Main info

Identificatie:

HO506 - Cassiopeia Follow Up

Sponsor:

IFM

Working group party:

Myeloma

Age:

>= 18

Stadium:

Alle lijnen

Echelon:

Limited Site Selection

Included patients:

91

(of 130)

Active sites:

23

(of 29)

5 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 Cassiopeia

SAFETY ENDPOINTS
- Identify SPMs (Second Primary Malignancies) and their frequency

DESCRIPTIVE 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.

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals