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

Multiple Myeloma Clinical Trial

— DILEMMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835726
• Other study ID #: 5446
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Luciana Teofili
• Phone: +39 06 30154180
• Email: luciana.teofili[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: April 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autologous Stem Cell Transplantation
• Daratumumab
• Leukapheresis
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Daratumumab
NDMM (newly diagnosed multiple myeloma) who fulfill the inclusion criteria, candidate to stem cell mobilization, collection, and autologous stem cell transplant who receive a Daratumumab-containing induction regimen.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A.Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.	To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.	12 months
Secondary	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.	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.	12 months
Secondary	Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.	Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.	12 months
Secondary	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.	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.	12 months
Secondary	Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.	Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.	12 months
Secondary	To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.	To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.	12 months