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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Tracking Information | |||||
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First Submitted Date | December 14, 2018 | ||||
First Posted Date | February 21, 2019 | ||||
Last Update Posted Date | September 21, 2023 | ||||
Actual Study Start Date | July 1, 2018 | ||||
Estimated Primary Completion Date | June 1, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Genomic and Phenotypic Determinants of Resistance to Immunotherapies in Multiple Myeloma | ||||
Official Title | Genomic and Phenotypic Determinants of Resistance to Immunotherapies in Multiple Myeloma | ||||
Brief Summary | 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:
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Detailed Description | Aim 1: Evaluation of cell-intrinsic mechanisms on BM.
Aim 2: Evaluation of cell-extrinsic mechanism on BM and PB.
Aim 3: After comprehensively characterizing the genomic, transcriptomic and immunophenotypic features of CD138+ cells, and having a clear picture of the effector/suppressive immune population in MM, we will then correlate these features with clinical data. In detail, we will create a database including the following columns:
Although the relatively small size of the cohort will limit statistical power and the possibility to perform subgroup analysis, this attempt to identify biomarkers could improve the clinical management of the patient, by prioritizing the vast array of salvage treatments in MM and thus decreasing costs. |
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Peripheral blood and bone marrow.
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Sampling Method | Non-Probability Sample | ||||
Study Population | MM patients at clinical relapse who progressed during PIs or IMiDs-based therapies and who are assigned to antiCD38-based salvage treatments | ||||
Condition | Multiple Myeloma | ||||
Intervention | Diagnostic Test: Evaluation of patients resistance to immunotherapies in Multiple Myeloma
There are only collections of the samples.
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Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
40 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 1, 2024 | ||||
Estimated Primary Completion Date | June 1, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Italy | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03848676 | ||||
Other Study ID Numbers | IG-20541 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Mario Boccadoro, University of Turin, Italy | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | University of Turin, Italy | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | University of Turin, Italy | ||||
Verification Date | September 2023 |