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NCT05835726Completed

Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients.

Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients (DILEMMA).

Source: ClinicalTrials.gov · Last updated 15 Aug 2025

Brief summary (registry, in English)

Daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation (CD) 38, a cell surface protein that is overexpressed on multiple myeloma (MM) cells, showing significant activity in relapsed/refractory disease. More recently, it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant (ASCT) induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival. However, in consideration of the expression of CD38 antigen also by stem cells, daratumumab could exert effects on their mobilization, collection, and engraftment. The primary objective of this retrospective/prospective observational study is to investigate the impact of adding daratumumab to standard induction regimens (VTD:bortezomib-thalidomide and dexamethasone, VD: bortezomib and dexamethasone) on stem cell mobilization in patients with newly diagnosed multiple myeloma (NDMM) who are candidates for ASCT.

Status (registry)
Completed
Study type
Observational
Enrollment
188 (actual)
First submitted
19 Apr 2023
Start date
1 Jan 2022
Primary completion date
31 Jan 2025
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT05835726

What you commit to

  • Study type: Observational
  • Participants enrolled: 188
  • From 1 Jan 2022 to the primary completion date, 31 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients not proceeding to stem cell mobilization because of disease progression.

Age

  • Age \<18 y.o.

Other

  • Inability to obtain written informed consent.
  • Patients not eligible for high-dose cyclophosphamide according to baseline cardiologic evaluation.

Who the study is looking for

  • Age ≥ 18 years.
  • NDMM candidate to stem cell mobilization, collection, and ASCT who received a Daratumumab-containing induction regimen.
  • Signed written informed consent to study participation.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.