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A multi-center clinical study of the integrated autologous transplantation strategy of mobilization, collection, non-cryopreservation and transplantation for consolidation therapy of patients with newly diagnosed multiple myeloma

A multi-center clinical study of the integrated autologous transplantation strategy of mobilization, collection, non-cryopreservation and transplantation for consolidation therapy of patients with newly diagnosed multiple myeloma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052673
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-11-15
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

multiple myeloma

Interventions

Experimental group:All-in-one transplant
Control group:conventional holistic treatment

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years old; 2. Newly diagnosed multiple myeloma patients who are suitable for autologous hematopoietic stem cell transplantation; 3. Use standard induction chemotherapy regimens based on bortezomib (V), such as VRD, VD, VCD; 4. Induction chemotherapy to obtain partial remission (PR) or above, such as PR, VGPR, CR, sCR.

Exclusion criteria

Exclusion criteria: 1. Patients who have used CD38 monoclonal antibody, CAR-T and other immunotherapy before transplantation; 2. Pregnant and lactating women; 3. Patients with a history of clinically significant QTc interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year , Congestive heart failure (CHF), patients with symptomatic coronary heart disease requiring drug treatment; 4. Heart B-ultrasound showed that the width of pericardial cavity fluid dark area at end-diastole is >=10mm; 5. Patients with active bleeding; 6. Active infection, or persistent fever within 14 days before enrollment; 7. Those with active infection of HBV, HCV and HIV; 8. Less than 6 weeks after major organ surgery; 9. People with mental disorders/people who cannot obtain informed consent; 10. Patients who use drugs and alcohol for a long time, which affect the evaluation of the test results; 11. Multiple myeloma invades the central nervous system; 12. The researcher determines that it is not suitable to participate in this researcher.

Design outcomes

Primary

MeasureTime frame
2-year progression-free survival;The immune-cells count and T cell function at different time points;—

Secondary

MeasureTime frame
Two-year overall survival;Infection rate;Efficacy and economic benefits;The incidence of oral mucositis;—

Countries

China

Contacts

Public ContactHuang Xiaobing

Sichuan Provincial People's Hospital

huangxiaobing@med.uestc.edu.cn+86 18981838236

Outcome results

None listed

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