NCT03848676Completed
Genomic and Phenotypic Determinants of Resistance to Immunotherapies in Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
A total of 40 Multiple Myeloma (MM) patients at clinical relapse who progressed during Proteasome Inhibitors (PIs) or Immunomodulating Drugs (IMiDs)-based therapies and who are assigned to antiCD38-based salvage treatments, will be enrolled. We will collect bone marrow (BM) and peripheral blood (PB) samples from patients at specific timepoints: * baseline (BM, PB and buccal swab) * every 3 month (PB) * achievement of response (≥ Very Good Partial Response (VGPR)) (BM and PB) * relapse or refractory status to antiCD38-based treatments (BM and PB) Samples will be processed and stored in the "Hematological Laboratory" located in the University of Turin (Italy) for various proposed analyses: at specific time-points CD138+ (Plasma Cells-PCs) and marker CD138/19+ (B cells) will be immunomagnetically enriched from the BM mononuclear cells and frozen as viable cells in dimethyl sulfoxide (DMSO); PB mononuclear cells (PBMCs) will be isolated from whole blood by density-gradient centrifugation, and frozen as above; plasma fraction from PB and BM will be obtained by centrifugation and stored frozen; a buccal swab will be obtained at the time of enrollment as a source of control germline DNA and stored frozen.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 14 Dec 2018
- Start date
- 1 Jul 2018
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- University of Turin, Italy
- Diseases
- Multiple myeloma
- NCT number
- NCT03848676
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 1 Jul 2018 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- No criteria
Who the study is looking for
- MM patients at clinical relapse who progressed during PIs or IMiDs-based therapies
- Patients assigned to antiCD38-based salvage treatments
- Patients with measurable disease
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dipartimento di Biotecnologie Molecolari e Scienze per la Salute Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.