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
- Diseases
- Multiple myeloma
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.