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

NCT05835726 | Completed

• 1 other identifier: 5446
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 who received plerixafor rescue for poor mobilization in Daratumumab versus control group.

  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.

  12 months

• Rate (%) of CD38 expression and clonogenic potential of collected CD34+ cells in both groups.

  12 months

• To compare transplant outcome in term of time (days) to platelets and neutrophils engraftment in Daratumumab versus control group.

  12 months

Study Arms (2)

Cases (prospective cohort)

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

Drug: Daratumumab

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.

Interventions

Daratumumab 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.

Also known as: Darzalex

Cases (prospective cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Luciana Teofili

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: April 28, 2023
• Study Start: January 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-01

Locations

IT (1)