Clinical trial NCT05835726: Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients.
Official title: Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients (DILEMMA).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Daratumumab
Autologous Stem Cell Transplantation
Leukapheresis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases (prospective cohort): Patients with newly diagnosed multiple myeloma candidate to stem cell mobilization, collection, and autologous stem cell transplant who receive a Daratumumab-containing induction regimen.

Controls: Patients with newly diagnosed multiple myeloma who received standard VTD 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: Proportion (%) of patients achieving at least two minimum transplant doses (4x10^6 CD34+ cells/kg) at first day of apheresis in Daratumumab versus control group.
timeFrame: 12 months
measure: Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.
timeFrame: 12 months
measure: Graft composition in Daratumumab group in term of concentration of CD34+ cells x10^6/kg, TNC (total nucleated cells) x 10^8/kg, and MNC (mononuclear cells) x 10^8/kg.
timeFrame: 12 months
measure: Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.
timeFrame: 12 months
measure: To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Luciana Teofili
role: PRINCIPAL_INVESTIGATOR
References: