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Trial Title:
Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients.
NCT ID:
NCT05835726
Condition:
Multiple Myeloma
Daratumumab
Autologous Stem Cell Transplantation
Leukapheresis
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Daratumumab
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Daratumumab
Description:
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.
Arm group label:
Cases (prospective cohort)
Other name:
Darzalex
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario A.Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luciana Teofili
Email:
luciana.teofili@unicatt.it
Investigator:
Last name:
Luciana Teofili
Email:
Principal Investigator
Start date:
January 1, 2022
Completion date:
April 30, 2024
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05835726
