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Dynamic monitoring of minimal residual disease (MRD) in patients with newly diagnosed multiple myeloma: a prospective, multicenter, open-label and observational study

Dynamic monitoring of minimal residual disease (MRD) in patients with newly diagnosed multiple myeloma: a prospective, multicenter, open-label and observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056947
Enrollment
Unknown
Registered
2022-02-24
Start date
2022-02-24
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma

Interventions

Case series:Nil

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age above 18, regardless of gender; 2. According to the IMWG diagnostic criteria for multiple myeloma in 2014, the patient was diagnosed as symptomatic multiple myeloma and had measurable secretory disease, which was evaluated by the central laboratory and defined as any of the following: 1) IgG myeloma: serum M protein level = 10g/L or urine M protein level = 200mg/24h; 2) IgA, IgD, IgM or IgE myeloma: serum M protein level = 5g/L or urine M protein level = 200mg/24h; 3) Light chain type myeloma without measurable disease in serum or urine: serum free light chain = 100mg/L and abnormal ratio of serum free light chain; 4) Receive regular anti multiple myeloma therapy; 5) Women of childbearing age must have negative pregnancy examination before enrollment, and agree to use contraceptive measures during the study and within 3 months after the last treatment; 6) Ask for the informed consent of the subjects and their families, and sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Non active multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammaglobulin disease of unknown significance) or smoking myeloma; 2. Non initial diagnosis and treatment; 3. Have a history of other malignancies except multiple myeloma within 3 years before screening (except for cured malignancies with a very low risk of recurrence within 3 years); 4. Psychotic subjects who are not easy to control; 5. Subjects who the researcher thinks are not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;To evaluate the impact of MRD-negative duration on survival in different subtype MM, such as the patients = 65 years or carrying HRCA.;To assess whether autologous hematopoietic stem cell transplantation (ASCT) or maintenance therapy prolongs the duration of MRD negativity;

Countries

China

Contacts

Public ContactFengyan JIin

The First Hospital of Jilin University

fengyanjin@jlu.edu.cn+86 13844989638

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026