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

Recruiting

• Conditions: Multiple Myeloma; Autologous Stem Cell Transplantation; Leukapheresis; Daratumumab
• Interventions: Drug: Daratumumab

• Registration Number: NCT05835726
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-28
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases (prospective cohort)	Daratumumab	Patients who fulfill the inclusion criteria (newly diagnosed multiple myeloma patients undergoing daratumumab-containing induction regimens).

Primary Outcome Measures

Name	Time	Method
To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.	12 months	To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.

Secondary Outcome Measures

Name	Time	Method
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	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.
Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.	12 months	Proportion (%) of patients who received plerixafor rescue for poor mobilization 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	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.
Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.	12 months	Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.
To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.	12 months	To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS; 🇮🇹 Rome, Italy