Multiple MyelomaNCT06338150
Precision Medicine Study
An observational study of Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (total n=100; approximately 50/year). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 9 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is open to interested patients with Multiple Myeloma (MM) of all genders and races from inside or outside Mount Sinai that will be undergoing tumor sampling (bone marrow or tissue) as part of their evaluation for salvage therapy. The research team will accept participants with a diagnosis of MM who self-refer, or are referred by their treating physician, who will be undergoing tumor biopsy (bone marrow or tissue) with the intention of receiving salvage systemic therapy for their MM. Interested individuals can contact the research team and learn more about the study. Potential participants would speak to one of the study staff over the phone, will be provided with further details about the study, pre-screened for eligibility, and set up to undergo informed consent.
Who may be able to join
- Patients must be 18 years of age at the time of registration.
- Participant must have an established diagnosis of relapsed Multiple Myeloma based on IMWG criteria, be willing to participate, and able to consent
- Participant must have a treating physician who agrees to participate in the study
- Participant will be undergoing a bone marrow biopsy or tumor biopsy as part of their standard of care.
- Patients must be willing to participate in this study and able to sign informed consent.
- Participants are not participating in any interventional clinical trial using systemic therapy directed towards control of MM.
Who cannot join
- Known diagnosis of AL amyloidosis, Waldenstrom Macroglobulinemia, POEMS, or Castleman´s disease.
- Diagnosis of cancer other than myeloma or skin cancer (squamous cell or basal cell) that is ongoing or treated within the last 2 years.
- Tumor sample inadequate or unavailable for analysis (e.g., due to insufficient number of tumor cells).
- Patient will not be receiving systemic MM-directed chemotherapy/immunotherapy in the following 2 months from the time tumor biopsy is performed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Sequencing Guided Personalized and Precision Medicine Platform in Multiple Myeloma
This will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (total n=100; approximately 50/year). Participants who will undergo tumor biopsy for management of multiple myeloma (MM) will self-refer to the study or be referred by their treating physician. Participants will initially meet with a clinician to review study consents and provide medical, medication, and family history information. After informed consent, biospecimen samples from peripheral blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF analysis). CS data will be interpreted via somatic variation identification, network modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes to networks and for identifying genes activated or dysregulated in cancer cells. Technologies and methodologies are developing rapidly, varying on a near daily basis which pre-empts our ability to define analysis and interpretation techniques in detail. Sequencing and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain types of analysis (e.g., a technology that is not yet available at Mount Sinai), de-identified samples or data may be sent out to third parties for additional analysis.. All external genetic tests will be performed in a CLIA certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive NYS Department of Health (Wadsworth Center) approval before results are provided to physicians . Samples will be de-identified and processed by the Mount Sinai Human Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for sequencing and analysis. Interpretation will be performed by a multidisciplinary team that includes genomicists, pathologists, and clinicians familiar with the particular cancer diagnosed in the participant. Once results are available, they will be shared with the study team. This study is not intended to implement the findings on CS, only to report the results obtained to the study team.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Multiple Myeloma | Participants who will undergo tumor biopsy for management of multiple myeloma (MM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of somatic Single-nucleotide variants (SNVs) per patient
The number of genetic alterations found in the genome through genetic sequencing and comparison to the most common genetic sequence. A given variant may describe an alteration that is benign, pathogenic, or of unknown significance.
Measured: End of study at 30 months
Secondary outcomes (25)
Total number of somatic insertions (INS) per patient
Total number of somatic insertions (INS) per patient. The number of instances where nucleotides have been erroneously added to the genome, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Total number of somatic deletions (DEL) per patient
The number of instances where nucleotides that have been erroneously omitted from the genome, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Number of SNVs per megabase of the MM genome
The number of genetic alterations detected in MM tumor cells through sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Number of INS per megabase of the MM genome
The number of instances where nucleotides have been erroneously added to the MM tumor genome, per length of DNA, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Number of DEL per megabase of the MM genome
The number of instances where nucleotides that have been erroneously omitted from the MM tumor genome, per length of DNA, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Number of mutations per megabase among MM subgroups
The number of genetic alterations detectable in >1 % or <1 % of the population, per length of DNA, among multiple myeloma (MM) subgroups, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Number of mutations per megabase among genomic regions for all MM and mutational subgroups
The number of genetic alterations detectable in >1 % or <1 % of the population, per length of DNA, by genetic region (i.e., promoter, coding region, and termination sequence), for all MM and mutational subgroups, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Gene mutations identified
The number and type of genetic alterations detectable in >1 % or <1 % of the population identified, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Chromosomal abnormalities identified
. The numbers and types of chromosomal abnormalities identified, as determined by genetic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
Molecular signatures identified
Number and type of sets of biomolecular features identified that could be useful in predicting the course of disease or response to therapeutic intervention among patients with MM and other cancers, as determined by sequencing, and gene set variation and targeted drug analysis.
