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

Launched by PETHEMA FOUNDATION · Jan 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment plan for patients with newly diagnosed multiple myeloma (MM) who cannot receive an autologous stem cell transplant (ASCT). The treatment involves a regimen called VMP-Dara followed by maintenance therapy with V-Dara. The goal is to see how well this approach works over a period of 3 to 4 years, as patients continue their regular medical follow-up without any changes to their treatment due to being part of the study.

To be eligible for this trial, patients must be at least 18 years old and have recently been diagnosed with MM that does not qualify for ASCT. They should have already completed the initial treatment with VMP-Dara. Participants will have their health monitored by their doctors as usual, and they may stop taking the medications if they have side effects or for other medical reasons. It’s important for patients to understand that their participation in the trial will not alter their standard care, and they will still receive the best treatment available for their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Patients ≥18 years of age.
• • 3. 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 Criteria:
• • 1. 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.
• • 2. 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.