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Clinical investigation on the efficacy and safety of Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) in relapsed and refractory multiply myeloma

Clinical investigation of Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) in relapsed and refractory multiply myeloma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INh-16008198
Enrollment
Unknown
Registered
2016-03-31
Start date
2016-04-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Multiple Myeloma

Interventions

Sponsors

Department of Hematology, Changzheng Hospital, The Second Military Medical University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients diagnosed as relapsed or refractory multiple myeloma with CD138-positive isotype, who are ineligible for hematopoietic stem cell transplantation or unwilling to receive hematopoietic stem cell transplantation; 2. Aged 18 to 75 years; 3. patients with an expected survival3 months; 4. Sign the consent form; 5. Organ function: 1) heart function: NYHA functional class 92%; 6. Karnofsky score >=60, ECOG score <=2; 7. Medication history: not receiving any chemotherapy in the last one month,2)not receiving any immunotherapy in the last three months.

Exclusion criteria

Exclusion criteria: 1. Patients infected with bacteria, fungi, viruses and other microorganisms at present; 2. Unexplained fever, body temperature> 38 degree C; 3. Patients with HIV-positive; 4. Patients infected with active HBV and HCV; 5. patients developed Myocardial infarction and severe arrhythmia in the past six months; 6. Patients with congenital immune deficiency; 7. Patients and(or) their families do not accept CAR-T treatment; 8. patients with pregnancy or in lactating period; 9. Receiving steroid hormone agents during CAR-T treatment; 10. Receiving other anti-cancer agents during CAR-T treatment; 11. Patients with history of epilepsy or other mental disorders who are unable to obey the medical orders, or patients who are judged as not appropriate for CAR-T treatment by researchers.

Design outcomes

Primary

MeasureTime frame
Ratio of bone marrow plasma cells;Monoclonal Immunoglobulin;Serum Free Light Chains;Urine Light Chain;

Secondary

MeasureTime frame
Hemoglobin;ß2- microglobulin;

Countries

China

Contacts

Public ContactJian Hou

Department of Hematology, The Myeloma & Lymphoma Center, Changzheng Hospital, The Second Military Medical University.

houjian@medmail.com.cn+86 21 81885421

Outcome results

None listed

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