A Study to Evaluate Safety, Pharmacokinetics, and Activity of Cevostamab as Monotherapy and Cevostamab Plus Pomalidomide and Dexamethasone or Cevostamab Plus Daratumumab and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (CAMMA 1)

2023-507019-36-00 Protocol GO42552 Human pharmacology (Phase I) - Other Ongoing, recruitment ended

Start 8 Jul 2022 · Status Ongoing, recruitment ended · 6 EU/EEA countries · 13 sites · Protocol GO42552

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruitment ended
Participants planned 138
Countries 6
Sites 13

Relapsed or Refractory Multiple Myeloma (R/R MM)

Key facts

Sponsor
Genentech Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
8 Jul 2022 → ongoing
Decision date (initial)
2024-08-30
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-507019-36-00
EudraCT number
2021-000238-33

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Relapsed or Refractory Multiple Myeloma (R/R MM)

VersionLevelCodeTermSystem organ class
21.0 LLT 10028228 Multiple myeloma 10029104

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genentech Inc.

35 Total trials 8 Recruiting 25 Ended
Commercial
Sponsor organisation
Genentech Inc.
Address
1 Dna Way
City
South San Francisco
Postcode
94080-4918
Country
United States

Scientific contact point

Organisation
Genentech Inc.
Contact name
US Program Manager Product Development Regulatory

Public contact point

Organisation
Genentech Inc.
Contact name
US Program Manager Product Development Regulatory

Locations

6 EU/EEA countries · 13 investigational sites

By country

CountryMS statusPlanned subjectsSites
Czechia Ongoing, recruitment ended 11 2
Denmark Ongoing, recruitment ended 3 1
France Ongoing, recruitment ended 11 3
Italy Ongoing, recruitment ended 6 2
Poland Ongoing, recruitment ended 9 3
Spain Ongoing, recruitment ended 10 2
Rest of world
Japan, Israel, United States, Canada, Russian Federation, Korea, Republic of, Australia, United Kingdom
 — 88 —

Investigational sites

Czechia

2 sites · Ongoing, recruitment ended
Vseobecna Fakultni Nemocnice V Praze
I. Interni klinika, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava

Denmark

1 site · Ongoing, recruitment ended
Rigshospitalet
Hæmatologisk klinik, Blegdamsvej 9, 2100, Copenhagen Oe

France

3 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire De Poitiers
Service Oncologie Hématologique et Thérapie Cellulaire / Centre d’investigation clinique, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Saint Louis
Service Immuno-Hématologie / Centre d’investigation clinique, 1 Avenue Claude Vellefaux, 75010, Paris
Hospital Hotel Dieu
Service d’Hématologie, 1 Place Alexis Ricordeau, 44000, Nantes

Italy

2 sites · Ongoing, recruitment ended
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. di Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
UOC Ematologia, Piazza Oms 1, 24127, Bergamo

Poland

3 sites · Ongoing, recruitment ended
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice

Spain

2 sites · Ongoing, recruitment ended
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Czechia 2022-07-08 2022-07-11 2024-12-10
Denmark 2022-11-01 2024-03-20 2024-12-10
France 2023-10-26 2024-05-15 2024-12-10
Italy 2022-09-15 2023-08-22 2024-12-10
Poland 2023-08-11 2023-08-29 2024-12-10
Spain 2022-10-20 2023-08-21 2024-12-10

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-15 Italy Acceptable
2024-08-27
 2024-08-27
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-10-07 Italy Acceptable
2024-08-27
 2024-10-07
3 NON SUBSTANTIAL MODIFICATION NSM-2 2024-10-16 Italy Acceptable
2024-08-27
 2024-10-16
4 SUBSTANTIAL MODIFICATION SM-1 2024-12-03 Acceptable 2025-01-09
5 SUBSTANTIAL MODIFICATION SM-2 2025-03-31 Italy Acceptable
2025-07-03
 2025-07-03
6 NON SUBSTANTIAL MODIFICATION NSM-3 2025-08-06 Italy Acceptable
2025-07-03
 2025-08-06
7 NON SUBSTANTIAL MODIFICATION NSM-4 2025-09-15 Italy Acceptable
2025-07-03
 2025-09-15
8 NON SUBSTANTIAL MODIFICATION NSM-5 2025-09-29 Italy Acceptable
2025-07-03
 2025-09-29
9 NON SUBSTANTIAL MODIFICATION NSM-6 2025-10-30 Italy Acceptable
2025-07-03
 2025-10-30
10 SUBSTANTIAL MODIFICATION SM-3 2025-10-31 Italy Acceptable 2025-12-18

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