Clinical trial • Phase I • Oncology

JNJ-79635322 for Multiple myeloma

Phase I trial of JNJ-79635322 for Multiple myeloma. 68 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Multiple myeloma
Trial Stage
Phase I
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
22-08-2024
First CTIS Authorization Date
16-12-2024

Trial design

Phase I trial across 5 sites in Netherlands, Spain.

Target Sample Size
68

Eligibility

Recruits 68 The CTIS record indicates isVulnerablePopulationSelected = true, but no further details on the vulnerable population, consent or assent handling are provided in the available documents..

Vulnerable Population
The CTIS record indicates isVulnerablePopulationSelected = true, but no further details on the vulnerable population, consent or assent handling are provided in the available documents.

Recruitment

Planned Sample Size
68
Recruitment Window Months
38
Consent Approach
Not specified in the provided CTIS record; no details on informed consent/assent process, age-specific documents or available languages are provided.

Geography

Total Number Of Sites
5
Total Number Of Participants
32

Netherlands

Earliest CTIS Part Ii Submission Date
04-12-2024
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
471
Number Of Sites
3
Number Of Participants
22

Sites

Site Name
Stichting Amsterdam UMC
Department Name
Hematology
Contact Person Name
Niels van de Donk
Contact Person Email
hematology@amsterdamumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Hematology
Contact Person Name
Wouter Plattel
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Hematology
Contact Person Name
Monique Minnema
Contact Person Email
hemat-research@umcutrecht.nl

Spain

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
494
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Hospital Universitario De Salamanca
Department Name
Ensayos Clinicos de Hematología
Contact Person Name
Maria Victoria Mateos
Contact Person Email
mvmateos@usal.es
Site Name
Hospital Clinic De Barcelona
Department Name
Hematología
Contact Person Name
Laura Rosiñol
Contact Person Email
lrosinol@clinic.cat

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
JNJ-79635322
Active Substance
JNJ-79635322
Investigational Product Name
Daratumumab
Active Substance
Daratumumab
Modality
Monoclonal antibody
Investigational Product Name
Lenalidomide
Active Substance
Lenalidomide
Modality
Small molecule
Investigational Product Name
Pomalidomide
Active Substance
Pomalidomide
Modality
Small molecule
Combination Treatment
Yes

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