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A prospective research: CD38 monoclonal antibodies in multiple myeloma after autologous stem cell transplantation

A prospective research: CD38 monoclonal antibodies in multiple myeloma after autologous stem cell transplantation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044951
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Multiple Myeloma

Interventions

MRD negative group:Lenalidomide
experimental group:CD38 monoclonal antibodies
control group:Lenalidomide

Sponsors

Department of Hematology, the Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Early diagnosis of multiple myeloma (no type limit), and completion of induction therapy, high-dose Malphalan chemotherapy and autologous stem cell transplantation; 2.Age 35-70, regardless of gender and race; 3.Take the test voluntarily and sign the informed consent form; 4.ECOG score <= 2 points.

Exclusion criteria

Exclusion criteria: 1.Subjects have active infections, such as hepatitis B, tuberculosis, etc.; 2.The subjects main organ function is impaired: with severe cardiac insufficiency, cardiac ejection fraction EF less than 60%, or severe arrhythmia; with severe pulmonary insufficiency (obstructive and or restrictive ventilation disorder); Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are greater than 3 times the upper limit of normal (ULN); with severe renal insufficiency, renal function index (Cr) is greater than 2 times the upper limit of normal (ULN), or The 24-hour urine creatinine clearance rate Ccr is less than 50ml/min; the above researchers evaluated those who cannot tolerate the treatment; 3.Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 4.There are clinical symptoms of brain dysfunction or serious mental illness, unable to understand or follow the research plan; 5.Combined with other malignant tumors in need of treatment; 6.Patients who cannot guarantee the completion of the necessary treatment plan and follow-up observation; 7.The investigator judges that the subject cannot comply with the research requirements.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
objective response rate;clinical benefit rate;overall survival;Quality of Life;adverse events;serious adverse event;vital signs;laboratory indicators;

Countries

China

Contacts

Public ContactLuo Yun

Department of Hematology, The second affiliated hospital of Chongqing medical university

300333@cqmu.edu.cn+86 13452393932

Outcome results

None listed

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