Multiple MyelomaNCT07045168
Risk-adapted Therapeutic Strategy in +1q NDMM
An observational study of Multiple Myeloma, run by FengYan Jin at 1 site in China.
Trial summary
This real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- risk-scoring model
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 4 Jul 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newly diagnosed NDMM by 2014 IMWG criteria
Who may be able to join
- Age >=18, or >=65 and fit according to IMWG-FI.
- Newly diagnosed NDMM by 2014 IMWG criteria.
- Adequate organ function for systemic therapy.
- Signed informed consent.
Who cannot join
- Active infections requiring systemic treatment.
- Unstable angina, NYHA class III-IV heart failure, or uncontrolled arrhythmias.
- History of hematologic or solid tumors treated with chemo/radiotherapy within 5 years.
- Current malignancies requiring therapy.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study
This real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint.
- Conditions
- Multiple Myeloma
- Being tested
- risk-scoring model
- Keywords
- Multiple Myeloma, Risk-adapted therapeutic strategy, +1q MM, high-risk MM, minimal residual disease
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk-scoring modelOther
Also called Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma
This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point),intermediate- (1-3 points), and high-risk (4-7 points) groups.
| Study group | Role | What they receive |
|---|---|---|
| low-risk +1q NDMM patients | This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting International Staging System (ISS) stage III, hypercalcemia, high lactate dehydrogenase (LDH), and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point) . Receives: Other: risk-scoring model | |
| intermediate/high-risk +1q NDMM patients | This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q was classified into intermediate- (1-3 points) and high-risk (4-7 points) groups. Receives: Other: risk-scoring model | |
| 1q negativity low-risk group | Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification. | |
| 1q negativity high-risk group | Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD negativity rate
To compare MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
Measured: through study completion, up to 2 years
sustained MRD negativity rate
To compare sustained MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
Measured: through study completion, up to 2 years
Progression-Free Survival (PFS)
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
Measured: through study completion, up to 2 years
Overall Survival (OS)
OS were calculated from the time of enrollment to death or the last follow-up
Measured: through study completion, up to 2 years
objective response rate
To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR).
Measured: through study completion, up to 2 years
Treatment related adverse event(TRAE)
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.
Measured: through study completion, up to 2 years
Secondary outcomes (4)
differences between MRD-negative and MRD-positive patients
Number of participants with distinct immunological (T-cell subsets by flow cytometry), inflammatory (CRP, IL-6 levels), genomic (mutational burden by NGS), and proteomic (LC-MS/MS) signatures in MRD-negative vs. MRD-positive patients.
Measured: through study completion, up to 2 years
elderly +1q NDMM patients
Number of participants achieving MRD negativity (by next-generation sequencing [NGS] at 10^-5 sensitivity) and progression-free survival (PFS) at 24 months in elderly intermediate/high-risk +1q NDMM patients receiving MRD-tailored therapy.
Measured: through study completion, up to 2 years
The efficacy of 1q negativity patients
Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The efficacy of these patients were compared with those of patients stratified by 1q risk through objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR) .
Measured: through study completion, up to 2 years
The survival of 1q negativity patients
Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The survival of these patients were compared with those of patients stratified by 1q risk through PFS and OS
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion4 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FengYan Jin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FengYan Jin, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045168
- Sponsor's protocol ID
- Risk-adapted therapy
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van de Donk NWCJ, Pawlyn C, Yong KL. Multiple myeloma. Lancet. 2021 Jan 30;397(10272):410-427. doi: 10.1016/S0140-6736(21)00135-5.
PubMed 33516340Zamagni E, Barbato S, Cavo M. How I treat high-risk multiple myeloma. Blood. 2022 May 12;139(19):2889-2903. doi: 10.1182/blood.2020008733.
PubMed 34727187Kumar SK, Rajkumar SV. The multiple myelomas - current concepts in cytogenetic classification and therapy. Nat Rev Clin Oncol. 2018 Jul;15(7):409-421. doi: 10.1038/s41571-018-0018-y.
PubMed 29686421Sonneveld P, Avet-Loiseau H, Lonial S, Usmani S, Siegel D, Anderson KC, Chng WJ, Moreau P, Attal M, Kyle RA, Caers J, Hillengass J, San Miguel J, van de Donk NW, Einsele H, Blade J, Durie BG, Goldschmidt H, Mateos MV, Palumbo A, Orlowski R. Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group. Blood. 2016 Jun 16;127(24):2955-62. doi: 10.1182/blood-2016-01-631200. Epub 2016 Mar 21.
PubMed 27002115Croft J, Ellis S, Sherborne AL, Sharp K, Price A, Jenner MW, Drayson MT, Owen RG, Chown S, Lindsay J, Karunanithi K, Hunter H, Gregory WM, Davies FE, Morgan GJ, Cook G, Atanesyan L, Savola S, Cairns DA, Jackson G, Houlston RS, Kaiser MF. Copy number evolution and its relationship with patient outcome-an analysis of 178 matched presentation-relapse tumor pairs from the Myeloma XI trial. Leukemia. 2021 Jul;35(7):2043-2053. doi: 10.1038/s41375-020-01096-y. Epub 2020 Dec 1.
