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

First listed
Feb 1, 2022
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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