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Efficacy of Chidamide plus BVD versus BVD in patients with relapse/refractory MM: a prospective, multicenter, randomized controlled clinical trial

Efficacy of Chidamide plus BVD versus BVD in patients with relapse/refractory MM: a prospective, multicenter, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049723
Enrollment
Unknown
Registered
2021-08-08
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-19

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:Chidamide plus BVD
control group:BVD

Sponsors

Chongqing University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.The subjects aged over 18 years old were male and female; 2. Relapsed or refractory multiple myeloma patients; 3. Subjects with ECOG <= 2; 4. Subjects with an expected survival of more than 3 months; 5. For TBIL <= 2.0mg/dl, AST and ALT <= 3.0 ULN; 6. Subjects who have signed informed consent. Informed consent was signed by the patient or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family members should sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with known allergy to Chidamide or bendamustine; 2. Patients with other tumors or previous tumor history at the same time; 3. Known patients with hepatitis B virus or hepatitis C virus (HCV) activity, or human immunodeficiency virus (HIV) serological positive; 4. Patients with uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before enrollment, grade III - IV heart failure defined by New York Heart Association (NYHA), uncontrolled angina pectoris, congestive heart failure, clinically significant pericardial disease or cardiac amyloidosis (NT Pro BNP >= 1800pg / ml); 5. Patients with severe infectious diseases at the same time; 6. According to the protocol or the judgment of the researcher, patients with severe physical or mental diseases may interfere with the participation in this clinical study; Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the results of the study; 7. Patients receiving other experimental drugs; 8. Pregnant or lactating women; 9. Subjects considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
Overall response rate;related adverse reactions;

Secondary

MeasureTime frame
Patient tolerance;

Countries

China

Contacts

Public ContactLiu Yao

Chongqing University Cancer Hospital

648283926@qq.com+86 13228684685

Outcome results

None listed

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