Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Stem Cell Transplantation | — | UNRESOLVED | — |
| Daratumumab | — | UNRESOLVED | — |
| Leukapheresis | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Cases (prospective cohort)
- description
- Patients who fulfill the inclusion criteria (newly diagnosed multiple myeloma patients undergoing daratumumab-containing induction regimens).
- interventionNames
- Drug: Daratumumab
- label
- Controls
- description
- Patients with newly diagnosed multiple myeloma who received standard VTD (VTD:bortezomib-thalidomide and dexamethasone) induction, subsequent stem cell mobilization, and tandem autologous stem cell transplant before the introduction of daratumumab in our local practice from January 2020 to December 2021.
Primary outcomes (1)
- measure
- To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.
- timeFrame
- 12 months
- description
- To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Age \<18 y.o. * Inability to obtain written informed consent. * Patients not proceeding to stem cell mobilization because of disease progression. * Patients not eligible for high-dose cyclophosphamide according to baseline cardiologic evaluation.
References
Publications (0)
Data not yet available