Primary Objectives:
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04270409 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sanofi |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Sciences & Operations |
Principal Investigator Affiliation | Sanofi |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Brazil, Canada, China, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, New Zealand, Norway, Poland, Spain, Sweden, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Plasma Cell Myeloma |
Study duration is expected to be approximately 12 years, including a 42-day screening period, followed by an up to 36-month treatment period, and a follow-up period of approximately 9 years.
Experimental: Isatuximab, lenalidomide, and dexamethasone (ILd)
Participants will receive isatuximab [intravenous (IV) administration] in combination with lenalidomide [per os (PO) administration] and dexamethasone [IV on Day 1 of Cycle 1 for participants receiving isatuximab IV only and PO otherwise for subsequent cycles] for 24 cycles followed by isatuximab monotherapy for 12 cycles for a total duration of 36 cycles. 1 cycle = 28 days
Active Comparator: Lenalidomide and dexamethasone (Ld)
Lenalidomide [PO administration] in combination with dexamethasone [PO administration] for 24 cycles. 1 cycle = 28 days
Drug: - Isatuximab SAR650984
Pharmaceutical for: Solution for infusion Route of administration: Intravenous
Drug: - Lenalidomide
Pharmaceutical form: Capsules Route of administration: Oral
Drug: - Dexamethasone
Pharmaceutical form: Tablets and solution for injection Route of administration: Oral and intravenous
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
UCLA-Site Number:8400010
Los Angeles, California, 90024
Status
Recruiting
Address
Colorado Blood Cancer Institute-Site Number:8400007
Denver, Colorado, 80218
Status
Recruiting
Address
Cancer Specialist of North Florida-Site Number:8400011
Jacksonville, Florida, 32256
Status
Recruiting
Address
University of Miami-Site Number:8400012
Miami, Florida, 33136
Status
Recruiting
Address
Dana Farber Cancer Institute-Site Number:8400001
Boston, Massachusetts, 02115
Status
Recruiting
Address
Presbyterian Hospital-Site Number:8400015
Charlotte, North Carolina, 28204
Status
Recruiting
Address
Novant Health Forsyth Medical Center-Site Number:8401015
Winston-Salem, North Carolina, 27103
Status
Recruiting
Address
Tennessee Oncology, PLLC-Site Number:8400006
Nashville, Tennessee, 37203
Status
Recruiting
Address
~University of Texas - MD Anderson Cancer Center-Site Number:8400002
Houston, Texas, 77030
Status
Active, not recruiting
Address
Investigational Site Number :0360008
Liverpool, New South Wales, 2170
Status
Active, not recruiting
Address
Investigational Site Number :0360005
Waratah, New South Wales, 2298
Status
Active, not recruiting
Address
Investigational Site Number :0360001
Wollongong, New South Wales, 2500
Status
Active, not recruiting
Address
Investigational Site Number :0360002
Fitzroy, Victoria, 3065
Status
Active, not recruiting
Address
Investigational Site Number :0360007
Heidelberg West, Victoria, 3081
Status
Active, not recruiting
Address
Investigational Site Number :0360004
Richmond, Victoria, 3121
Status
Active, not recruiting
Address
Investigational Site Number :0360006
Nedlands, Western Australia, 6009
Status
Active, not recruiting
Address
Investigational Site Number :0760002
Sao Paulo, São Paulo, 04537-081
Status
Active, not recruiting
Address
Investigational Site Number :1240004
Edmonton, Alberta, T6G 1Z2
Status
Active, not recruiting
Address
Investigational Site Number :1240005
Moncton, New Brunswick, E1C 6Z8
Status
Active, not recruiting
Address
