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A prospective observational study of Bortezomib, Dexamethasone and Decitabin in the treatment of recurrent / refractory multiple myeloma.

A prospective observational study of Bortezomib, Dexamethasone and Decitabin in the treatment of recurrent / refractory multiple myeloma.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17013860
Enrollment
Unknown
Registered
2017-12-12
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Multiple Myeloma

Interventions

Case series:reduced dosage

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Signed informed consent; aged 18 to 75 years; the cell morphology, flow cytometry analysis and examination confirmed the diagnosis of multiple myeloma patients accepted standard treatment efficacy after the poor, diagnosed with relapsed and refractory multiple myeloma; myeloma lesions in the screening period M protein test (obtained by serum / urine protein electrophoresis) to the determination of the level required to meet at least one of the following indicators: detection of serum M protein is more than 10g/L (protein electrophoresis) or IgA more than 7.5g/L (turbidimetry immunoglobulin quantitative) urine M protein is more than 0.2g/24h; ECOG score of 2 or less; expected survival of more than 3 month; laboratory examination results should meet the following requirements: at least the index absolute neutrophil count (ANC) = 1 *10^9/L; at least platelet (PLT) = 50 * 10^9/L; aspartate aminotransferase (AST/SGOT) is less than 2.5 * ULN; alanine aminotransferase ( ALT/SGPT) is less than 2.5 * ULN; alkaline phosphatase (ALP) is less than 2.5 * ULN; total bilirubin (TBIL) is less than 1.5 * ULN; at least creatinine clearance rate (Ccr) is 30ml/min

Exclusion criteria

Exclusion criteria: Stem cell transplantation, manifested as graft-versus-host disease, when informed consent illness was actived or required immunosuppressive therapy; a history of allergic reactions or contraindications to any drug test composition; 4 weeks received any routine or research the anti myeloma drug treatment (manual note for the anti myeloma therapy; thalidomide maintenance treatment shortened to 2 weeks before the test (if) or radiotherapy had received radiotherapy can shorten the time limit to test before 2 weeks); 2 weeks underwent major surgery; plasma cell leukemia; combined with other malignant tumor with poorly controlled hypertension or; clinical significance (such as activity) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (signed informed consent before 6 months), myocardial infarction (signed informed consent before 6 months) Unstable angina, New York Heart Association class II or above the level of congestive heart failure or severe arrhythmia or poor control of the potential impact on the study of treatment; combined with other serious organic disease and suffering from mental disorders; need treatment systemic active infection; known HIV positive patients or clinical the activity of the A, B and C hepatitis; pregnancy or breast-feeding women; dementia, mental abnormalities or any informed consent for understanding mental illness.

Design outcomes

Primary

MeasureTime frame
immunofixation electrophoresis;

Countries

China

Contacts

Public ContactFang Baijun

He'nan Cancer Hospital

fdation@126.com+86 13526607830

Outcome results

None listed

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