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Clinical research of the efficacy and safety of Vitamin A acid combined with Rd scheme in multiple myeloma patients with the drug lenalidomide resistance,Single center, single arm, prospectie ? studies

Clinical research of the efficacy and safety of Vitamin A acid combined with Rd scheme in multiple myeloma patients with the drug lenalidomide resistance,Single center, single arm, prospectie ? studies

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-16008243
Enrollment
Unknown
Registered
2016-04-07
Start date
2016-04-08
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

1:Eligible patients into vitamin A acid joint Rd project group, all accept > 2 starting from the second cycle per cycle treatment curative effect evaluation of A cycle.Therapy for > = SD patients to d

Sponsors

Beijing university people's hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female, age unlimited; 2. The drug lenalidomide drug resistance in patients with multiple myeloma; 3. There is no obvious ventricular septal myocardial amyloidosis (heart colour to exceed 12 mm or less, the nt - BNP < 322); 4. Lung infection (if any) to effectively control; 5. Chronic viral hepatitis (if any) to effectively control;Surface (surface antigen positive need regular monitoring DNA copy number); 6. Liver function (transaminase, bilirubin)?2 times the upper limit of normal value; 7. Survival is expected to more than 3 months; 8 subjects (or their legal representatives) must sign an informed consent form, show that they understand the research purpose and the necessary research steps, and willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Always use to the degree of sustained and effective in patients with multiple myeloma, or has been used three drug treatment of patients; 2. The treatment of4 patients with disease progression in the process of solution to meet the need of researchers to evaluate the changes; 3. Patients with uncontrolled or serious cardiovascular disease, including 6 months before the group of myocardial infarction, New York heart association (NYHA) definition (appendix 3) grade III, IV, did not control angina pectoris, heart failure of clinically significant cardiac disease or cardiac amyloidosis. 4. Allergic to the drug lenalidomide or vitamin A acid; 5. With severe bone marrow suppression, according to the researchers judge may affect the treatment of patients; 6. According to the plan or the judgment of patients suffering from serious body disease or mental illness may interfere with participating in this clinical study; 7. Patients undergoing other experimental drug therapy; 8. Pregnancy or breast-feeding women.

Design outcomes

Primary

MeasureTime frame
complete response;

Secondary

MeasureTime frame
overall response rate;very good response rate;partial response rate;response rate;Survival Data Analysis;

Countries

China

Contacts

Public ContactJin Lu

Beijing university people's hospital

jin1lu@sina.com+86 13311491805

Outcome results

None listed

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