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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Autologous Stem Cell Transplantation; Multiple Myeloma; Daratumumab; Leukapheresis

Treatments: Drug: Daratumumab

Study type: Observational

Funder types: Other

Identifiers

NCT05835726

5446

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

188 participants in 2 patient groups

Cases (prospective cohort)

Description:

Patients who fulfill the inclusion criteria (newly diagnosed multiple myeloma patients undergoing daratumumab-containing induction regimens).

Treatment:

Drug: Daratumumab

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.