PubMed 33262523Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.
PubMed 30704229D'Agostino M, Cairns DA, Lahuerta JJ, Wester R, Bertsch U, Waage A, Zamagni E, Mateos MV, Dall'Olio D, van de Donk NWCJ, Jackson G, Rocchi S, Salwender H, Blade Creixenti J, van der Holt B, Castellani G, Bonello F, Capra A, Mai EK, Durig J, Gay F, Zweegman S, Cavo M, Kaiser MF, Goldschmidt H, Hernandez Rivas JM, Larocca A, Cook G, San-Miguel JF, Boccadoro M, Sonneveld P. Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project. J Clin Oncol. 2022 Oct 10;40(29):3406-3418. doi: 10.1200/JCO.21.02614. Epub 2022 May 23.
PubMed 35605179Abdallah NH, Binder M, Rajkumar SV, Greipp PT, Kapoor P, Dispenzieri A, Gertz MA, Baughn LB, Lacy MQ, Hayman SR, Buadi FK, Dingli D, Go RS, Hwa YL, Fonder AL, Hobbs MA, Lin Y, Leung N, Kourelis T, Warsame R, Siddiqui MA, Kyle RA, Bergsagel PL, Fonseca R, Ketterling RP, Kumar SK. A simple additive staging system for newly diagnosed multiple myeloma. Blood Cancer J. 2022 Jan 31;12(1):21. doi: 10.1038/s41408-022-00611-x.
PubMed 35102148Walker BA, Mavrommatis K, Wardell CP, Ashby TC, Bauer M, Davies F, Rosenthal A, Wang H, Qu P, Hoering A, Samur M, Towfic F, Ortiz M, Flynt E, Yu Z, Yang Z, Rozelle D, Obenauer J, Trotter M, Auclair D, Keats J, Bolli N, Fulciniti M, Szalat R, Moreau P, Durie B, Stewart AK, Goldschmidt H, Raab MS, Einsele H, Sonneveld P, San Miguel J, Lonial S, Jackson GH, Anderson KC, Avet-Loiseau H, Munshi N, Thakurta A, Morgan G. A high-risk, Double-Hit, group of newly diagnosed myeloma identified by genomic analysis. Leukemia. 2019 Jan;33(1):159-170. doi: 10.1038/s41375-018-0196-8. Epub 2018 Jul 2.
PubMed 29967379Yang P, Chen H, Liang X, Xu W, Yu S, Huang W, Yi X, Guo Q, Tian M, Yue T, Li M, Zhang Y, Zhang M, Yan Y, Hu Z, Kumar SK, Zhou F, Dai Y, Jin F. Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma. Am J Hematol. 2023 Feb;98(2):251-263. doi: 10.1002/ajh.26774. Epub 2022 Nov 8.
PubMed 36309982
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT07045168
- Acronym / sponsor ID
- Risk-adapted therapy
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Risk-adapted therapeutic strategy, +1q MM, high-risk MM, minimal residual disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- FengYan JinUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 4 Jul 2029 (estimated)
- First posted
- 1 Jul 2025 (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 real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low-risk +1q NDMM patients | – | Other: risk-scoring modelThis system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting International Staging System (ISS) stage III, hypercalcemia, high lactate dehydrogenase (LDH), and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point) . |
| intermediate/high-risk +1q NDMM patients | – | Other: risk-scoring modelThis system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q was classified into intermediate- (1-3 points) and high-risk (4-7 points) groups. |
| 1q negativity low-risk group | – | –Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification. |
| 1q negativity high-risk group | – | –Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed NDMM by 2014 IMWG criteria
Key inclusion criteria (4 listed)
- Age >=18, or >=65 and fit according to IMWG-FI.
- Newly diagnosed NDMM by 2014 IMWG criteria.
- Adequate organ function for systemic therapy.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Active infections requiring systemic treatment.
- Unstable angina, NYHA class III-IV heart failure, or uncontrolled arrhythmias.
- History of hematologic or solid tumors treated with chemo/radiotherapy within 5 years.
- Current malignancies requiring therapy.
- Refusal to participate.
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 |
|---|---|---|
| risk-scoring modelAlso: Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myelomaThis system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point),intermediate- (1-3 points), and high-risk (4-7 points) groups. | Other | intermediate/high-risk +1q NDMM patients, low-risk +1q NDMM patients |
Primary outcome
MRD negativity rate
Time frame: through study completion, up to 2 years
To compare MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
sustained MRD negativity rate
Time frame: through study completion, up to 2 years
To compare sustained MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
Progression-Free Survival (PFS)
Time frame: through study completion, up to 2 years
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
Overall Survival (OS)
Time frame: through study completion, up to 2 years
OS were calculated from the time of enrollment to death or the last follow-up
objective response rate
Time frame: through study completion, up to 2 years
To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR).
Treatment related adverse event(TRAE)
Time frame: through study completion, up to 2 years
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.
