Myeloma MultipleFOCUSNCT07445438
Feasibility of a Multi-omics Platform for Hematological Malignancies
A study testing Multi-omics analyses and Functional tests in people with Myeloma Multiple and Chronic Leukemia, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial summary
This is a biological study based on a collaborative effort involving several Italian haematology centres (including the coordinating centre). The study will be conducted retrospectively and prospectively using bone marrow (BM) or peripheral blood (PB) samples, lymph node or tissue biopsies with metastatic involvement… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Myeloma Multiple, Chronic Leukemia, Acute Leukemia
- What is being tested?
- Multi-omics analyses and Functional tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient aged > 2 year old
- Retrospective study:
- Patients previously diagnosed with hematological malignancies
- Prospective study:
- Patients with clinical suspect of hematological malignancies requiring a diagnostic assessment using BM or PB samples, biopsies of lymph nodes or tissues with metastatic involvement, or other biological fluids (such as CSF, pathologic pleural effusion).
- Patients with clinical suspicion of R/R onco-hematological disorder, requiring a diagnostic assessment using BM aspirate/biopsy or biopsies of tissues with metastatic involvement including lymph nodes, liquor from lumbar puncture, tissue aspirate etc.
- Patients with blastic transformation from a chronic condition or suspect of R/R hematological disease requiring a diagnostic assessment using PB drawn, BM aspirate/biopsy, lymph nodes biopsies, or biopsies of tissues with metastatic involvement, including CSF from lumbar puncture, tissue aspirate, etc.
Who cannot join
- Age <2 year old
- Patient without a diagnosis of hematological malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Parma
Parma, PR, 43126
Giovanni Roti, +39 0521 702200, giovanni.roti@unipr.it
About this study
This is a biological study based on a collaborative effort involving several Italian haematology centres (including the coordinating centre). The study will be conducted retrospectively and prospectively using bone marrow (BM) or peripheral blood (PB) samples, lymph node or tissue biopsies with metastatic involvement, and other biological fluids, such as cerebrospinal fluid and pathological pleural effusion.
Read the detailed description
Concerning the prospective study, the samples will be collected in each participant center during routine diagnostic/relapse investigations. Samples will be sent to our laboratory as fresh or frozen.
Concerning the retrospective part, patients whose frozen samples have been previously received and stored at the THEC of UNIPR for routine diagnostic assessment or other research protocols will be enrolled in the current study.
The hematologic malignancies that will be evaluated in this project include all hematologic entities described in the WHO 2022 classification, such as acute (AML, ALL) or chronic (CLL, CML, HCL) leukemia, myeloproliferative or lymphoproliferative disorders (MF, PV, TE, CMML, NHL, HL), and myelodysplastic or myelodysplastic/myeloproliferative disorders.
- Conditions
- Myeloma Multiple, Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders, Lymphoproliferative Disorders, Myelodysplastic Disorders
- Being tested
- Multi-omics analyses, Functional tests
- Medical subject headings
- Multiple Myeloma, Myeloproliferative Disorders, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-omics analysesOther
The focus of our scientific approach is based on multi-omics analyses: NGS (Next Generation Sequencing analysis), Bulk Transcriptomics, Single-cell resolution, Single-cell transcriptomics and phosphoproteomics.
Functional testsBiological
Functional analyses will be performed on primary sample from each enrolled patient. Malignant cells are cultered and incubated with a specific library of drugs (300 drugs) at four different concentrations for 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Hematological malignancies | Other | Patients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders Receives: Other: Multi-omics analyses; Biological: Functional tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize multi-omics features of different hematological malignancies to identify disease biomarkers
This will be performed through the application of transcriptomics, phosphoproteomics, metabolomics, genomics, and other omics techniques.
Proportion of samples in which ≥1 candidate biomarker is identified through multi-omic assessment (NGS, RNA-seq/Nanostring, single-cell/CITE-seq or phospho-proteomic profiling), categorized by predefined levels of evidence (high/moderate/exploratory according to current guidelines, such as ESCAT (5)).
Measured: At baseline
Evaluate the anti-cancer activity of bioactive compounds and derivatives for functionally pharmacotyping the disease and build a nationally oriented multicenter DRP platform.
