AzTrials
AzTrials

Multiple MyelomaNICHENCT04645199

National Longitudinal Cohort of Hematological Diseases

An observational study of Multiple Myeloma and Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Background Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology. Read more about this study

Who is it for?
Any age
How many people
2,300 participants
Where
1 siteChina
Study dates
1 Dec 2020to 1 Dec 2030
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: Patients who were diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders or received bone marrow transplantation in the investigating hospitals from January 1, 2020.

Who may be able to join

  • Patients who were diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders or received bone marrow transplantation in the investigating hospitals from January 1, 2020.

Who cannot join

  • Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.
  • Alcohol and drug addictions affect their ability to comply with study requirements.
  • According to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhen Song, MD contact

+86 02223909051

cir@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 300000

    Zhen Song, MD, 022-23909051, songzhen@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: National Longitudinal Cohort of Hematological Diseases (NICHE)

Background Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology. The purpose of this study is to analyze the incidence and risk factors of major blood diseases, the treatment methods, prognosis and medical expenses of these patients in China.

Method The study will include patients diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders, autoimmune hemolytic anemia, large granular lymphocyte leukemia, essential thrombocythemia, blood infection or received bone marrow transplantation in the investigating hospitals from January 1, 2020, and collect basic information, diagnostic and treatment information, prognosis information, as well as medical expense information from medical records. In its current form, the NICHE registry incorporates historical data (collected from 2000) and is systematically collecting prospective data in two phases with broadening reach, and prospectively follow-up to collect the prognosis information.

Medical subject headings
Multiple Myeloma, Leukemia, Myeloid, Acute, Hemophilia A, Hemophilia B, Myelodysplastic Syndromes, Lymphoma, Leukemia, Anemia, Aplastic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and distribution

    To describe the incidence and population characteristics of hematological diseases in China, such as: leukemia, multiple myeloma, hemophilia, aplastic anemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood disease infection, et al., and analyze the risk factors associated with these diseases.

    Measured: 5 years

Secondary outcomes (2)

  1. Therapeutic evaluation

    To analyze the therapeutic efficacy and long-term prognosis of patients with hematological diseases, such as: leukemia, multiple myeloma, hemophilia, aplastic anemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood disease infection, et al.

    Measured: 5 years

  2. Health economic evaluation

    To conduct health economic evaluation on patients with hematological diseases, such as: leukemia, multiple myeloma, hemophilia, aplastic anemia, myelodysplastic syndrome, lymphoma, bleeding disorders, blood disease infection, et al.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2020
  2. Study start1 Dec 2020
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

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
2,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04645199
Sponsor's protocol ID
NICHE-cohort
Acronym
NICHE
Status last verified
Dec 2025
First submitted
13 Nov 2020
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tian L, Zhang L, Li R, Wang W, Li W, Pan H, Gao Z, Zhao J, Luo Y, Fang L, Shi J. Patterns of clonal hematopoiesis in aplastic anemia under immunosuppressive therapy. Leukemia. 2026 Sep 3. doi: 10.1038/s41375-026-03048-4. Online ahead of print.

    PubMed 42693160

  • Lu N, Liu L, Cao Y, Zhang R, Zhai W, Chen X, Ma Q, Yang D, Pang A, Wei J, He Y, Feng S, Han M, Jiang E. Efficacy and safety of mitoxantrone hydrochloride liposome-containing regimens in treating refractory/relapsed acute myeloid leukemia. Discov Oncol. 2025 May 12;16(1):727. doi: 10.1007/s12672-025-02526-y.

    PubMed 40353947

  • Yan W, Shi L, Xu J, Li L, Cui J, Liu Y, Zhou J, Du C, Yu T, Zhang S, Lv R, Sui W, Deng S, Li X, Du X, Xu Y, Zou D, Qiu L, Hao M, An G. Clinical implications of residual normal plasma cells within bone marrow across various disease stages in multiple myeloma. Leukemia. 2024 Oct;38(10):2235-2245. doi: 10.1038/s41375-024-02366-9. Epub 2024 Aug 2.

