A study to evaluate the Safety, Pharmacokinetics, and Activity of Subcutaneous Cevostamab (BFCR4350A) in Patients with Relapsed or Refractory Multiple Myeloma (CAMMA 3)

2023-503404-89-00 Protocol GO43227 Human pharmacology (Phase I) - Other Ongoing, recruiting

Start 8 Dec 2021 · Status Ongoing, recruiting · 3 EU/EEA countries · 6 sites · Protocol GO43227

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ongoing, recruiting
Participants planned 80
Countries 3
Sites 6

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 Dec 2021 → ongoing
Decision date (initial)
2024-07-30
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-503404-89-00
EudraCT number
2021-002307-36

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Relapsed or Refractory Multiple Myeloma R/R MM

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
94080-4990
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

3 EU/EEA countries · 6 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 12 2
Greece Ongoing, recruiting 20 2
Italy Ongoing, recruiting 13 2
Rest of world
Australia, Canada, Korea, Republic of
 — 35 —

Investigational sites

Belgium

2 sites · Ongoing, recruiting
UZ Brussel
Hematology, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent

Greece

2 sites · Ongoing, recruiting
Evangelismos S.A.
Hematology Clinic, Ipsiladou 45-47, 106 76, Athens
Alexandra Hospital
Athens Medical School - Therapeutic Clinic, Vassilissas Sofias Avenue 80, 115 28, Athens

Italy

2 sites · Ongoing, recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O. di Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Humanitas Mirasole S.p.A.
U.O di Oncologia Medica ed Ematologia accreditata fase I, Via Alessandro Manzoni 56, 20089, Rozzano

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 2022-06-22 2022-12-27
Greece 2021-12-08 2022-01-04
Italy 2022-05-12 2023-01-09

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-08 Belgium Acceptable with conditions
2024-07-30
 2024-07-30
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-10-24 Belgium Acceptable with conditions
2024-07-30
 2024-10-24
3 NON SUBSTANTIAL MODIFICATION NSM-2 2024-10-25 Belgium Acceptable with conditions
2024-07-30
 2024-10-25
4 SUBSTANTIAL MODIFICATION SM-1 2025-04-01 Belgium Acceptable
2025-06-30
 2025-07-01
5 NON SUBSTANTIAL MODIFICATION NSM-3 2025-08-06 Belgium Acceptable
2025-06-30
 2025-08-06
6 NON SUBSTANTIAL MODIFICATION NSM-4 2025-10-30 Belgium Acceptable
2025-06-30
 2025-10-30
7 NON SUBSTANTIAL MODIFICATION NSM-5 2026-01-28 Acceptable
2025-06-30
 2026-01-28
8 SUBSTANTIAL MODIFICATION SM-2 2026-02-12 Belgium Acceptable
2026-03-25
 2026-03-25

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