Ex vivo sensitivity to compounds/derivatives: proportion of samples showing ex vivo response to at least one class of compounds of the library according to predefined thresholds on Drug Sensitivity Score (DSS) and/or AUC/IC50. The thresholds are identified based on previous reports, database (e.g. FORALL, Genomic of Drug Sensitivity in Cancer), and internal validation on previous cases assessed in our chemogenomic platform. Additional metrics will include the mean number of active compounds per sample and further application of DSS distribution in the experimental cohort (sDSS, dDSS, zDSS).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start31 Mar 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Roti, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445438
- Sponsor's protocol ID
- 662/2024/TESS/UNIPR
- Acronym
- FOCUS
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Multi-omics Platform for Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07445438
- Acronym / sponsor ID
- FOCUS / 662/2024/TESS/UNIPR
- Conditions
- Myeloma Multiple, Chronic Leukemia, Acute Leukemia, Myeloproliferative Disorders, Lymphoproliferative Disorders, Myelodysplastic Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a biological study based on a collaborative effort involving several Italian haematology centres (including the coordinating centre). The study will be conducted retrospectively and prospectively using bone marrow (BM) or peripheral blood (PB) samples, lymph node or tissue biopsies with metastatic involvement, and other biological fluids, such as cerebrospinal fluid and pathological pleural effusion.
Detailed description
Concerning the prospective study, the samples will be collected in each participant center during routine diagnostic/relapse investigations. Samples will be sent to our laboratory as fresh or frozen.
Concerning the retrospective part, patients whose frozen samples have been previously received and stored at the THEC of UNIPR for routine diagnostic assessment or other research protocols will be enrolled in the current study.
The hematologic malignancies that will be evaluated in this project include all hematologic entities described in the WHO 2022 classification, such as acute (AML, ALL) or chronic (CLL, CML, HCL) leukemia, myeloproliferative or lymphoproliferative disorders (MF, PV, TE, CMML, NHL, HL), and myelodysplastic or myelodysplastic/myeloproliferative disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematological malignancies | Other | Other: Multi-omics analyses, Biological: Functional testsPatients with clinical suspect of hematological malignancies or Relapsed and Refractory (R/R) onco-hematological disorders |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged > 2 year old
- Retrospective study:
- Patients previously diagnosed with hematological malignancies
- Prospective study:
- Patients with clinical suspect of hematological malignancies requiring a diagnostic assessment using BM or PB samples, biopsies of lymph nodes or tissues with metastatic involvement, or other biological fluids (such as CSF, pathologic pleural effusion).
Key exclusion criteria (2 listed)
- Age <2 year old
- Patient without a diagnosis of hematological malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-omics analysesThe focus of our scientific approach is based on multi-omics analyses: NGS (Next Generation Sequencing analysis), Bulk Transcriptomics, Single-cell resolution, Single-cell transcriptomics and phosphoproteomics. | Other | Hematological malignancies |
| Functional testsFunctional analyses will be performed on primary sample from each enrolled patient. Malignant cells are cultered and incubated with a specific library of drugs (300 drugs) at four different concentrations for 72 hours. | Biological | Hematological malignancies |
Primary outcome
Characterize multi-omics features of different hematological malignancies to identify disease biomarkers
Time frame: At baseline
This will be performed through the application of transcriptomics, phosphoproteomics, metabolomics, genomics, and other omics techniques. Proportion of samples in which ≥1 candidate biomarker is identified through multi-omic assessment (NGS, RNA-seq/Nanostring, single-cell/CITE-seq or phospho-proteomic profiling), categorized by predefined levels of evidence (high/moderate/exploratory according to current guidelines, such as ESCAT (5)).
Evaluate the anti-cancer activity of bioactive compounds and derivatives for functionally pharmacotyping the disease and build a nationally oriented multicenter DRP platform.
Time frame: At baseline
Ex vivo sensitivity to compounds/derivatives: proportion of samples showing ex vivo response to at least one class of compounds of the library according to predefined thresholds on Drug Sensitivity Score (DSS) and/or AUC/IC50. The thresholds are identified based on previous reports, database (e.g. FORALL, Genomic of Drug Sensitivity in Cancer), and internal validation on previous cases assessed in our chemogenomic platform. Additional metrics will include the mean number of active compounds per sample and further application of DSS distribution in the experimental cohort (sDSS, dDSS, zDSS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-omics analyses and Functional tests in people with Myeloma Multiple and Chronic Leukemia, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Roti, Associate Professor (+39 0521 702200, giovanni.roti@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize multi-omics features of different hematological malignancies to identify disease biomarkers (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.