Measured: End of study at 30 months
Established Prognostic markers identified
The number and type of established prognostic markers identified. Evaluation of biological characteristics known to be useful in predicting the course of disease or response to therapeutic intervention among patients with MM and other cancers, as determined by sequencing and comparison to databases of known prognostic markers.
Measured: End of study at 30 months
Somatic variants identified as targets of FDA-approved drugs (pharmacogenomics variant data)
The number and type of genetic alterations found in the genome that could be treated with FDA-approved therapies, as determined by sequencing and comparison to databases of known targets and associated FDA-approved drugs.
Measured: End of study at 30 months
Network-informed key driver variants identified
Number and type of mutations known to lead to cancer cell transformation, growth, and spread in the body, as determined by genetic sequencing and comparison to the most common genetic sequence, and to databases of known cancer driver mutations. These mutations will be categorized as follows: those that are known targets of FDA-approved drugs, those that may be targets of drugs under development that are not yet FDA-approved, and those that may serve as targets for novel therapies.
Measured: End of study at 30 months
Transcriptome variations identified
Number and type of transcriptome variations identified with potential for the development of novel therapeutics (cell-surface expressed proteins that appear amenable to vaccine development), as determined by sequencing, network modeling, and cancer transcriptome profiling.
Measured: End of study at 30 months
Germline mutations identified in cancer predisposition genes
Number and type of germline mutations identified in cancer predisposition genes, as determined by genomic sequencing and comparison to the most common genetic sequence.
Measured: End of study at 30 months
FDA approved drugs available that block enzymes produced in those pathways identified
The number and type of FDA-approved drugs available that block enzymes produced in those pathways identified by comparison of genomic and transcriptomic findings to databases of known FDA-approved drugs and associated targets.
Measured: End of study at 30 months
Treatment recommended by computational pipeline based on patient's clinical and genetic
A listing of recommended treatments as determined by sequencing, analysis of the tumor microenvironment, and computational analysis.
Measured: End of study at 30 months
Germline whole exome sequencing profile
The results of whole exome sequencing of the germline genome.
Measured: End of study at 30 months
Tumor genome whole exome sequencing profile
The results of whole exome sequencing of the tumor genome.
Measured: End of study at 30 months
Tumor transcriptome profile
The results of RNA sequencing of the tumor transcriptome.
Measured: End of study at 30 months
Single-cell sequencing profile
The results of single cell sequencing analysis.
Measured: End of study at 30 months
Cytometric profile
The results of the cytometry by time of flight (CyTOF) analysis.
Measured: End of study at 30 months
Signaling Pathways associated
Signaling Pathways associated with each gene mutation, chromosomal abnormality and molecular signature, i.e. aging, defective DNA repair, and apolipoprotein B editing complex (APOBEC)/activation-induced deaminase activity, identified in Aim 1, as determined by sequencing and computational analysis.
Measured: End of study at 30 months
Enzymes associated with each signaling pathway identified
Enzymes associated with each signaling pathway identified as determined by sequencing and computational analysis.
Measured: End of study at 30 months
Improvement of cancer sequencing-guided treatment recommendations by machine learning
Use of artificial intelligence computing to implement cancer sequencing-based recommended therapies and improve accuracy of treatment prediction, to allow better interpretation of cancer sequencing data and advancement of the development of personalized and precision cancer therapies. Improvement will be measured by tracking the precision and accuracy of machine learning and evaluating the resulting data using statistical analysis.
