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

Sponsor
PETHEMA Foundation
Study ID
NCT05218603
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Maintenance: Administration as per routine clinical practice.
  • Daratumumab — DRUG
    Maintenance: Administration as per routine clinical practice.

Study Details

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 diagnosed MM patients who are not eligible for ASCT. Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice (screening and enrollment visit) and followed during 3-4 years in what will be called the Observational Phase. During this phase, the patient will be followed by his/her doctor as per routine clinical practice, according to his/her disease. The patient will not suffer any changes in his/her treatment or follow-up due to his/her participation in the study. The patient will receive standard clinical practice and he/she will not do any other study-specific visit. During this 3-4-year observational phase, the patient might discontinue V or V-Dara,depending on toxicity, efficacy or due to other medical reasons, according to his/her physician decision.

Key Dates

Start date
Nov 30, 2021
Status verified
Sep 2022
Primary completion
Nov 6, 2025
Completion
Nov 6, 2025

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Maintenance with V-Dara after receiving VMP-Dara as induction regimen
    Maintenance with bortezomib plus daratumumab (V-Dara) after induction with bortezomib, melphalan, prednisone plus daratumumab (VMP-Dara)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Throughout the study period. Approximately 4 years ]

Central Contacts

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