A study to investigate safety and efficacy with SAR445514 in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light-chain amyloidosis (RRLCA)

2022-502057-33-00 Protocol TCD17710 Phase I and Phase II (Integrated) - First administration to humans Ended

Start 2 Oct 2023 · End 27 May 2025 · Status Ended · 6 EU/EEA countries · 16 sites · Protocol TCD17710

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - First administration to humans
Status Ended
Participants planned 104
Countries 6
Sites 16

Relapsed/refractory multiple myeloma

Key facts

Sponsor
Sanofi-Aventis Recherche & Developpement
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
2 Oct 2023 → 27 May 2025
Decision date (initial)
2023-06-20
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes

External identifiers

EU CT number
2022-502057-33-00
WHO UTN
U1111-1279-2985

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Relapsed/refractory multiple myeloma

VersionLevelCodeTermSystem organ class
23.0 LLT 10083938 Amyloid light-chain amyloidosis 10021428
25.0 LLT 10086466 Relapsed/refractory multiple myeloma 100000004848

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

111 Total trials 43 Recruiting 63 Ended
Commercial
Sponsor organisation
Sanofi-Aventis Recherche & Developpement
Address
82 Avenue Raspail
City
Gentilly
Postcode
94250
Country
France

Scientific contact point

Organisation
Sanofi-Aventis Research & Development
Contact name
Clinical Sciences and Operations

Public contact point

Organisation
Sanofi-Aventis Research & Development
Contact name
Clinical Sciences and Operations

Locations

6 EU/EEA countries · 16 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 7 4
Czechia Ended 11 2
Greece Ended 4 1
Hungary Ended 11 3
Italy Ended 13 2
Spain Ended 13 4
Rest of world
Australia, United States, United Kingdom, China, Japan
 — 45 —

Investigational sites

Belgium

4 sites · Ended
Het Ziekenhuisnetwerk Antwerpen
Hematology department, Lindendreef 1, 2020, Antwerp
Het Ziekenhuisnetwerk Antwerpen
Hematology department, Kempenstraat 100, 2030, Antwerp
Institut Jules Bordet
Hematology department, Mijlenmeersstraat 90, 1070, Brussels
Het Ziekenhuisnetwerk Antwerpen
Hematology department, Lange Beeldekensstraat 267, 2060, Antwerp

Czechia

2 sites · Ended
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Klinika Hematoonkologie, 17. Listopadu 1790/5, 708 00, Poruba

Greece

1 site · Ended
Alexandra Hospital
Department of clinical therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens

Hungary

3 sites · Ended
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
2. sz. Hematológiai részleg, Albert Florian Ut 5-7, 1097, Budapest IX
Semmelweis University
Belgyógyászati és Onkológiai Klinika Klinikai Farmakológiai Részleg, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII

Italy

2 sites · Ended
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Dipartimento di Oncologia, S.C. di Ematologia, Corso Bramante 88, 10126, Turin
Humanitas Research Hospital
Unità di Fase I -Humanitas Cancer Center, Via Alessandro Manzoni 56, 20089, Rozzano

Spain

4 sites · Ended
Catalan Institute Of Oncology
Hematologia, Carretera Canyet S/n, 08916, Badalona
Hospital Clinic De Barcelona
Hematologia, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Marques De Valdecilla
Hematologia, 5 Planta, Avenida Valdecilla S/n, Santander

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2023-12-11 2023-12-11 2025-03-03
Hungary 2023-10-26 2023-10-26 2025-03-03
Italy 2024-01-24 2024-01-24 2025-03-03
Spain 2023-10-02 2023-10-02 2025-03-03

Application history

15 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-03-06 Spain Acceptable
2023-06-15
 2023-06-15
2 SUBSTANTIAL MODIFICATION SM-1 2023-06-27 Acceptable 2023-09-11
3 SUBSTANTIAL MODIFICATION SM-2 2023-06-27 Spain Acceptable 2023-07-11
4 SUBSTANTIAL MODIFICATION SM-3 2023-06-27 Acceptable 2023-08-02
5 SUBSEQUENT ADDITION OF MSC APP-5 2023-07-04 2023-09-26
6 SUBSEQUENT ADDITION OF MSC APP-6 2023-07-04 2023-09-21
7 SUBSTANTIAL MODIFICATION SM-4 2023-10-02 Acceptable 2023-11-07
8 SUBSEQUENT ADDITION OF MSC APP-8 2023-10-05 2024-01-12
9 SUBSTANTIAL MODIFICATION SM-5 2024-02-16 Spain Acceptable
2024-05-16
 2024-05-16
10 NON SUBSTANTIAL MODIFICATION NSM-2 2024-05-29 Spain Acceptable
2024-05-16
 2024-05-29
11 SUBSTANTIAL MODIFICATION SM-6 2024-07-08 Spain Acceptable with conditions
2024-10-01
 2024-10-01
12 NON SUBSTANTIAL MODIFICATION NSM-3 2024-12-11 Spain Acceptable with conditions
2024-10-01
 2024-12-11
13 NON SUBSTANTIAL MODIFICATION NSM-4 2025-03-04 Spain Acceptable with conditions
2024-10-01
 2025-03-04
14 NON SUBSTANTIAL MODIFICATION NSM-5 2025-05-09 Spain Acceptable with conditions
2024-10-01
 2025-05-09
15 NON SUBSTANTIAL MODIFICATION NSM-6 2025-05-21 Spain Acceptable with conditions
2024-10-01
 2025-05-21

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