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

NCT ID: NCT05835726

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 188 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-01-31

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.

Conditions

Multiple Myeloma; Daratumumab; Autologous Stem Cell Transplantation; Leukapheresis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Cases (prospective cohort)

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

Daratumumab

Intervention Type: DRUG

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.

Controls

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Darzalex

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciana Teofili

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, , Italy

Countries

Italy

Other Identifiers

5446

Identifier Type: -

Identifier Source: org_study_id