IFM HO506 MM
Main info
- Identificatie:
- HO506 - Cassiopeia Follow Up
- Sponsor:
- IFM
- Working group party:
- Myeloma
- Stadium:
- Alle lijnen
- Echelon:
- Limited Site Selection
- Active sites:
-
0(of 30)29 sites are pending
- Title:
The CASSIOPEIA Follow-Up Registry: Long-Term Follow up of patients from the CASSIOPEIA study IFM 2023-03: CASSIOPEIA-FU
Timeline
Details
- Phase:
- Observational Prospective
- Monitoring Type:
- Study Specific
- Objectives:
EFFICACY ENDPOINTS
Overall Survival (OS), including :
- OS from the first randomization of CASSIOPEIA to death due to any causes.
- OS from second randomization of CASSIOPEIA to death due to any causes.Progression Free Survival (PFS) per investigator assessment, including :
- PFS from the first randomization of Cassiopeia
- PFS from second randomization of Cassiopeia
- Progression Free Survival on the Next Line of Therapy (PFS2)
- PFS2 from the first randomization of Cassiopeia
- PFS2 from second randomization of CassiopeiaSAFETY ENDPOINTS
- Identify SPMs (Second Primary Malignancies) and their frequencyDESCRIPTIVE ENDPOINTS
- Identify subsequent anti-myeloma therapies
Eligibility
- Inclusion Criteria:
In order to be eligible to participate in this study, a patient must meet the following criteria:
- Adult patients (≥18 years) who participated in and completed the CASSIOPEIA study
- For patients from Belgium and the Netherlands : patients who signed an informed consent form (ICF) for the collection of their data in the CASSIOPEIA Follow-Up registry- Exclusion Criteria:
A patient from Belgium and the Netherlands who meets the following criterium cannot be included in this study:
- patients who did not receive CASSIOPEIA Follow-Up registry study information or who did not sign the ICF.