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

April 28, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A.Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases (prospective cohort)
Patients who fulfill the inclusion criteria (newly diagnosed multiple myeloma patients undergoing daratumumab-containing induction regimens).
Drug: 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.
Other Names:
  • Darzalex
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
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.
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.
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5446

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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