugal, France, Taiwan, Italy, Netherlands, Spain