Status:
UNKNOWN
Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT
Lead Sponsor:
PETHEMA Foundation
Collaborating Sponsors:
Janssen, LP
Adknoma Health Research
Conditions:
Multiple Myeloma
Non-eligible for Autologous Stem Cell Transplantation (ASCT)
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, observational, single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnose...
Detailed Description
This is a prospective, observational, single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnose...
Eligibility Criteria
Inclusion
- Patients with a newly diagnosed MM non eligible for ASCT that have received induction therapy with D-VMP (9 cycles) and followed by V-Dara as maintenance\* in clinical practice. The decision to prescribe maintenance treatment with V-Dara must be in accordance with clinical practice, must not be influenced by the planned inclusion of a patient in the study, and should be documented before enrollment.
- Patients ≥18 years of age.
- Each subject (or their legally acceptable representative) must sign the ICF indicating that he or she understands the purpose of the observational nature the study and are willing to share his/her clinical data for the study.
Exclusion
- Patients with a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering MM, plasma cell leukemia, POEMS syndrome, Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- Subjects with prior or current systemic therapy or ASCT for MM (before VMP-Dara induction), except for an emergency use of a short course of corticosteroids before treatment.
Key Trial Info
Start Date :
November 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 6 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05218603
Start Date
November 30 2021
End Date
November 6 2025
Last Update
September 16 2022
Active Locations (32)
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1
Hospital Universitario Del Sureste
Arganda, Spain
2
Complejo Asistencial de Avila
Ávila, Spain
3
Hospital Quirón Sagrado Corazón
Barcelona, Spain
4
Hsopital Clinic de Barcelona
Barcelona, Spain