Multiple MyelomaTRANSFORMMNCT05361694
Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions
An observational study of Multiple Myeloma and Smoldering Multiple Myeloma, run by University of Miami at 1 site in United States.
Trial summary
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2022to 1 Jul 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants diagnosed with MGUS or SMM.
Who may be able to join
- Diagnosis of MGUS and SMM will be made in accordance with the clinical diagnostic criteria set forth by the 2014 International Myeloma Working Group (IMWG) Revised Criteria.2
- The diagnoses will be confirmed by either serum/urine protein electrophoresis, immunofixation and light-chain assays; or immunohistochemistry analyses of the bone marrow biopsy, or a combination of these tests.
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- The patient must be competent to sign an informed consent form.
Who cannot join
- A diagnosis of MM as defined as any patient with detectable M-protein in blood and/or urine, monoclonal plasma cells in the bone marrow, and evidence of end-organ damage based on the Calcium Elevation, Renal Failure, Anemia, and Bone Disease (CRAB) criteria and/or myeloma-defining events.
- Patients who have received previous therapy for MM.
- Patients with known plasma cell or related lymphoid (e.g. lymphoplasmacytic lymphoma, Amyloid Light chain (AL) amyloidosis)
- Confirmation of pathological diagnosis is required either from the initial pathology review report or review from the UM/SCCC Hematopathologist in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group (IMWG) or World Health Organization (WHO). Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the patient during sampling required for routine patient care or required testing on a University of Miami (UM) /Sylvester Comprehensive Cancer Center (SCCC) research protocol will be used for diagnosis.
- Active symptomatic major organ disorder that would increase the risk of biopsy or other procedure, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
- Active concomitant medical or psychological illnesses that may increase the risk to the patient or inability to obtain informed consent, at the discretion of the Principal Investigator.
- Pregnant or breast-feeding women will not be eligible for any aspect of this protocol.
- Prisoners will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Hospitals
Miami, Florida, 33136
Carl Landgren, MD, 305-243-6578, col15@miami.edu
Carl Landgren, MD
About this study
Official title: Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
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 MGUS or SMM | Participants with either Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SMM) will be followed for disease progression to active multiple myeloma (MM) for up to 5 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of progression to active Multiple Myeloma (MM)
The rate of progression to active multiple myeloma in participants with tumors with and without myeloma defining genomic events as evaluated by treating physician via clinical assessments (including low-input DNA whole-genome sequencing)
Measured: Up to 5 years
Secondary outcomes (4)
Frequency of participant conversion from MGUS/SMM to Myeloma defining genomic events
As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
Measured: Up to 5 years
Frequency of participant conversion from MGUS/SMM to associated progressive phenotype
As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
Measured: Up to 5 years
Rate of participant conversion from MGUS/SMM to Myeloma defining genomic events
As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
Measured: Up to 5 years
Rate of participant conversion from MGUS/SMM to associated progressive phenotype
As per treating physician evaluation of clinical assessments (including low-input DNA whole-genome sequencing)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start12 Apr 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
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.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Ola Landgren, MD, PhD, University of Miami
- Investigators
- Carl Landgren, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361694
- Sponsor's protocol ID
- 20220067
- Acronym
- TRANSFORMM
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions (TRANSFORMM)
- ClinicalTrials.gov ID
- NCT05361694
- Acronym / sponsor ID
- TRANSFORMM / 20220067
- Conditions
- Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 May 2022 (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.
The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with MGUS or SMM | – | –Participants with either Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SMM) will be followed for disease progression to active multiple myeloma (MM) for up to 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants diagnosed with MGUS or SMM.
Key inclusion criteria (5 listed)
- Diagnosis of MGUS and SMM will be made in accordance with the clinical diagnostic criteria set forth by the 2014 International Myeloma Working Group (IMWG) Revised Criteria.2
- The diagnoses will be confirmed by either serum/urine protein electrophoresis, immunofixation and light-chain assays; or immunohistochemistry analyses of the bone marrow biopsy, or a combination of these tests.
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- The patient must be competent to sign an informed consent form.
Key exclusion criteria (8 listed)
- A diagnosis of MM as defined as any patient with detectable M-protein in blood and/or urine, monoclonal plasma cells in the bone marrow, and evidence of end-organ damage based on the Calcium Elevation, Renal Failure, Anemia, and Bone Disease (CRAB) criteria and/or myeloma-defining events.
- Confirmation of pathological diagnosis is required either from the initial pathology review report or review from the UM/SCCC Hematopathologist in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group (IMWG) or World Health Organization (WHO). Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the patient during sampling required for routine patient care or required testing on a University of Miami (UM) /Sylvester Comprehensive Cancer Center (SCCC) research protocol will be used for diagnosis.
- Active symptomatic major organ disorder that would increase the risk of biopsy or other procedure, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
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
Rate of progression to active Multiple Myeloma (MM)
Time frame: Up to 5 years
The rate of progression to active multiple myeloma in participants with tumors with and without myeloma defining genomic events as evaluated by treating physician via clinical assessments (including low-input DNA whole-genome sequencing)
4 secondary outcomes
Frequency of participant conversion from MGUS/SMM to Myeloma defining genomic events
Time frame: Up to 5 years
Frequency of participant conversion from MGUS/SMM to associated progressive phenotype
Time frame: Up to 5 years
Rate of participant conversion from MGUS/SMM to Myeloma defining genomic events
Time frame: Up to 5 years
Rate of participant conversion from MGUS/SMM to associated progressive phenotype
Time frame: Up to 5 years
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 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Carl Landgren, MD principal investigator
University of Miami
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 and Smoldering Multiple Myeloma, run by University of Miami 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 5 inclusion and 8 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 9 Apr 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?
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 Carl Landgren, MD (3052436578, col15@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of progression to active Multiple Myeloma (MM) (time frame: Up to 5 years). 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 9 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.