Multicentre Phase III trial in patients with relapsed multiple myeloma
Background
A Phase III clinical trial in multiple myeloma was conducted in haematology to evaluate an innovative treatment in patients with relapsed multiple myeloma.
The primary objective was to improve overall survival and to assess the tolerability of the treatment compared with standard supportive care, in a complex and heavily pretreated population.
Challenges identified
The challenges of a Phase III clinical trial in multiple myeloma
Pharmaspecific’s role
Pharmaspecific handled the regulatory submissions, coordinated clinical trial agreement management and provided monitoring in France, ensuring a fast study start-up and full compliance with Good Clinical Practice (GCP). These activities contributed to the smooth running of the multiple myeloma clinical trial, in particular through rigorous organisation of regulatory and operational activities.
Indicators & Results
Key takeaways
This project illustrates the ability of Pharmaspecific to:
Explore our clinical case studies
- Oncology
- Haematology
- Virology
- Rare diseases
- Cardiology
- Medical devices
Supporting a multicentre oncology study
Setting up patient expense management and coordinating investigator sites for an international study.
- Multicentre observational study on optimising the oncology care pathway.
- Phase II clinical trial (paediatric oncology) — CINV prevention
- Phase II clinical trial in thoracic oncology in a targeted population with a rare molecular alteration
- National real-world data (RWD) centralisation project in oncology
Strengthening monitoring for an international trial
A dedicated CRA team to ensure data quality across several countries
- Multicentre Phase III trial in patients with relapsed multiple myeloma
- International Phase III clinical trial comparing a new molecule combined with rituximab with standard treatment in lymphomas.
- Bioequivalence clinical study in haematology in around twenty patients, comparing a new generic with the reference molecule
Securing the launch of a vaccine trial
Coordinated regulatory submissions in 6 countries simultaneously
Facilitating recruitment for an orphan disease
A patient concierge service to reduce the burden on a geographically dispersed population
Preparing for a regulatory inspection with confidence
An independent GCP audit to anticipate deviations before inspection
Bringing an implantable device into MDR compliance
Comprehensive regulatory support, from strategy to submission