Measured: End of study at 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start17 Jul 2024
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Cesar Rodriguez Valdes, Icahn School of Medicine at Mount Sinai
- Investigators
- Cesar Rodriguez Valdes, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338150
- Sponsor's protocol ID
- STUDY-23-00503
- Other IDs
- GCO 19-0175, 5R01CA244899
- Status last verified
- Jun 2026
- First submitted
- 23 Mar 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Sequencing Guided Personalized and Precision Medicine Platform in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06338150
- Acronym / sponsor ID
- STUDY-23-00503
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 29 Mar 2024 (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 will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (total n=100; approximately 50/year). Participants who will undergo tumor biopsy for management of multiple myeloma (MM) will self-refer to the study or be referred by their treating physician. Participants will initially meet with a clinician to review study consents and provide medical, medication, and family history information. After informed consent, biospecimen samples from peripheral blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF analysis). CS data will be interpreted via somatic variation identification, network modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes to networks and for identifying genes activated or dysregulated in cancer cells. Technologies and methodologies are developing rapidly, varying on a near daily basis which pre-empts our ability to define analysis and interpretation techniques in detail. Sequencing and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain types of analysis (e.g., a technology that is not yet available at Mount Sinai), de-identified samples or data may be sent out to third parties for additional analysis.. All external genetic tests will be performed in a CLIA certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive NYS Department of Health (Wadsworth Center) approval before results are provided to physicians . Samples will be de-identified and processed by the Mount Sinai Human Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for sequencing and analysis. Interpretation will be performed by a multidisciplinary team that includes genomicists, pathologists, and clinicians familiar with the particular cancer diagnosed in the participant. Once results are available, they will be shared with the study team. This study is not intended to implement the findings on CS, only to report the results obtained to the study team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Multiple Myeloma | – | –Participants who will undergo tumor biopsy for management of multiple myeloma (MM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is open to interested patients with Multiple Myeloma (MM) of all genders and races from inside or outside Mount Sinai that will be undergoing tumor sampling (bone marrow or tissue) as part of their evaluation for salvage therapy. The research team will accept participants with a diagnosis of MM who self-refer, or are referred by their treating physician, who will be undergoing tumor biopsy (bone marrow or tissue) with the intention of receiving salvage systemic therapy for their MM. Interested individuals can contact the research team and learn more about the study. Potential participants would speak to one of the study staff over the phone, will be provided with further details about the study, pre-screened for eligibility, and set up to undergo informed consent.
Key inclusion criteria (6 listed)
- Patients must be 18 years of age at the time of registration.
- Participant must have an established diagnosis of relapsed Multiple Myeloma based on IMWG criteria, be willing to participate, and able to consent
- Participant must have a treating physician who agrees to participate in the study
- Participant will be undergoing a bone marrow biopsy or tumor biopsy as part of their standard of care.
- Patients must be willing to participate in this study and able to sign informed consent.
Key exclusion criteria (4 listed)
- Known diagnosis of AL amyloidosis, Waldenstrom Macroglobulinemia, POEMS, or Castleman´s disease.
- Diagnosis of cancer other than myeloma or skin cancer (squamous cell or basal cell) that is ongoing or treated within the last 2 years.
- Tumor sample inadequate or unavailable for analysis (e.g., due to insufficient number of tumor cells).
- Patient will not be receiving systemic MM-directed chemotherapy/immunotherapy in the following 2 months from the time tumor biopsy is performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total number of somatic Single-nucleotide variants (SNVs) per patient
Time frame: End of study at 30 months
The number of genetic alterations found in the genome through genetic sequencing and comparison to the most common genetic sequence. A given variant may describe an alteration that is benign, pathogenic, or of unknown significance.
25 secondary outcomes
Total number of somatic insertions (INS) per patient
Time frame: End of study at 30 months
Total number of somatic deletions (DEL) per patient
Time frame: End of study at 30 months
Number of SNVs per megabase of the MM genome
Time frame: End of study at 30 months
Number of INS per megabase of the MM genome
Time frame: End of study at 30 months
Number of DEL per megabase of the MM genome
Time frame: End of study at 30 months
Number of mutations per megabase among MM subgroups
Time frame: End of study at 30 months
Number of mutations per megabase among genomic regions for all MM and mutational subgroups
Time frame: End of study at 30 months
Gene mutations identified
Time frame: End of study at 30 months
Chromosomal abnormalities identified
Time frame: End of study at 30 months
Molecular signatures identified
Time frame: End of study at 30 months
Established Prognostic markers identified
Time frame: End of study at 30 months
Somatic variants identified as targets of FDA-approved drugs (pharmacogenomics variant data)
Time frame: End of study at 30 months
Network-informed key driver variants identified
Time frame: End of study at 30 months
Transcriptome variations identified
Time frame: End of study at 30 months
Germline mutations identified in cancer predisposition genes
Time frame: End of study at 30 months
FDA approved drugs available that block enzymes produced in those pathways identified
Time frame: End of study at 30 months
Treatment recommended by computational pipeline based on patient's clinical and genetic
Time frame: End of study at 30 months
Germline whole exome sequencing profile
Time frame: End of study at 30 months
Tumor genome whole exome sequencing profile
Time frame: End of study at 30 months
Tumor transcriptome profile
Time frame: End of study at 30 months
Single-cell sequencing profile
Time frame: End of study at 30 months
Cytometric profile
Time frame: End of study at 30 months
Signaling Pathways associated
Time frame: End of study at 30 months
Enzymes associated with each signaling pathway identified
Time frame: End of study at 30 months
Improvement of cancer sequencing-guided treatment recommendations by machine learning
Time frame: End of study at 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
Cesar Rodriguez Valdes, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 17 Aug 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of somatic Single-nucleotide variants (SNVs) per patient (time frame: End of study at 30 months). 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 17 Aug 2026.