    PubMed 39095502

  • Gao H, Wang J, Zheng X, Pei X, Zheng Y, Zhai W, Zhang R, Chen X, Ma Q, Wei J, Yang D, Pang A, He Y, Feng S, Cao Y, Jiang E. Ursodeoxycholic acid does not reduce SARS-CoV-2 infection in newly allogeneic hematopoietic stem cell transplantation recipients: a prospective NICHE cohort. Front Cell Infect Microbiol. 2024 Mar 5;14:1324019. doi: 10.3389/fcimb.2024.1324019. eCollection 2024.

    PubMed 38505288

  • Cui J, Yu T, Lv R, Liu J, Fan H, Yan W, Xu J, Du C, Deng S, Sui W, Ho M, Xu Y, Anderson KC, Dong X, Qiu L, An G. Longitudinal genetically detectable minimal residual disease by fluorescence in situ hybridization confers a poor prognosis in myeloma. Ther Adv Med Oncol. 2024 Jan 19;16:17588359231221340. doi: 10.1177/17588359231221340. eCollection 2024.

    PubMed 38249329

  • Fan H, Wang B, Shi L, Pan N, Yan W, Xu J, Gong L, Li L, Liu Y, Du C, Cui J, Zhu G, Deng S, Sui W, Xu Y, Yi S, Hao M, Zou D, Chen X, Qiu L, An G. Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM). Clin Cancer Res. 2024 Mar 15;30(6):1131-1142. doi: 10.1158/1078-0432.CCR-23-2767.

    PubMed 38170583

  • Chen Y, Liu J, Shao S, Song Z, Ma Y, Tuo Y, Fang L, Xu Y, Xu B, Gu W, Cao X, Chen J, Yang Y, Wang P, Zhang J, Xu Y, Yu D, Hou P, Meng K, Li Z, Liu G, Qu X, Ji L, Yang R, Zhang L. Characteristics and outcomes of COVID-19 in Chinese immune thrombocytopenia patients: A prospective cohort study. Br J Haematol. 2024 Apr;204(4):1207-1218. doi: 10.1111/bjh.19198. Epub 2023 Nov 15.

    PubMed 37967471

  • Yan W, Xu J, Fan H, Li L, Cui J, Du C, Deng S, Sui W, Xu Y, Hao M, Anderson KC, Zou D, Qiu L, An G. Early relapse within 18 months is a powerful dynamic predictor for prognosis and could revise static risk distribution in multiple myeloma. Cancer. 2024 Feb 1;130(3):421-432. doi: 10.1002/cncr.35056. Epub 2023 Oct 17.

    PubMed 37846845

  • Liu J, Yan W, Fan H, Xu J, Li L, Du C, Mao X, Yan Y, Xu Y, Sui W, Deng S, Yi S, Anderson KC, Qiu L, Zou D, An G. Clinical Benefit of Autologous Stem Cell Transplantation for Patients with Multiple Myeloma Achieving Undetectable Minimal Residual Disease after Induction Treatment. Cancer Res Commun. 2023 Sep 6;3(9):1770-1780. doi: 10.1158/2767-9764.CRC-23-0185. eCollection 2023 Sep.

    PubMed 37680953

  • Cui J, Lv R, Yu T, Yan W, Xu J, Fan H, Li L, Liu Y, Du C, Deng S, Sui W, Xu Y, Yi S, Zou D, Qiu L, An G. Minor clone of del(17p) provides a reservoir for relapse in multiple myeloma. Haematologica. 2024 Feb 1;109(2):591-603. doi: 10.3324/haematol.2023.283533.

    PubMed 37534514

  • Fan H, Wang W, Zhang Y, Wang J, Cheng T, Qiu L, Wang X, Xia Z, An G. Current treatment paradigm and survival outcomes among patients with newly diagnosed multiple myeloma in China: a retrospective multicenter study. Cancer Biol Med. 2023 Jan 12;20(1):77-87. doi: 10.20892/j.issn.2095-3941.2022.0612.

    PubMed 36647781

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma and Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 1 inclusion and 3 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 12 Feb 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 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?

Contact Zhen Song, MD (+86 02223909051, cir@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and distribution (time frame: 5 years). 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 NCT04645199, which also lists 11 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 12 Feb 2026.

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