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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

NCT05218603 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-09-16

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Bortezomib

Maintenance: Administration as per routine clinical practice.

DRUG

Daratumumab

Maintenance: Administration as per routine clinical practice.

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Adknoma Health Research

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • María Victoria Mateos Manteca · Hospital Universitario de Salamanca (Salamanca)

  • Jesús San Miguel Izquierdo · Clínica Universidad de Navarra (Pamplona)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2025-11-06
Completion
2025-11-06

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218603 on ClinicalTrials.gov