Genomic and Phenotypic Determinants of Resistance to Immunotherapies in Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03848676 |
Recruitment Status :
Active, not recruiting
First Posted : February 21, 2019
Last Update Posted : September 21, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Multiple Myeloma | Diagnostic Test: Evaluation of patients resistance to immunotherapies in Multiple Myeloma |
Study Type : | Observational |
Actual Enrollment : | 40 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Genomic and Phenotypic Determinants of Resistance to Immunotherapies in Multiple Myeloma |
Actual Study Start Date : | July 1, 2018 |
Estimated Primary Completion Date : | June 1, 2024 |
Estimated Study Completion Date : | July 1, 2024 |
- Diagnostic Test: Evaluation of patients resistance to immunotherapies in Multiple Myeloma
There are only collections of the samples.
- Sensitivity vs resistance to new immunotherapies [ Time Frame: 5 years ]The patients' response to new drugs administration will be evaluated identifying genomic aberrations (e.g. TRAF3 deletion/mutation and Cereblon mutation) or impaired cellular surface molecules expression (eg CD38, CD55, CD59 expression).
- Cell extrinsic mechanisms of response [ Time Frame: 5 years ]The analysis will include T-cells population (eg. CD38+, CD4+, CD8+, Tregs cells), regulatory and suppressive immune populations (MDSCs) and cytokines (eg Activin-A, IL-3, IL-6, RANKL, OPG, MIP-1α, MIP-3α and DKK-1) characterization.
- Biomarkers of response [ Time Frame: 5 years ]Response measured through cytofluorimetric analysis. Results will be integrated by statistical models (e.g. univariate, multivariate analysis) and then correlated to mutational results and patients' available clinical data in order to predict outcome.
- Biomarkers of response [ Time Frame: 5 years ]Response measured through mutational analysis. Results will be integrated by statistical models (e.g. univariate, multivariate analysis) and then correlated to cytofluorimetric results and patients' available clinical data in order to predict outcome.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- MM patients at clinical relapse who progressed during PIs or IMiDs-based therapies
- Patients assigned to antiCD38-based salvage treatments
- Patients with measurable disease
Exclusion Criteria:
- No criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848676
Italy | |
Dipartimento di Biotecnologie Molecolari e Scienze per la Salute | |
Torino, TO, Italy, 10126 |
Responsible Party: | Mario Boccadoro, Principal Investigator, University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT03848676 |
Other Study ID Numbers: |
IG-20541 |
First Posted: | February 21, 2019 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Immunotherapies Genomic Resistance |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Immunomodulating Agents Immunologic Factors Physiological Effects of Drugs |