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
- Contact Person Email
- trialbureauhematologie@onco.umcg.nl
- 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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