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Completed

NCT Number: NCT05835726

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

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.

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Key information

Conditions

Multiple Myeloma Autologous Stem Cell Transplantation Blood Protein Disorders Cardiovascular Diseases Daratumumab Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukapheresis Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Darzalex

Primary outcomes

  1. To assess the difference in the mean number of collected CD34+ cells/kg during total harvest between Daratumumab and control group.

    Time frame: 12 months

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

Secondary outcomes

  1. 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.

    Time frame: 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.

  2. Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.

    Time frame: 12 months

    Proportion (%) of patients who received plerixafor rescue for poor mobilization in Daratumumab versus control group.

  3. 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.

    Time frame: 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.

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

    Time frame: 12 months

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

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

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: DILEMMA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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