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Clinical study of autologous hematopoietic stem cell transplantation combined with daretozumab in the treatment of multiple myeloma

Clinical study of autologous hematopoietic stem cell transplantation combined with daretozumab in the treatment of multiple myeloma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047227
Enrollment
Unknown
Registered
2021-06-11
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-02-01

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:Granulocyte macrophage colony stimulating factor (gm-gsf) 300 was used on + 29, + 36, + 43, + 50 days after transplantation µ g. On + 30 days, + 37 days, + 44 days, + 51 days, 16 mg
Control group:Direct access to maintenance therapy Maintenance therapy: lenalidomide 25mg QD Before transplantation, 28 days, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after tra

Sponsors

Sichuan Provicial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patient criteria: patients meeting the following criteria were recruited in this clinical trial: (1)Diagnosis of multiple myeloma; (2)Aged 18 to 65 years; (3)Karnofsky score >= 70; (4)Serum total bilirubin = 3 months. 2. Sign the written informed consent before screening.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women and women of childbearing age who are unwilling to take contraceptive measures; 2. Patients with severe dysfunction of important organs or diseases affecting the prognosis of treatment; 3. Combined with other uncontrollable diseases that may restrict patients to participate in the trial; 4. People with mental disorders / unable to obtain informed consent; 5. Drug addicts and long-term alcoholics affected the evaluation of the test results; 6. The researcher decided that it was not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression Free Survival;2 years overall survival;Safety;

Countries

China

Contacts

Public ContactChe Feifei

Sichuan Provicial People's Hospital

546200286@qq.com+86 13808083399

Outcome results

None listed

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