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Evaluating maintenance therapy for newly diagnosed multiple myeloma patients

A Prospective, Observational Study, to Evaluate the 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 Autologous Stem Cell Transplantation (ASCT): Alcyone-optimized Real World Evidence (RWE) Data

Observational PETHEMA Foundation · NCT05218603

This study is testing if a combination of Bortezomib and Daratumumab can help newly diagnosed multiple myeloma patients who can't have a stem cell transplant feel better and stay healthy after their initial treatment.

Quick facts

Study typeObservational
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorPETHEMA Foundation Academic / other
Drugs / interventionsdaratumumab
Locations32 sites (Arganda Del Rey and 31 other locations)
Trial IDNCT05218603 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and safety of maintenance therapy with Bortezomib and Daratumumab (V-Dara) following induction treatment with Bortezomib, Melphalan, and Prednisone plus Daratumumab (VMP-Dara) in patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. Patients will be enrolled during routine clinical visits and followed for 3-4 years without any changes to their standard treatment. The study will document the outcomes of patients receiving this maintenance therapy as part of their regular clinical care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed multiple myeloma who have completed induction therapy with VMP-Dara and are not eligible for autologous stem cell transplantation.

Not a fit: Patients with conditions such as primary amyloidosis, smoldering multiple myeloma, or other specified hematological disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the long-term effectiveness of V-Dara maintenance therapy for patients with multiple myeloma who cannot undergo stem cell transplantation.

How similar studies have performed: While this approach is observational, similar studies have shown promising results in the management of multiple myeloma with maintenance therapies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Arganda Del Rey and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaNon-eligible for Autologous Stem Cell TransplantationProspectiveObservational study
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.