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The prospective, controlled, multi-center phase III clinical trial of Allo-HSCT and double ASCT in patients with high-risk multiple myeloma

The prospective, controlled, multi-center phase III clinical trial of Allo-HSCT and double ASCT in patients with high-risk multiple myeloma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-17012370
Enrollment
Unknown
Registered
2017-08-15
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

Multiple myeloma

Interventions

Group of tandem autologous stem-cell transplantation:Double ASCT
Group of allogeneic stem-cell transplantation:Allo-SCT

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Between 18 and 60 years old; 2) Patients who meet the 2014 IMWG multiple myeloma diagnostic criteria; 3) Patients with 4 or more prognostic scores according to the first part of the study; 4) Symptomatic, measurablenewly diagnosed MM patients; 5) ECOG behavior status between 0-3 level; expected survival time> 6 months; 6) Did not receive any anti-tumor therapy before (except glucocorticoid alone); 7) No other malignancy history; 8) No other serious illnesses in conflict with this program; 9) Patients understand and are willing to participate in this clinical trial and provide signed informed consent; 10) All patients must agree to take effective contraceptives during the study and in the termination of treatment within 6 months, women of childbearing age must be negative in the pregnancy test before treatment.

Exclusion criteria

Exclusion criteria: 1) Have participated in other clinical studies in the last 3 months; 2) Secondary myeloma after chemotherapy or radiotherapy of other malignant tumors; 3) Received treatment for multiple myeloma before enrollment (except glucocorticoid alone); 4) Any other malignancy history before or at the time of diagnosis; 5) Decompensated heart failure, dilated cardiomyopathy, ECG showed significant reduction in ST segment of coronary heart disease and myocardial infarction occurred in the last 6 months; 6) Patients with uncontrolled severe infection or organic disease; 7) Liver dysfunction (transaminase exceeds the normal value limit of 4 times and / or blood bilirubin > 2.0mg / dl); 8) Have brain disorders or severe mental illness; 9) Lactating or pregnant women.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
efficacy rate;overall survival;minimal residual disease;

Countries

China

Contacts

Public ContactJuan Li

The First Affiliated Hospital of Sun Yat-sen University

13719209240@163.com+86 13719209240

Outcome results

None listed

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