IFM HO506 MM

Gepland
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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

Scheduled
Actual
2024
01 feb.
Development
2024
22 mrt.
Opportunity
2024
13 mei
EC Approval
2024
28 jun.
EC Approval
2024
15 aug.
Submission in Progress
2024
30 sep.
First Site
2024
30 sep.
FPI
2027
01 mrt.
Endpoint Analysis

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

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Participating Sites

Site
29 results
Order by
Accrual rate
Activation date
BE-Roeselare-AZDELTA
NL-Amsterdam-VUMC
NL-Arnhem-RIJNSTATE
NL-Dordrecht-ASZ
NL-Deventer-DZ
NL-Ede-ZGV
NL-Hoofddorp-SPAARNEGASTHUIS
NL-Tilburg-ETZ
BE-Haine-Saint-Paul-JOLIMONT
NL-Leeuwarden-MCL
NL-Alkmaar-NWZ
NL-Sittard-Geleen-ZUYDERLAND
BE-Brugge-AZBRUGGE
NL-Utrecht-UMCUTRECHT
NL-Groningen-UMCG
NL-Nieuwegein-ANTONIUS
BE-Leuven-UZLEUVEN
BE-Antwerpen-ZNAMIDDELHEIM
NL-Breda-AMPHIA
NL-Rotterdam-ERASMUSMC
NL-Den Haag-HAGA
NL-Zwolle-ISALA
NL-Leiden-LUMC
NL-Maastricht-MUMC
NL-Eindhoven-MAXIMAMC
NL-Amersfoort-MEANDERMC
NL-Enschede-MST
NL-Amsterdam-OLVG
BE-Turnhout-AZSTELISABETH
= Active hospitals
= Inactive hospitals

Participating Parties

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