Investigational Site Number :1240001
Montreal, Quebec, H1T 2M4
Status
Active, not recruiting
Address
Investigational Site Number :1560002
Hangzhou, , 310003
Status
Active, not recruiting
Address
Investigational Site Number :1560003
Hangzhou, , 310003
Status
Active, not recruiting
Address
Investigational Site Number :1560006
Nanchang, , 330006
Status
Active, not recruiting
Address
Investigational Site Number :1560004
Shanghai, , 200032
Status
Active, not recruiting
Address
Investigational Site Number :1560005
Shenyang, , 110022
Status
Active, not recruiting
Address
Investigational Site Number :1560001
Tianjin, , 300020
Status
Active, not recruiting
Address
Investigational Site Number :2080001
Aalborg, , 9000
Status
Active, not recruiting
Address
Investigational Site Number :2080003
Aarhus N, , 8200
Status
Active, not recruiting
Address
Investigational Site Number :2080005
Copenhagen, , 2100
Status
Active, not recruiting
Address
Investigational Site Number :2080002
Roskilde, , 4000
Status
Active, not recruiting
Address
Investigational Site Number :2500009
Ars-Laquenexy, , 57085
Status
Active, not recruiting
Address
Investigational Site Number :2500010
Bayonne, , 64109
Status
Active, not recruiting
Address
Investigational Site Number :2500007
GRENOBLE Cedex 9, , 38043
Status
Active, not recruiting
Address
Investigational Site Number :2500006
La Roche sur Yon, , 85925
Status
Active, not recruiting
Address
Investigational Site Number :2500003
Lille, , 59037
Status
Active, not recruiting
Address
Investigational Site Number :2500005
Paris, , 75012
Status
Active, not recruiting
Address
Investigational Site Number :2500011
Paris, , 75013
Status
Active, not recruiting
Address
Investigational Site Number :2500002
Poitiers Cedex, , 86021
Status
Active, not recruiting
Address
Investigational Site Number :2500001
RENNES Cedex 09, , 35033
Status
Active, not recruiting
Address
Investigational Site Number :2760001
Hamburg, , 20246
Status
Active, not recruiting
Address
Investigational Site Number :2760002
Heidelberg, , 69120
Status
Active, not recruiting
Address
Investigational Site Number :3000002
Athens, , 10676
Status
Active, not recruiting
Address
Investigational Site Number :3000001
Athens, , 11528
Status
Active, not recruiting
Address
Investigational Site Number :3000003
Thessaloniki, , PC 54007
Status
Active, not recruiting
Address
Investigational Site Number :3480003
Budapest, , 1083
Status
Active, not recruiting
Address
Investigational Site Number :3480001
Budapest, , 1097
Status
Active, not recruiting
Address
Investigational Site Number :3480002
Debrecen, , 4032
Status
Active, not recruiting
Address
Investigational Site Number :3480004
Kaposvár, , 7400
Status
Active, not recruiting
Address
Investigational Site Number :3720003
Dublin 7, Dublin,
Status
Active, not recruiting
Address
Investigational Site Number :3720002
Dublin 8, Dublin,
Status
Active, not recruiting
Address
Investigational Site Number :3720001
Dublin 9, Dublin,
Status
Active, not recruiting
Address
Investigational Site Number :3760004
Ashdod, , 7747629
Status
Active, not recruiting
Address
Investigational Site Number :3760001
Jerusalem, , 91031
Status
Active, not recruiting
Address
Investigational Site Number :3760002
Jerusalem, , 91120
Status
Active, not recruiting
Address
Investigational Site Number :3760005
Petah-Tikva, , 49100
Status
Active, not recruiting
Address
Investigational Site Number :3760006
Ramat Gan, , 5265601
Status
Active, not recruiting
Address
Investigational Site Number :3760003
Tel Aviv, , 64239
Status
Active, not recruiting
Address
Investigational Site Number :3800006
Meldola, Forlì-Cesena, 47014
Status
Active, not recruiting
Address
Investigational Site Number :3800001
Rozzano, Milano, 20089
Status
Active, not recruiting
Address
Investigational Site Number :3800005
Ancona, , 60032
Status
Active, not recruiting
Address
Investigational Site Number :3800003
Bologna, , 40138
Status
Active, not recruiting
Address
Investigational Site Number :3800002
Terni, , 05100
Status
Active, not recruiting
Address
Investigational Site Number :3920002
Nagoya-shi, Aichi, 467-8602
Status
Completed
Address
Investigational Site Number :3920006
Kamogawa-shi, Chiba, 296-8602
Status
Active, not recruiting
Address
Investigational Site Number :3920008
Maebashi-shi, Gunma, 371-8511
Status
Active, not recruiting
Address
Investigational Site Number :3920005
Higashiibaraki-gun, Ibaraki, 311-3193
Status
Active, not recruiting
Address
Investigational Site Number :3920003
Okayama-shi, Okayama, 701-1192
Status
Active, not recruiting
Address
Investigational Site Number :3920009
Sunto-gun, Shizuoka, 411-8777
Status
Active, not recruiting
Address
Investigational Site Number :3920001
Shibuya-ku, Tokyo, 150-8935
Status
Active, not recruiting
Address
Investigational Site Number :4100004
Gangnam-gu, Seoul-teukbyeolsi, 06351
Status
Active, not recruiting
Address
Investigational Site Number :4100003
Seoul, Seoul-teukbyeolsi, 03080
Status
Active, not recruiting
Address
Investigational Site Number :4100001
Seoul, Seoul-teukbyeolsi, 03722
Status
Active, not recruiting
Address
Investigational Site Number :4100002
Seoul, , 06591
Status
Active, not recruiting
Address
Investigational Site Number :4400001
Vilnius, , 08661
Status
Active, not recruiting
Address
Investigational Site Number :5540004
Christchurch, Canterbury,
Status
Active, not recruiting
Address
Investigational Site Number :5540001
Hamilton, Waikato, 3204
Status
Active, not recruiting
Address
Investigational Site Number :5780002
Bergen, , 5021
Status
Active, not recruiting
Address
Investigational Site Number :5780001
Oslo, , 0450
Status
Active, not recruiting
Address
Investigational Site Number :6160006
Bydgoszcz, Kujawsko-pomorskie, 85-168
Status
Active, not recruiting
Address
Investigational Site Number :6160002
Lodz, Lódzkie, 93-510
Status
Active, not recruiting
Address
Investigational Site Number :6160008
Gdansk, Pomorskie, 80-214
Status
Active, not recruiting
Address
Investigational Site Number :6160005
Chorzow, Slaskie, 41-500
Status
Active, not recruiting
Address
Investigational Site Number :7240004
Barcelona, Barcelona [Barcelona], 08036
Status
Active, not recruiting
Address
Investigational Site Number :7240001
Barcelona, Barcelona [Barcelona], 08041
Status
Active, not recruiting
Address
Investigational Site Number :7240006
Pamplona, Navarra, 31008
Status
Active, not recruiting
Address
Investigational Site Number :7240002
Valencia, Valenciana, Comunidad, 46017
Status
Active, not recruiting
Address
Investigational Site Number :7240005
Madrid, , 28041
Status
Active, not recruiting
Address
Investigational Site Number :7240007
Salamanca, , 37007
Status
Active, not recruiting
Address
Investigational Site Number :7240003
Zaragoza, , 50009
Status
Active, not recruiting
Address
Investigational Site Number :7520001
Göteborg, , 413 45
Status
Active, not recruiting
Address
Investigational Site Number :7520003
Helsingborg, , 251 87
Status
Active, not recruiting
Address
Investigational Site Number :8260002
Bournemouth, Hampshire, BH7 7DW
Status
Active, not recruiting
Address
Investigational Site Number :8260003
London, London, City Of, SE1 7EH
Status
Active, not recruiting
Address
Investigational Site Number :8260001
Leicester, , LE15WW
Status
Active, not recruiting
Address
Investigational Site Number :8260004
Southampton, , SO16 6YD