4 secondary outcomes
differences between MRD-negative and MRD-positive patients
Time frame: through study completion, up to 2 years
elderly +1q NDMM patients
Time frame: through study completion, up to 2 years
The efficacy of 1q negativity patients
Time frame: through study completion, up to 2 years
The survival of 1q negativity patients
Time frame: through study completion, up to 2 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 15 Sep 2025.
- Background: PubMed 33516340van de Donk NWCJ, Pawlyn C, Yong KL. Multiple myeloma. Lancet. 2021 Jan 30;397(10272):410-427. doi: 10.1016/S0140-6736(21)00135-5.
- Background: PubMed 34727187Zamagni E, Barbato S, Cavo M. How I treat high-risk multiple myeloma. Blood. 2022 May 12;139(19):2889-2903. doi: 10.1182/blood.2020008733.
- Background: PubMed 29686421Kumar SK, Rajkumar SV. The multiple myelomas - current concepts in cytogenetic classification and therapy. Nat Rev Clin Oncol. 2018 Jul;15(7):409-421. doi: 10.1038/s41571-018-0018-y.
- Background: PubMed 27002115Sonneveld P, Avet-Loiseau H, Lonial S, Usmani S, Siegel D, Anderson KC, Chng WJ, Moreau P, Attal M, Kyle RA, Caers J, Hillengass J, San Miguel J, van de Donk NW, Einsele H, Blade J, Durie BG, Goldschmidt H, Mateos MV, Palumbo A, Orlowski R. Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group. Blood. 2016 Jun 16;127(24):2955-62. doi: 10.1182/blood-2016-01-631200. Epub 2016 Mar 21.
- Background: PubMed 33262523Croft J, Ellis S, Sherborne AL, Sharp K, Price A, Jenner MW, Drayson MT, Owen RG, Chown S, Lindsay J, Karunanithi K, Hunter H, Gregory WM, Davies FE, Morgan GJ, Cook G, Atanesyan L, Savola S, Cairns DA, Jackson G, Houlston RS, Kaiser MF. Copy number evolution and its relationship with patient outcome-an analysis of 178 matched presentation-relapse tumor pairs from the Myeloma XI trial. Leukemia. 2021 Jul;35(7):2043-2053. doi: 10.1038/s41375-020-01096-y. Epub 2020 Dec 1.
- Background: PubMed 30704229Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.
- Background: PubMed 35605179D'Agostino M, Cairns DA, Lahuerta JJ, Wester R, Bertsch U, Waage A, Zamagni E, Mateos MV, Dall'Olio D, van de Donk NWCJ, Jackson G, Rocchi S, Salwender H, Blade Creixenti J, van der Holt B, Castellani G, Bonello F, Capra A, Mai EK, Durig J, Gay F, Zweegman S, Cavo M, Kaiser MF, Goldschmidt H, Hernandez Rivas JM, Larocca A, Cook G, San-Miguel JF, Boccadoro M, Sonneveld P. Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project. J Clin Oncol. 2022 Oct 10;40(29):3406-3418. doi: 10.1200/JCO.21.02614. Epub 2022 May 23.
- Background: PubMed 35102148Abdallah NH, Binder M, Rajkumar SV, Greipp PT, Kapoor P, Dispenzieri A, Gertz MA, Baughn LB, Lacy MQ, Hayman SR, Buadi FK, Dingli D, Go RS, Hwa YL, Fonder AL, Hobbs MA, Lin Y, Leung N, Kourelis T, Warsame R, Siddiqui MA, Kyle RA, Bergsagel PL, Fonseca R, Ketterling RP, Kumar SK. A simple additive staging system for newly diagnosed multiple myeloma. Blood Cancer J. 2022 Jan 31;12(1):21. doi: 10.1038/s41408-022-00611-x.
- Background: PubMed 29967379Walker BA, Mavrommatis K, Wardell CP, Ashby TC, Bauer M, Davies F, Rosenthal A, Wang H, Qu P, Hoering A, Samur M, Towfic F, Ortiz M, Flynt E, Yu Z, Yang Z, Rozelle D, Obenauer J, Trotter M, Auclair D, Keats J, Bolli N, Fulciniti M, Szalat R, Moreau P, Durie B, Stewart AK, Goldschmidt H, Raab MS, Einsele H, Sonneveld P, San Miguel J, Lonial S, Jackson GH, Anderson KC, Avet-Loiseau H, Munshi N, Thakurta A, Morgan G. A high-risk, Double-Hit, group of newly diagnosed myeloma identified by genomic analysis. Leukemia. 2019 Jan;33(1):159-170. doi: 10.1038/s41375-018-0196-8. Epub 2018 Jul 2.
- Background: PubMed 36309982Yang P, Chen H, Liang X, Xu W, Yu S, Huang W, Yi X, Guo Q, Tian M, Yue T, Li M, Zhang Y, Zhang M, Yan Y, Hu Z, Kumar SK, Zhou F, Dai Y, Jin F. Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma. Am J Hematol. 2023 Feb;98(2):251-263. doi: 10.1002/ajh.26774. Epub 2022 Nov 8.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 FengYan Jin at 1 site in China.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Sep 2025. 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 China. 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?
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?
MRD negativity rate (time frame: through study completion, up to 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045168, which also lists 10 linked publications.
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 15 Sep 2025.